756 Participants Needed

Eftilagimod Alfa + Pembrolizumab + Chemotherapy for Lung Cancer

Recruiting at 39 trial locations
CS
Overseen ByChief Scientific Officer
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Immutep S.A.S.
Must be taking: Antiretrovirals, Hepatitis antivirals
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) among adults with metastatic non-small cell lung cancer (NSCLC).Participants will receive either efti plus standard treatment (pembrolizumab and platinum doublet chemotherapy) or placebo plus standard treatment and will be treated for up to 2 years.

Eligibility Criteria

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who haven't had systemic therapy for it. They must have a performance status indicating they can carry out daily activities, provide a tumor tissue sample, and expect to live more than 3 months. Participants should agree to contraception guidelines and not be pregnant or breastfeeding.

Inclusion Criteria

I am willing to sign a consent form and follow the study rules.
I will follow the trial's contraception rules and not donate sperm.
My doctor expects me to live more than 3 months.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either efti plus standard treatment (pembrolizumab and chemotherapy) or placebo plus standard treatment for up to 2 years

Up to 104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

  • Eftilagimod Alfa
Trial Overview The study tests eftilagimod alfa (efti) combined with pembrolizumab and chemotherapy versus a placebo combo in treating NSCLC. The goal is to see if efti improves overall survival and slows disease progression compared to the standard treatment alone.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: efti + Standard of Care armExperimental Treatment4 Interventions
Combination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
Group II: Placebo + Standard of Care armPlacebo Group4 Interventions
Combination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immutep S.A.S.

Lead Sponsor

Trials
15
Recruited
2,600+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security