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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05153239
Registration number
NCT05153239
Ethics application status
Date submitted
29/11/2021
Date registered
10/12/2021
Date last updated
2/08/2024
Titles & IDs
Public title
Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)
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Scientific title
A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)
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Secondary ID [1]
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PM1183-C-008-21
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Irinotecan
Treatment: Drugs - Lurbinectedin
Treatment: Drugs - Irinotecan
Treatment: Drugs - Topotecan
Treatment: Drugs - Lurbinectedin
Experimental: Lurbinectedin - Patients will consecutively receive lurbinectedin on Day 1 q3wk (every three weeks = one treatment cycle)
Experimental: Lurbinectedin plus Irinotecan - Patients will consecutively receive the following q3wk (every three weeks = one treatment cycle):
* Irinotecan (Day 1 and Day 8)
* Lurbinectedin (Day 1)
Active comparator: Control arm - Best Investigator's choice prior to randomization between:
* Irinotecan on Day 1 q3wk
* Topotecan on Days 1-5 q3wk
Treatment: Drugs: Irinotecan
Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk
Treatment: Drugs: Lurbinectedin
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 q3wk
Treatment: Drugs: Irinotecan
For patients aged \<70 years: irinotecan 350 mg/m² intravenously Day 1 q3wk For patients aged =70 years: irinotecan 300 mg/m² intravenously Day 1 q3wk
Treatment: Drugs: Topotecan
Topotecan 2.3 mg/m² oral or 1.5 mg/m² intravenously Days 1-5 q3wk
Treatment: Drugs: Lurbinectedin
Lurbinectedin 2.0 mg/m² will be administered intravenously on Day 1 q3wk
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival
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Assessment method [1]
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Overall survival (OS) will be calculated from the date of randomization to the date of death or last contact (in this case, survival will be censored on that date).
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Timepoint [1]
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From the date of randomization to the date of death or last contact, up to 39 months
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Secondary outcome [1]
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Progression-free survival by IRC (Independent Review Committee)
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Assessment method [1]
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Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease = 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy.
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Timepoint [1]
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From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
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Secondary outcome [2]
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Progression-free survival by IA (Investigator Assessment)
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Assessment method [2]
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Progression-free survival (PFS) will be calculated from the date of randomization to the date of documented progression per RECIST v.1.1 (Progressive disease is declared when there is an increase in sum of target disease = 20%) or death (regardless of the cause of death). If the patient receives further antitumor therapy, withdraws from the study, or is lost to follow-up before progressive disease (PD), PFS will be censored at the date of last evaluable tumor assessment before the date of subsequent antitumor therapy.
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Timepoint [2]
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From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 39 months
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Secondary outcome [3]
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Overall response rate by IRC
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Assessment method [3]
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Overall response rate (ORR) will be the percentage of patients with complete or partial response as the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease = 20%, stable disease when the change is \> -30% and = 20%, partial response when there is a decrease in sum of target disease = 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is \< 10 mm each.
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Timepoint [3]
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From the date of randomization to the date of death or last contact, up to 39 months
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Secondary outcome [4]
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Overall response rate by IA
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Assessment method [4]
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Overall response rate (ORR) will be the percentage of patients with complete or partial response as the best response obtained in any evaluation according to RECIST v.1.1. Progressive disease is declared when there is an increase in sum of target disease = 20%, stable disease when the change is \> -30% and = 20%, partial response when there is a decrease in sum of target disease = 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is \< 10 mm each.
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Timepoint [4]
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From the date of randomization to the date of death or last contact, up to 39 months
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Secondary outcome [5]
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Overall survival rate at 12 months
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Assessment method [5]
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Overall survival rate at 12 months is defined as the percentage of people who are still alive at 12 months after randomization.
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Timepoint [5]
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At 12 months
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Secondary outcome [6]
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Overall survival rate at 24 months
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Assessment method [6]
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Overall survival rate at 24 months is defined as the percentage of people who are still alive at 24 months after randomization.
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Timepoint [6]
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At 24 months
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Secondary outcome [7]
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Progression-free survival rate at 6 months by IRC
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Assessment method [7]
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Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization
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Timepoint [7]
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At 6 months
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Secondary outcome [8]
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Progression-free survival rate at 6 months by IA
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Assessment method [8]
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Progression-free survival rate at 6 months is defined as the percentage of people who remain free from progression at 6 months after randomization
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Timepoint [8]
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At 6 months
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Secondary outcome [9]
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Progression-free survival rate at 12 months by IRC
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Assessment method [9]
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Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization
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Timepoint [9]
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At 12 months
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Secondary outcome [10]
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Progression-free survival rate at 12 months by IA
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Assessment method [10]
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Progression-free survival rate at 12 months is defined as the percentage of people who remain free from progression at 12 months after randomization
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Timepoint [10]
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At 12 months
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Secondary outcome [11]
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Duration of response by IRC
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Assessment method [11]
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Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease = 20%, stable disease when the change is \> -30% and = 20%, partial response when there is a decrease in sum of target disease = 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is \< 10 mm each.
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Timepoint [11]
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From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
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Secondary outcome [12]
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Duration of response by IA
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Assessment method [12]
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Duration of response (DoR) will be calculated from the date of first documentation of response per RECIST v.1.1 (complete or partial response, whichever occurs first) to the date of documented PD or death. Progressive disease is declared when there is an increase in sum of target disease = 20%, stable disease when the change is \> -30% and = 20%, partial response when there is a decrease in sum of target disease = 30%, and complete response when all lesions have disappeared or all lesions have disappeared and all nodal disease is \< 10 mm each.
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Timepoint [12]
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From the date of first documentation of complete or partial response to the date of documented progression disease, death or last contact, up to 39 months
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Secondary outcome [13]
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Patient-reported outcomes
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Assessment method [13]
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To measure the quality of life of patients, the Lung Cancer Symptom Scale (LCSS) questionnaire will be analyzed.
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Timepoint [13]
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At baseline and every six weeks (± one week) until end of treatment, up to 39 months
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Eligibility
Key inclusion criteria
1. Voluntary written informed consent of the patient obtained before any study-specific procedure
2. Age=18 years
3. Histologically or cytologically confirmed diagnosis of SCLC.
4. One prior line of platinum-containing chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
5. Chemotherapy-free interval (CTFI, time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) = 30 days (independent of the immunotherapy maintenance, if applicable)
6. Patients with history of Central Nervous System (CNS) metastases can participate provided they are pretreated and radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeated imaging (note: repeated imaging should be performed during study screening), asymptomatic, and without requirement of steroid treatment for at least 7 days before the first dose of study treatment
7. Eastern Cooperative Oncology Group (ECOG) PS = 2
8. Adequate hematological, renal, metabolic and hepatic function:
1. Hemoglobin = 9.0 g/dL [patients may have received prior red blood cell (RBC) transfusion, if clinically indicated]; absolute neutrophil count (ANC) = 2.0 x 10^9/L, and platelet count = 100 x 10^9/L.
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3.0 x upper limit of normal (ULN).
3. Total bilirubin = 1.5 x ULN or direct bilirubin = ULN.
4. Albumin = 3.0 g/dL.
5. Calculated creatinine clearance (CrCL) = 30 mL/min (using Cockcroft and Gault's formula).
9. At least three weeks since last prior antineoplastic treatment and recovery to grade = 1 from any adverse event (AE) related to previous anticancer treatment (excluding sensory neuropathy, anemia, asthenia and alopecia, all grade = 2) according to the National Cancer InstituteCommon Terminology Criteria for Adverse Events (NCICTCAE) v.5.
10. Prior radiotherapy (RT): At least two weeks since completion of prophylactic cranial irradiation (PCI), and to any other site not previously specified.
11. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to seven months after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
2. Prior treatment with lurbinectedin, trabectedin, PM14, or topoisomerase I inhibitors (irinotecan, topotecan, etc.).
3. Active or untreated CNS metastases and/or carcinomatous meningitis.
4. Patients with limited-stage disease who are candidates for local or regional therapy, including PCI, thoracic RT or both, must have been offered that option and completed treatment or refused it prior to randomization.
5. Concomitant diseases/conditions:
1. History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
2. Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
3. Ongoing chronic alcohol consumption or cirrhosis with Child-Pugh score B or C.
4. Known Gilbert's disease.
5. Active uncontrolled infection. Serious non-healing wound, ulcer or bone fracture. Presence of external drainages.
6. Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen (HBsAg) and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. Subjects taking hepatitis related antiviral therapy within six months prior to the first dose of study drugs will also be excluded.
7. Intermittent or continuous oxygen requirement within two weeks prior to randomization. Patients with confirmed or suspected diagnosis of diffuse interstitial lung disease or pulmonary fibrosis.
8. Patients with a second invasive malignancy treated with chemotherapy and/or RT. Patients with a previous malignancy that was completely resected with curative intention three or more years prior to randomization, except treated in situ carcinoma of the cervix, basal or squamous cell skin carcinoma, and in situ transitional cell bladder carcinoma and who has been continuously in remission since then will be permitted.
