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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06119581




Registration number
NCT06119581
Ethics application status
Date submitted
1/11/2023
Date registered
7/11/2023

Titles & IDs
Public title
A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C
Scientific title
SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression =50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression
Secondary ID [1] 0 0
J3M-MC-JZQB
Secondary ID [2] 0 0
18612
Universal Trial Number (UTN)
Trial acronym
SUNRAY-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Neoplasm Metastasis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3537982
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Placebo
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed

Experimental: Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab - LY3537982 Dose level 1 administered orally in combination with pembrolizumab administered intravenously (IV) in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Experimental: Dose Optimization: LY3537982 Dose Level 2 plus Pembrolizumab - LY3537982 Dose level 2 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Experimental: Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and Platinum - LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Experimental: Part A: LY3537982 plus Pembrolizumab - LY3537982 administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo comparator: Part A: Placebo plus Pembrolizumab - Placebo administered orally in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Experimental: Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and Platinum - LY3537982 administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Placebo comparator: Part B: Placebo plus Pembrolizumab, Pemetrexed, and Platinum - Placebo administered orally in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.


Treatment: Drugs: LY3537982
Administered orally.

Treatment: Drugs: Pembrolizumab
Administered IV.

Treatment: Drugs: Placebo
Administered orally.

Treatment: Drugs: Cisplatin
Administered IV.

Treatment: Drugs: Carboplatin
Administered IV.

Treatment: Drugs: Pemetrexed
Administered IV.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)
Timepoint [1] 0 0
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Primary outcome [2] 0 0
Part A and Part B: Progression-Free Survival (PFS)
Timepoint [2] 0 0
Randomization to first documented progression of disease or death from any cause. (Estimated as approximately 1 year)
Secondary outcome [1] 0 0
Part A and Part B: Overall Survival (OS)
Timepoint [1] 0 0
Randomization to date of death from any cause. (Estimated as up to 3 years)
Secondary outcome [2] 0 0
Part A and Part B: Overall Response Rate (ORR): Percentage of Participants who Achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
Timepoint [2] 0 0
Randomization to disease progression or death. (Estimated as approximately 1 year)
Secondary outcome [3] 0 0
Part A and Part B: Duration of Response (DOR)
Timepoint [3] 0 0
Date of first evidence of CR or PR to date of disease progression or death from any cause. (Estimated as approximately 1 year)
Secondary outcome [4] 0 0
Part A and Part B: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)
Timepoint [4] 0 0
Randomization to disease progression or death from any cause. (Estimated as approximately 1 year)
Secondary outcome [5] 0 0
Part A and Part B: Time to Response (TTR)
Timepoint [5] 0 0
Time from randomization until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 1 year)
Secondary outcome [6] 0 0
Part A and Part B: PFS2
Timepoint [6] 0 0
Randomization to disease progression on next line of treatment or death from any cause (Estimated as approximately 1 year
Secondary outcome [7] 0 0
Part A and Part B: Time to Worsening of NSCLC-related Symptoms as Measured by NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ)
Timepoint [7] 0 0
Randomization through end of treatment (Estimated as approximately 1 year)
Secondary outcome [8] 0 0
Part A and Part B: Time to Deterioration in Physical Function, as Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning Subscale
Timepoint [8] 0 0
Randomization through end of treatment (Estimated as approximately 1 year)
Secondary outcome [9] 0 0
Part A and Part B: Proportion of Time with High Side-Effect Burden, as Measured by Functional Assessment of Cancer Therapy - General Item 5 (FACT-GP5)
Timepoint [9] 0 0
Randomization through end of treatment (Estimated as approximately 1 year)
Secondary outcome [10] 0 0
Part A and Part B: Change from Baseline in Overall Health-related Quality of Life, as Measured by the EORTC QLQ-C30 Global Health Status/Quality of Life Subscale
Timepoint [10] 0 0
Randomization through end of treatment (Estimated as approximately 1 year)

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
* Must have disease with evidence of KRAS G12C mutation.
* Must have known programmed death-ligand 1 (PD-L1) expression

* Part A: Greater than or equal to (=)50 percent (%).
* Part B: 0% to 100%.
* Must have measurable disease per RECIST v1.1.
* Must have an ECOG performance status of 0 or 1.
* Estimated life expectancy =12 weeks.
* Ability to swallow capsules.
* Must have adequate laboratory parameters.
* Contraceptive use should be consistent with local regulations for those participating in clinical studies.
* Women of childbearing potential must

* Have a negative pregnancy test.
* Not be breastfeeding during treatment and after study intervention for at least 180 days.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3.
* Have had any of the following prior to randomization:

-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.

--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:
* Have known active central nervous system metastases and/or carcinomatous meningitis.

Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)

