Eftilagimod Alfa + Pembrolizumab + Chemotherapy for Lung Cancer

Recruiting at 39 trial locations

Overseen By Chief Scientific Officer

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Immutep S.A.S.

Must be taking: Antiretrovirals, Hepatitis antivirals

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: CNS metastases, Cardiac disease, Autoimmune, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 104 weeks

756 Participants Needed

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.

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

Group I: efti + Standard of Care arm Experimental Treatment 4 Interventions

Combination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy

Group II: Placebo + Standard of Care arm Placebo Group 4 Interventions

Combination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy

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

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

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