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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04129502
Registration number
NCT04129502
Ethics application status
Date submitted
7/10/2019
Date registered
16/10/2019
Titles & IDs
Public title
TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
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Scientific title
A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
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Secondary ID [1]
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NL20191212
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Secondary ID [2]
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TAK-788-3001
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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:
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
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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 - TAK-788
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Experimental: TAK-788 Group (Arm A) - TAK-788 160 milligram (mg) with or without food, capsules, orally, once daily until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria.
Active comparator: Platinum-based Chemotherapy Group (Arm B) - Pemetrexed 500 milligram per meter square (mg/m\^2) plus cisplatin 75 mg/m\^2, infusion, IV, once on Day 1 of 21-day cycle pemetrexed 500 mg/m\^2 plus carboplatin, infusion, IV, once at a dose calculated to produce area under curve (AUC) of 5 milligram\*minute per milliliter (mg\*min/mL) on Day 1 of 21-day cycle until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria. Pemetrexed/cisplatin or pemetrexed/carboplatin will be repeated every 3 weeks for 4 cycles, followed by maintenance treatment with pemetrexed 500 mg/m\^2, on Day 1 of a 21-day cycle thereafter.
Treatment: Drugs: TAK-788
TAK-788 capsule
Treatment: Drugs: Pemetrexed
Pemetrexed IV infusion
Treatment: Drugs: Cisplatin
Cisplatin IV infusion
Treatment: Drugs: Carboplatin
Carboplatin IV infusion
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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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Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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Assessment method [1]
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PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST Version 1.1 are met or death, whichever occurs first.
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Timepoint [1]
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Up to approximately 40 months after the first participant is randomized
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Secondary outcome [1]
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Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
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Assessment method [1]
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Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved complete response (CR) or partial response (PR). Confirmed responses are responses that persist on repeat imaging =4 weeks after initial response.
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Timepoint [1]
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Up to approximately 40 months after the first participant is randomized
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the interval from the date of randomization until death.
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Timepoint [2]
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Up to approximately 40 months after the first participant is randomized
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Secondary outcome [3]
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Progression Free Survival (PFS) as Assessed by the Investigator
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Assessment method [3]
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PFS is defined as the time interval from the date of randomization until the first date at which the criteria for PD according to RECIST Version 1.1 are met or death, whichever occurs first.
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Timepoint [3]
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0
Up to approximately 40 months after the first participant is randomized
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Secondary outcome [4]
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Confirmed Objective Response Rate (ORR) as Assessed by the Investigator
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Assessment method [4]
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Confirmed ORR is defined as the percentage of participants who are confirmed to have achieved CR or PR. Confirmed responses are responses that persist on repeat imaging =4 weeks after initial response.
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Timepoint [4]
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Up to approximately 40 months after the first participant is randomized
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Secondary outcome [5]
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Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
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Assessment method [5]
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Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD or death (whichever occurs first) is objectively documented.
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Timepoint [5]
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0
Up to approximately 40 months after the first participant is randomized
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Secondary outcome [6]
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Time to Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
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Assessment method [6]
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Time to response is defined as the time interval from the date of randomization until the initial observation of CR or PR.
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Timepoint [6]
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Up to approximately 40 months after the first participant is randomized
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Secondary outcome [7]
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Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
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Assessment method [7]
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DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks) after the initiation of study drug.
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Timepoint [7]
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Up to approximately 40 months after the first participant is randomized
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Secondary outcome [8]
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Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
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Assessment method [8]
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EORTC QLQ-C30 is a cancer-specific questionnaire which comprises of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores will be converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QoL scale, higher scores represent better HRQoL, whereas for the symptom scales lower scores represent better HRQoL (i.e., a low level of symptomatology/problems).
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Timepoint [8]
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Up to approximately 40 months after the first participant is randomized
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Secondary outcome [9]
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Participant-reported Symptoms as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Lung Cancer Module (QLQ-LC13)
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Assessment method [9]
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EORTC QLQ-LC13 is a cancer-specific questionnaire which comprises of 13 questions assessing lung cancer-associated symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and use of pain medication. Raw scores will be converted into scale scores ranging from 0 to 100. Higher scores represent a high level of symptomatology/problems.
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Timepoint [9]
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Up to approximately 40 months after the first participant is randomized
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Eligibility
Key inclusion criteria
* Male or female adult patients (aged 18 years or older)
* Histologically or cytologically confirmed nonsquamous cell locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) NSCLC
* Documented epidermal growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (US sites) or an accredited (outside of the US) local laboratory The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or human epidermal growth factor receptor 2 (HER2) mutations except EGFR mutations for which there are approved anti-EGFR tyrosine kinase inhibitors [TKIs] (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid)
* Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation
* At least 1 measurable lesion per RECIST Version 1.1
* Life expectancy =3 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Adequate organ and hematologic function as defined by blood transfusions with a recommended >/ 14 day washout period.
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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
* Received prior systemic treatment for locally advanced or metastatic disease, including local administration, such as intra-pleural injection of anticancer medication with the exception noted below:
* Neoadjuvant or adjuvant chemotherapy/immune therapy for Stage I to III or combined modality chemotherapy/radiation for locally advanced disease is allowed if completed >6 months before the development of metastatic disease.
* Received radiotherapy =14 days before randomization or has not recovered from radiotherapy-related toxicities
* Received a moderate or strong cytochrome P450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before first dose of TAK-788
* Have been diagnosed with another primary malignancy other than NSCLC
* Have current spinal cord compression or leptomeningeal disease
* Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure
* Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin
* Taking medication(s) known to be associated with the development of torsades de pointes.
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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
Active, not 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
10/01/2020
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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
30/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
354
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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Recruitment hospital [1]
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GenesisCare North Shore - St Leonards
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Recruitment hospital [2]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [3]
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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5042 - Bedford Park
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Recruitment outside Australia
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United States of America
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California
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Ukraine
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State/province [101]
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Kropyvnytskyi
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Country [102]
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United Kingdom
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State/province [102]
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London, City Of
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United Kingdom
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Surrey
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United Kingdom
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State/province [104]
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Wirral
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United Kingdom
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Leicester
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Ethics approval
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Summary
Brief summary
The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.
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Trial website
https://clinicaltrials.gov/study/NCT04129502
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Study Director
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Takeda
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
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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/NCT04129502