Ramucirumab + Erlotinib for Lung Cancer

(RELAY Trial)

Recruiting at 171 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?

This trial is testing a new drug combination to treat patients with advanced lung cancer who have specific genetic changes. The treatment aims to stop cancer growth by cutting off its blood supply and blocking growth signals. One of the drugs being tested has shown significant survival benefits when combined with other treatments in advanced lung cancer.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 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 type of advanced lung cancer (Stage IV NSCLC) that has not been treated before and has certain EGFR mutations. Participants must have a life expectancy of at least 3 months, one measurable lesion, and provide tissue samples. It's not for those with certain medical conditions like significant bleeding disorders or recent major blood vessel invasion by cancer.

Inclusion Criteria

You are expected to live for at least 3 more months.

You are able to receive erlotinib as your first treatment if your tumor has certain mutations in the EGFR gene.

You need to provide tissue samples from your lung cancer. If you don't have stage IV lung cancer, other tissue samples may be accepted.

Exclusion Criteria

You have been taking nonsteroidal anti-inflammatory drugs for more than 2 months.

You have a history of coughing up a lot of blood.

There are visible holes inside the tumor on the imaging tests.

Treatment Details

Interventions

• Erlotinib (Tyrosine Kinase Inhibitor)
• Gefitinib (Tyrosine Kinase Inhibitor)
• Osimertinib (Tyrosine Kinase Inhibitor)
• Placebo (Other)
• Ramucirumab (Monoclonal Antibodies)

Trial Overview The study tests the effectiveness and safety of Ramucirumab combined with Erlotinib versus placebo combined with Erlotinib in treating lung cancer. Part C extends to test Ramucirumab with Gefitinib or Osimertinib in East Asian participants based on disease progression and mutation status.

Participant Groups

Group I: Ramucirumab + Gefitinib or Osimertinib Experimental Treatment 3 Interventions

Part C: 10 mg/kg ramucirumab administered every 2 weeks intravenously (IV) + 250 mg Gefitinib or 80 mg Osimertinib daily orally. * Ramucirumab and gefitinib administered during period 1. * Ramucirumab and osimertinib administered during period 2.

Group II: Ramucirumab + Erlotinib Experimental Treatment 2 Interventions

Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

Group III: Placebo + Erlotinib Placebo Group 2 Interventions

Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

Erlotinib is already approved in Canada for the following indications:

Approved in Canada as Tarceva for:

• Non-small cell lung cancer
• Pancreatic cancer

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