Olomorasib for Non-Small Cell Lung Cancer

(SUNRAY-02 Trial)

Recruiting at297 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for people with a specific mutation in their lung cancer (KRAS G12C). Part A includes those who've had surgery to remove the cancer, while Part B is for those whose cancer can't be removed by surgery. Participants must meet other health requirements not specified here.

Inclusion Criteria

Contraceptive use should be consistent with local regulations for those participating in clinical studies

I can take pills by mouth.

My lung cancer diagnosis was confirmed through lab tests.

Exclusion Criteria

I have another cancer that is getting worse or was treated in the last 3 years.

I have been treated for an autoimmune disease within the last 2 years, except for hormone replacement.

I've had a severe reaction to immunotherapy or an unresolved mild reaction.

Treatment Details

Interventions

• Durvalumab (Monoclonal Antibodies)
• Olomorasib (Monoclonal Antibodies)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The study tests if Olomorasib combined with Pembrolizumab (Part A) or Durvalumab (Part B) works better than these immunotherapies alone with a placebo. It's a comparison over up to three years per participant to see which combination offers more benefits.

Participant Groups

Group I: Part B: Olomorasib + Durvalumab Experimental Treatment 2 Interventions

Participants will receive olomorasib administered orally in combination with durvalumab administered IV for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.

Group II: Part A: Olomorasib + Pembrolizumab Experimental Treatment 2 Interventions

Participants will receive olomorasib administered orally in combination with pembrolizumab intravenously (IV) for up to 1 year followed by olomorasib alone for up to 3 years of total treatment.

Group III: Part B: Placebo + Durvalumab Placebo Group 2 Interventions

Participants will receive placebo administered orally in combination with durvalumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.

Group IV: Part A: Placebo + Pembrolizumab Placebo Group 2 Interventions

Participants will receive placebo administered orally in combination with pembrolizumab administered IV for up to 1 year followed by placebo alone for up to 3 years of total treatment.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology