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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SUNRAY-01 Trial Summary

This trial tests a drug combo to treat advanced lung cancer with a KRAS gene change. Participation could last up to 3 years.

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.Check my eligibility

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.See study design

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.

SUNRAY-01 Trial 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.

SUNRAY-01 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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: Disease Control Rate (DCR): Percentage of Participants who Achieve a BOR of CR, PR, or Stable Disease (SD)

Part A and Part B: Duration of Response (DOR)

+7 more

SUNRAY-01 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

LY3537982

2023

Completed Phase 1

~100

Pembrolizumab

2017

Completed Phase 2

~2010

Carboplatin

2014

Completed Phase 3

~6670

Pemetrexed

2014

Completed Phase 3

~5250

Cisplatin

2013

Completed Phase 3

~1940

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,215,583 Total Patients Enrolled

Loxo Oncology, Inc.Industry Sponsor

66 Previous Clinical Trials

8,853 Total Patients Enrolled

Study DirectorEli Lilly and Company

14 Previous Clinical Trials

6,026 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what locality is this experiment being conducted?

"This trial is currently being conducted in a total of 216 medical facilities. These centres are located all over the United States, such as Merced, Hollywood and Miami. It is advised that interested participants choose their closest site to limit travelling if they decide enrolling."

Answered by AI

Is there still an opportunity for volunteers to participate in this research endeavor?

"As per the database hosted on clinicaltrials.gov, this particular medical study is not currently looking for participants. This trial was first posted in March of 2024 and last updated in November 2023. However, there are 2000 other studies actively seeking enrolment at present."

Answered by AI

What objectives are being sought through this research endeavor?

"According to the clinical trial sponsor, Eli Lilly and Company, this study is measuring Progression-Free Survival (PFS) as its primary outcome across a time span of approximately one year. Multiple secondary outcomes are also being monitored including Overall Response Rate (ORR), Duration of Response (DOR) and Disease Control Rate (DCR). These figures will be determined using RECIST v1.1 by BICR."

Answered by AI

Has the combination of LY3537982 Dose Level 1 and Pembrolizumab been verified for use by the FDA?

"Multiple studies have been conducted to ascertain the safety of Dose Optimization: LY3537982 Dose Level 1 plus Pembrolizumab, thus earning it a rating of 3 on our scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06119581.

All > Non Small Cell Lung Cancer > Tucson