Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C) (NCT04956640) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
United States, Australia, Canada540 participantsStarted 2021-07-19
Plain-language summary
The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
* Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA).
* Participants must have a histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Have adequate organ function.
* Have discontinued all previous treatments for cancer with resolution of any significant ongoing adverse events (AEs), (except in certain scenarios).
* Must be able to swallow capsule/tablet.
* Agree and adhere to contraceptive use, if applicable.
* For some parts of the study, (i.e., one of the two arms with LY3537982 in combination with pembrolizumab and the arm of LY3537982 in combination with pembrolizumab, pemetrexed, and platinum therapy) histologically or cytologically confirmed Stage IIIB-IIIC or Stage IV NSCLC that is previously untreated in the advanced/metastatic setting and not suitable for curative intent radical surgery or radiation therapy. Previously untreated patients who received adjuvant and neoadjuvant therapy are eligible if the last dose of the systemic treatment was completed at least 6 months prior to enrollment. For untreated patients in the arm with LY3537982 in combination with pembrolizumab noted above, a sing…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My cancer has a KRAS G12C mutation — based on my specific cancer type, like NSCLC, colorectal, or pancreatic cancer, which part of this trial might even be worth discussing for my situation, and does the combination treatment being tested match where I am in my treatment history?
2Since this is a Phase 1/Phase 2 trial that's no longer recruiting new patients, is there any possibility of still joining, or are there other KRAS G12C-targeted trials currently open that I should be looking into instead?
3For the combinations being studied here — like LY3537982 with pembrolizumab for lung cancer, or with cetuximab for colorectal cancer — what do we know so far about the safety profile, and how does that compare to what I'd face with standard treatment options?
4Because this trial is still in early phases and focused partly on finding the right dose, how much uncertainty does that mean there is about both the effectiveness and the risks of LY3537982, and how should that factor into my decision compared to proven standard-of-care options?
5If my cancer is pancreatic with a KRAS G12C mutation, where this trial was specifically looking at the drug on its own, what would you say are the realistic odds of benefit at this stage, and what other treatment paths should we be weighing at the same time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy
Timeframe: Cycle 1 (21 Days)
2
Phase 1b: To assess the safety and tolerability of LY3537982 when administered alone or in combination with other investigational agents
Timeframe: Cycle 1 (21 Days)
3
Phase 1b: To determine the optimal dose of LY3537982 to be administered to treatment-naïve participants with advanced NSCLC in combination with pembrolizumab
Timeframe: Estimated up to 2 years
4
To determine the optimal dose of LY3537982 to be administered to participants who have received at least one prior oxaliplatin- or irinotecan-containing regimen for advanced or metastatic CRC in combination with cetuximab
Timeframe: Estimated up to 2 years
5
To assess the antitumor activity of LY3537982 monotherapy in participants with advanced pancreatic cancer with KRAS G12C mutation