What side effects are associated with this type of intervention?

Common treatments for cancer, including those similar to LY3537982 (KRAS G12C inhibitor), often involve a combination of targeted therapies, immunotherapies, and chemotherapies. Known side effects of these treatments can include fatigue, nausea, diarrhea, rash, decreased appetite, and hyperglycemia. Specific targeted therapies, such as those inhibiting the PI3K pathway or AKT1 mutations, may also cause skin toxicities and gastrointestinal issues. Immunotherapies can lead to immune-related adverse events, while chemotherapies are associated with myelosuppression, neuropathy, and increased risk of infections. Managing these side effects is crucial for maintaining the quality of life and treatment adherence in cancer patients.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for cancer treatment, including KRAS G12C inhibitors. One notable example is sotorasib (Lumakras), which was approved for the treatment of non-small cell lung cancer (NSCLC) with the KRAS G12C mutation. Other targeted therapies include EGFR inhibitors like erlotinib and gefitinib, and ALK inhibitors such as crizotinib and alectinib. These drugs work by targeting specific genetic mutations or proteins involved in cancer growth, offering more personalized and effective treatment options for patients.

What other types of research exist?

Promising alternatives to LY3537982 for cancer patients include: 1) Pembrolizumab plus chemotherapy, which has shown efficacy in metastatic non-small-cell lung cancer (NSCLC) without driver mutations. 2) Atezolizumab, an anti-PD-L1 therapy, for first-line treatment of metastatic NSCLC. 3) Farnesyltransferase inhibitors like tipifarnib for HRAS mutant squamous cell carcinoma of the head and neck. 4) MEK inhibitors such as RO4987655 for cancers with RAS-RAF mutations. These alternatives have demonstrated potential in clinical trials and may be considered in consultation with a healthcare provider.

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LY3537982 + Immunotherapy/Chemotherapy for Non-Small Cell Lung Cancer (SUNRAY-01 Trial)

Phase 3

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women of childbearing potential must have a negative pregnancy test

Ability to swallow capsules

Must not have

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

Squamous cell and/or mixed small cell/nonsmall cell histology is not permitted for participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to date of death from any cause. (estimated as up to 3 years)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug, LY3537982, combined with standard treatments for patients with advanced lung cancer that have a specific genetic mutation. The goal is to see if this combination works better than the usual treatments alone.

Who is the study for?

This trial is for adults with advanced Non-Small Cell Lung Cancer (NSCLC) that has a specific KRAS G12C gene change. They should have measurable disease, expect to live at least 12 weeks, be able to swallow pills, and not be on breastfeeding. Women who can have children must test negative for pregnancy and agree to use birth control. People with certain other cancer genes or brain metastases, those who can't stop taking NSAIDs, or had prior treatment for NSCLC (except one cycle), cannot join.

What is being tested?

The study tests if LY3537982 combined with standard cancer drugs like Pembrolizumab and chemotherapy (Cisplatin or Carboplatin plus Pemetrexed) works better than the standard care alone in treating NSCLC with KRAS G12C mutation. Some participants will also receive a placebo instead of LY3537982.

What are the potential side effects?

Possible side effects include reactions related to immune system activation by Pembrolizumab such as inflammation in various organs, infusion-related symptoms from chemotherapy agents like nausea and fatigue, blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am capable of becoming pregnant and have a negative pregnancy test.

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I can swallow pills.

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My lung cancer is mainly non-squamous.

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My cancer has a KRAS G12C mutation.

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My lung cancer is at an advanced stage and cannot be cured with surgery or radiation.

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My cancer has been tested for PD-L1 expression.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has a specific genetic change that can be targeted with treatment.

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My lung cancer is not squamous or mixed small cell/non-small cell type.

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I have cancer that has spread to my brain or spinal cord.

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I cannot stop taking aspirin or NSAIDs.

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I cannot or will not take folic acid or vitamin B12 supplements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to date of death from any cause. (estimated as up to 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to date of death from any cause. (estimated as up to 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to date of death from any cause. (estimated as up to 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE)

Part A and Part B: Progression-Free Survival (PFS)

Secondary study objectives

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

Part A and Part B: Changes in NSCLC-related symptoms as measured by NSCLC-SAQ

Part A and Part B: Changes 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 and IL19

+11 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Safety Lead In: LY3537982 plus Pembrolizumab, Pemetrexed and PlatinumExperimental Treatment5 Interventions

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.

Group II: Part B: LY3537982 plus Pembrolizumab, Pemetrexed, and PlatinumExperimental Treatment5 Interventions

Group III: Part A: LY3537982 plus PembrolizumabExperimental Treatment2 Interventions

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

Group IV: Dose Optimization: LY3537982 Dose Level 2 plus PembrolizumabExperimental Treatment2 Interventions

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.

Group V: Dose Optimization: LY3537982 Dose Level 1 plus PembrolizumabExperimental Treatment2 Interventions

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.

Group VI: Part B: Placebo plus Pembrolizumab, Pemetrexed, and PlatinumPlacebo Group5 Interventions

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.

Group VII: Part A: Placebo plus PembrolizumabPlacebo Group2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

LY3537982

2023

Completed Phase 1

~130

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550

Cisplatin

2013

Completed Phase 3

~3120

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as KRAS G12C inhibitors like LY3537982, block specific mutated proteins that promote cancer cell growth. Immunotherapies boost the immune system's ability to detect and kill cancer cells. Chemotherapy uses drugs to destroy rapidly dividing cells, including cancer cells. These mechanisms are crucial for tailoring treatment to the cancer's unique genetic and molecular profile, potentially improving outcomes and minimizing side effects.

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