Clinical trial • Phase III • Oncology
LY3537982 for Non-small cell lung cancer (KRAS G12C-mutant)
Phase III trial of LY3537982 for Non-small cell lung cancer (KRAS G12C-mutant).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer (KRAS G12C-mutant)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 29-01-2025
- First CTIS Authorization Date
- 20-05-2025
Trial design
Randomised, part a: olomorasib (ly3537982) + pembrolizumab versus placebo + pembrolizumab; part b: olomorasib (ly3537982) + durvalumab versus placebo + durvalumab (doses and schedules not specified in source).-controlled Phase III trial in France, Sweden, Greece and others.
- Randomised
- Yes
- Comparator
- Part A: olomorasib (LY3537982) + pembrolizumab versus placebo + pembrolizumab; Part B: olomorasib (LY3537982) + durvalumab versus placebo + durvalumab (doses and schedules not specified in source).
- Biomarker Stratified
- True, KRAS G12C mutation and PD-L1 expression (strata not specified)
- Target Sample Size
- 437
Eligibility
Recruits 437 No vulnerable populations selected (isVulnerablePopulationSelected: false)..
- Pregnancy Exclusion
- Women of childbearing potential must • Have a negative pregnancy test. • Not be breastfeeding during treatment
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false).
Inclusion criteria
- {"criterion_text":"- Histological or cytological confirmation of NSCLC. • Part A a. Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible. b. Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection. • Part B – Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy. • Must have disease with evidence of KRAS G12C mutation."}
- {"criterion_text":"- Must have known programmed death-ligand 1 (PD-L1) expression"}
- {"criterion_text":"- Must have an ECOG performance status of 0 or 1."}
- {"criterion_text":"- Able to swallow oral medication."}
- {"criterion_text":"- Must have adequate laboratory parameters."}
- {"criterion_text":"- Contraceptive use should be consistent with local regulations for those participating in clinical studies."}
- {"criterion_text":"- Women of childbearing potential must • Have a negative pregnancy test. • Not be breastfeeding during treatment"}
Exclusion criteria
- {"criterion_text":"- Have known changes in the EGFR or ALK genes."}
- {"criterion_text":"- Have another type of cancer that is progressing or required active treatment within the past 3 years before screening."}
- {"criterion_text":"- Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed."}
- {"criterion_text":"- Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Part A: Disease-free survival by investigator assessment Part B: PFS by BICR","definition_or_measurement_approach":"Part A measured as disease-free survival by investigator assessment; Part B measured as progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)."}
Recruitment
- Digital Remote Recruitment
- True, third-party vendors listed in trial documents (e.g., Medable Inc., Reify Health Inc., Veeva Systems Inc., Tempus Compass LLC) indicate use of digital platforms and vendor-supported remote recruitment/tracking/data solutions (roles shown in sponsor third-party list include 'Recruitment Tracking' and vendor support).
- Planned Sample Size
- 437
- Recruitment Window Months
- 81
- Consent Approach
- Informed consent obtained using Main ICF Part A and Part B; country-specific ICFs and addenda are provided (multiple language/country versions present, e.g., GR, PT, SE, NO, NL, DE/AT, ES, PL, IT, CZ, HU, SK and others). Participants provide their own consent (no paediatric/assent procedures indicated).
Methods
- Doctor referral letters — channel: letter to physicians; target audience: referring doctors; country-specific versions available (document titles include Letter-Doctor-Referral with country suffixes).
- Posters — channel: clinic/poster materials; target audience: potential patient participants; country-specific poster materials referenced.
- Trial awareness brochures / Trial brochure — channel: printed brochure; target audience: patients and caregivers; country-specific versions referenced.
- Visit cards / Patient contact cards — channel: printed cards given at sites; target audience: patients; country-specific versions referenced.
- List of participating sites — channel: published site list for referral; target audience: healthcare professionals and patients.
- Study guides / Study guide parts A and B — channel: informational materials for participants; target audience: enrolled or potential participants.
- Recruitment tracking vendor support — channel: digital/vendor-supported tracking (documents reference recruitment tracking and vendors).