9. Limitation of the patient's ability to comply with the treatment or to follow the protocol.
10. Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
11. Known human immunodeficiency virus (HIV) infection.
12. Any past or present chronic inflammatory colon and/or liver disease, past intestinal obstruction, pseudo or subocclusion or paralysis.
13. Evident symptomatic pleural or cardiac effusion rapidly increasing and/or necessitating prompt local treatment within seven days.
14. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study (e.g.; COVID-19 disease).
6. RT in more than 35% of the bone marrow.
7. History of previous bone marrow and/or stem cell transplantation and allogenic transplant.
8. Patient has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of inactivated vaccines is allowed.
9. Impending need for RT (e.g., painful bone metastasis and/or risk of spinal cord compression).
10. History of allergy or hypersensitivity to any of the study drugs or any of their excipients.
11. Women who are pregnant or breast feeding and fertile patients (men and women) who are not able to use a highly effective method of contraception
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2026
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Actual
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Sample size
Target
705
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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The Chris Obrien Lifehouse - Camperdown
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Recruitment hospital [2]
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BRICC - Ballarat Health Services - Ballarat Central
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Recruitment hospital [3]
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Box Hill Hospital Eastern Health Clinical School - Box Hill
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Recruitment hospital [4]
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Northern Beaches Hospital - Frenchs Forest
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Recruitment hospital [5]
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Gosford Hospital GH - Central Coast Cancer Centre - Gosford
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Recruitment hospital [6]
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Austin Hospital- Medical Oncology Unit - Heidelberg
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Recruitment hospital [7]
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St John of God Murdoch Hospital - Murdoch
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Recruitment hospital [8]
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Cancer Care Wollongong - Wollongong
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3350 - Ballarat Central
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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NSW 2086 - Frenchs Forest
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Recruitment postcode(s) [5]
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2250 - Gosford
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Recruitment postcode(s) [6]
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VIC 3084 - Heidelberg
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Recruitment postcode(s) [7]
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WA 6150 - Murdoch
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Recruitment postcode(s) [8]
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NSW 2500 - Wollongong
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Recruitment outside Australia
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United States of America
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Arizona
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North Carolina
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Charleroi
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Germany
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Halle
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0
Germany
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Heidelberg
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Germany
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Karlsruhe
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Germany
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Kassel
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Germany
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Löwenstein
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Germany
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Mannheim
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Germany
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München
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Germany
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Offenbach
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Hungary
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Debrecen
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Hungary
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Farkasgyepu
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Hungary
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Kecskemét
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Hungary
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Szolnok
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Hungary
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Törökbálint
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Alessandria
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Italy
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Ancona
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Italy
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Aviano
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Italy
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Bologna
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Italy
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Catania
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Italy
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Cuneo
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Italy
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Florence
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Italy
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Genova
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Italy
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Milan
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Italy
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Napoli
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Italy
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Novara
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Italy
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Orbassano
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Italy
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Padova
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Italy
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Piacenza
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Italy
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Rionero In Vulture
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Italy
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Roma
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Italy
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Siena
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Italy
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Sondrio
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Italy
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Varese
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Japan
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Aomori
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Osaka-Fu
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Poland
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Bialystok
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Poland
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Gdynia
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Poland
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Lublin
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Poland
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Prabuty
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Poland
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Rzeszów
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Poland
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Tomaszów Mazowiecki
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Poland
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Lódz
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Romania
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Baia Mare
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Ovidiu
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Romania
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Timisoara
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Gran Canaria
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Spain
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Navarra
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Spain
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Pontevedra
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Spain
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A Coruña
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Spain
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Córdoba
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Valladolid
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Spain
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Zaragoza
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Switzerland
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Basel
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Switzerland
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Bellinzona
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Switzerland
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Frauenfeld
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Switzerland
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Lausanne
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Switzerland
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Liestal
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Switzerland
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Münsterlingen
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Switzerland
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Villars-sur-Glâne
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Taiwan
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Chiayi
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Taiwan
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Chang Hua
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Istambul
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Turkey
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Kocaeli
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United Kingdom
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Belfast
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United Kingdom
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Harlow
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United Kingdom
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London
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United Kingdom
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Manchester
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Country [159]
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United Kingdom
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Nottingham
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United Kingdom
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Wirral
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Country [161]
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
PharmaMar
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.
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Trial website
https://clinicaltrials.gov/study/NCT05153239
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
0
0
José Antonio Lopez-Vilariño, MD
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Address
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0
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Country
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0
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Phone
0
0
0034 91 823 4564
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05153239
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