* Squamous cell and/or mixed small cell/nonsmall cell histology is not permitted.
* Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
* Is unable or unwilling to take folic acid or vitamin B12 supplementation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2029
Actual
Sample size
Target
1016
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
Mackay Base Hospital - Mackay
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 0 0
The Townsville Hospital - Townsville
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Ballarat Health Services - Ballarat Central
Recruitment hospital [9] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [10] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [11] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
4740 - Mackay
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
4814 - Townsville
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [9] 0 0
3065 - Melbourne
Recruitment postcode(s) [10] 0 0
3630 - Shepparton
Recruitment postcode(s) [11] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Massachusetts
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Michigan
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Minnesota
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New Jersey
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New Mexico
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New York
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Oregon
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Vorarlberg
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Wien
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Belgium
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Antwerpen
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Brabant Wallon
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Namur
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Ronse
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Bahia
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Ceará
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Distrito Federal
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Maranhão
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Yichang
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Praha 8
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Aquitaine
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Hauts-de-Seine
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Ille-et-Vilaine
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Languedoc-Roussillon
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France
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Rhône
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Baden-Württemberg
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Germany
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Bayern
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Schleswig-Holstein
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Germany
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Thüringen
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Berlin
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Hamburg
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Greece
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Acha?a
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Greece
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Attikí
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Irakleío
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Bács-Kiskun
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Pest
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Budapest
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Delhi
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Kerala
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Maharashtra
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Odisha
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India
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Tamil Nadu
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India
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Telangana
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Uttar Pradesh
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India
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Chandigarh
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India
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Puducherry
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Campania
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Puglia
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Roma
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Bologna
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Padova
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Varese
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Aichi
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Chiba
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Ehime
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Hokkaido
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Hyogo
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Ishikawa
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Kanagawa
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Miyagi
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Niigata
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Osaka
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Saitama
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Shizuoka
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Tokyo
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Tottori
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Yamaguchi
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Fukuoka
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Kyoto
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Okayama
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Wakayama
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Seoul-teukbyeolsi [Seoul]
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Korea, Republic of
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Seoul-teukbyeolsi
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Korea, Republic of
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Taegu-Kwangyokshi
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Mexico
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Querétaro
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Puebla
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Veracruz
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Netherlands
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Fryslân
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Noord-Brabant
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Overijssel
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Zuid-Holland
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Utrecht
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Akershus
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Buskerud
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Hordaland
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Oppland
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Rogaland
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Sør-Trøndelag
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Norway
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Oslo
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Kujawsko-pomorskie
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Portugal
State/province [171] 0 0
Coimbra
Country [172] 0 0
Portugal
State/province [172] 0 0
Porto
Country [173] 0 0
Romania
State/province [173] 0 0
Bucuresti
Country [174] 0 0
Romania
State/province [174] 0 0
Cluj
Country [175] 0 0
Romania
State/province [175] 0 0
Constan?a
Country [176] 0 0
Romania
State/province [176] 0 0
Dolj
Country [177] 0 0
Romania
State/province [177] 0 0
Timi?
Country [178] 0 0
Romania
State/province [178] 0 0
Bucure?ti
Country [179] 0 0
Spain
State/province [179] 0 0
A Coruña [La Coruña]
Country [180] 0 0
Spain
State/province [180] 0 0
A Coruña [
Country [181] 0 0
Spain
State/province [181] 0 0
Balears [Baleares]
Country [182] 0 0
Spain
State/province [182] 0 0
Barcelona [Barcelona]
Country [183] 0 0
Spain
State/province [183] 0 0
Castilla Y León
Country [184] 0 0
Spain
State/province [184] 0 0
Catalunya [Cataluña]
Country [185] 0 0
Spain
State/province [185] 0 0
Cádiz
Country [186] 0 0
Spain
State/province [186] 0 0
Las Palmas
Country [187] 0 0
Spain
State/province [187] 0 0
Madrid, Comunidad De
Country [188] 0 0
Spain
State/province [188] 0 0
Madrid
Country [189] 0 0
Spain
State/province [189] 0 0
Navarra
Country [190] 0 0
Spain
State/province [190] 0 0
Valenciana, Comunitat
Country [191] 0 0
Spain
State/province [191] 0 0
Badajoz
Country [192] 0 0
Spain
State/province [192] 0 0
Málaga
Country [193] 0 0
Spain
State/province [193] 0 0
Sevilla
Country [194] 0 0
Sweden
State/province [194] 0 0
Södermanlands Län [se-04]
Country [195] 0 0
Sweden
State/province [195] 0 0
Västmanlands Län [se-19]
Country [196] 0 0
Switzerland
State/province [196] 0 0
Vaud
Country [197] 0 0
Switzerland
State/province [197] 0 0
Winterthur
Country [198] 0 0
Switzerland
State/province [198] 0 0
Zürich
Country [199] 0 0
Taiwan
State/province [199] 0 0
Hualien
Country [200] 0 0
Taiwan
State/province [200] 0 0
Kaohsiung
Country [201] 0 0
Taiwan
State/province [201] 0 0
Taichung
Country [202] 0 0
Taiwan
State/province [202] 0 0
Tainan
Country [203] 0 0
Taiwan
State/province [203] 0 0
Taipei
Country [204] 0 0
Taiwan
State/province [204] 0 0
Yunlin
Country [205] 0 0
Taiwan
State/province [205] 0 0
Changhua
Country [206] 0 0
Taiwan
State/province [206] 0 0
Chiayi
Country [207] 0 0
Taiwan
State/province [207] 0 0
Taoyuan
Country [208] 0 0
Turkey
State/province [208] 0 0
Adana
Country [209] 0 0
Turkey
State/province [209] 0 0
Ankara
Country [210] 0 0
Turkey
State/province [210] 0 0
Antalya
Country [211] 0 0
Turkey
State/province [211] 0 0
Bursa
Country [212] 0 0
Turkey
State/province [212] 0 0
Diyarbakir
Country [213] 0 0
Turkey
State/province [213] 0 0
Istanbul
Country [214] 0 0
Turkey
State/province [214] 0 0
Izmir
Country [215] 0 0
Turkey
State/province [215] 0 0
Kocaeli
Country [216] 0 0
Turkey
State/province [216] 0 0
Samsun
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Aberdeen City
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Dundee City
Country [219] 0 0
United Kingdom
State/province [219] 0 0
England
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Gloucestershire
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Hillingdon
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Withington
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Leeds
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Loxo Oncology, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT06119581