Geography
- Total Number Of Sites
- 110
- Total Number Of Participants
- 271
France
- Earliest CTIS Part Ii Submission Date
- 02-05-2025
- Latest Decision Or Authorization Date
- 21-05-2025
- Processing Time Days
- 19
- Number Of Sites
- 16
- Number Of Participants
- 41
Sweden
- Earliest CTIS Part Ii Submission Date
- 22-04-2025
- Latest Decision Or Authorization Date
- 21-05-2025
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 9
Greece
- Earliest CTIS Part Ii Submission Date
- 10-02-2025
- Latest Decision Or Authorization Date
- 20-05-2025
- Processing Time Days
- 99
- Number Of Sites
- 8
- Number Of Participants
- 11
Austria
- Earliest CTIS Part Ii Submission Date
- 27-04-2025
- Latest Decision Or Authorization Date
- 26-05-2025
- Processing Time Days
- 29
- Number Of Sites
- 3
- Number Of Participants
- 8
Hungary
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 26-05-2025
- Processing Time Days
- 59
- Number Of Sites
- 3
- Number Of Participants
- 6
Netherlands
- Earliest CTIS Part Ii Submission Date
- 09-05-2025
- Latest Decision Or Authorization Date
- 28-05-2025
- Processing Time Days
- 19
- Number Of Sites
- 7
- Number Of Participants
- 17
Norway
- Earliest CTIS Part Ii Submission Date
- 06-05-2025
- Latest Decision Or Authorization Date
- 20-05-2025
- Processing Time Days
- 14
- Number Of Sites
- 5
- Number Of Participants
- 10
Portugal
- Earliest CTIS Part Ii Submission Date
- 17-04-2025
- Latest Decision Or Authorization Date
- 21-05-2025
- Processing Time Days
- 34
- Number Of Sites
- 4
- Number Of Participants
- 8
Czechia
- Earliest CTIS Part Ii Submission Date
- 24-03-2025
- Latest Decision Or Authorization Date
- 20-05-2025
- Processing Time Days
- 57
- Number Of Sites
- 2
- Number Of Participants
- 4
Italy
- Earliest CTIS Part Ii Submission Date
- 10-02-2025
- Latest Decision Or Authorization Date
- 23-05-2025
- Processing Time Days
- 102
- Number Of Sites
- 10
- Number Of Participants
- 37
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-04-2025
- Latest Decision Or Authorization Date
- 21-05-2025
- Processing Time Days
- 34
- Number Of Sites
- 4
- Number Of Participants
- 11
Romania
- Earliest CTIS Part Ii Submission Date
- 10-02-2025
- Latest Decision Or Authorization Date
- 26-05-2025
- Processing Time Days
- 105
- Number Of Sites
- 4
- Number Of Participants
- 10
Slovakia
- Earliest CTIS Part Ii Submission Date
- 28-04-2025
- Latest Decision Or Authorization Date
- 23-05-2025
- Processing Time Days
- 25
- Number Of Sites
- 3
- Number Of Participants
- 6
Spain
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 22-05-2025
- Processing Time Days
- 69
- Number Of Sites
- 18
- Number Of Participants
- 55
Germany
- Earliest CTIS Part Ii Submission Date
- 17-04-2025
- Latest Decision Or Authorization Date
- 14-07-2025
- Processing Time Days
- 88
- Number Of Sites
- 19
- Number Of Participants
- 32
Poland
- Earliest CTIS Part Ii Submission Date
- 06-05-2025
- Latest Decision Or Authorization Date
- 25-05-2025
- Processing Time Days
- 19
- Number Of Sites
- 3
- Number Of Participants
- 6
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research LLC
- Responsibilities
- sponsorDuties codes present (see sponsor third-party duties); specific duties not fully detailed in source JSON
- Name
- Icon Clinical Research Limited
- Responsibilities
- Training (as listed in sponsor duties)
- Name
- Iqvia Rds Inc.
- Responsibilities
- roles listed in sponsor third-party entries (codes present); specific textual responsibilities not provided
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties code 10 (role indicated in sponsor entries)
Third parties
- {"country":"United States","full_name":"Tier 1 Impact Pbc Inc.","duties_or_roles":"Training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Evidera Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"Recruitment Tracking","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"CQ Fluency, Inc.","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Clinical Trial Reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Precision for Medicine","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"Printed Study Supplies/Recruitment and Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Training","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"Negotiation and Execution of Clinical trial agreements with the participating sites, make study payments based on invoices","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Tempus Compass LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"QIAGEN Manchester Limited","duties_or_roles":"","organisation_type":"Industry"}
Investigational products
- Investigational Product Name
- Olomorasib (LY3537982)
- Active Substance
- LY3537982
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Investigational (non-authorised investigational medicinal product for trial)
- Investigational Product Name
- Pembrolizumab
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorized (marketed) - comparator immunotherapy
- Investigational Product Name
- Durvalumab
- Active Substance
- DURVALUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorized (marketed) - comparator immunotherapy
- Investigational Product Name
- Placebo to match LY
- Modality
- Other
- Combination Treatment
- Yes
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