Eftilagimod Alfa + Pembrolizumab + Chemotherapy for Lung Cancer

Recruiting at 125 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with advanced non-small cell lung cancer that has spread and cannot be treated surgically. The researchers aim to determine if adding eftilagimod alfa (an experimental treatment) to the standard treatment of pembrolizumab (an immune therapy) and chemotherapy improves survival and slows cancer progression compared to a placebo. Participants will receive either the new combination or a placebo, along with standard treatment, for up to two years. Eligible participants have non-small cell lung cancer that has not been treated with systemic therapy and lack certain genetic changes in their tumors. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you require other cancer treatments or have certain medical conditions. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of eftilagimod alfa (efti) and pembrolizumab is generally well-tolerated by patients with lung cancer. In earlier studies, patients with advanced or spreading non-small cell lung cancer (NSCLC) who received efti and pembrolizumab experienced manageable side effects. These studies found the treatment to be well-tolerated, with no unexpected safety problems.

One study indicated that the treatment might help fight tumors, offering promise for those who do not respond to some immune treatments. While side effects can occur with any treatment, data suggests that efti plus pembrolizumab has a safety profile that patients handled well in past trials. This evidence is encouraging for those considering participation in the current study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about eftilagimod alfa because it offers a unique approach by acting as an immune booster, enhancing the body's own defense system against lung cancer. Unlike traditional treatments that mainly target the cancer cells directly, eftilagimod alfa works by activating immune cells, potentially leading to a more robust and sustained immune response. Additionally, when combined with pembrolizumab, a well-known immunotherapy, and chemotherapy, this treatment could enhance effectiveness against tumors that are difficult to treat with standard chemotherapy alone. This novel combination has the potential to improve outcomes for patients with lung cancer beyond what current treatments can offer.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that eftilagimod alfa (efti) could be beneficial when combined with pembrolizumab and chemotherapy for treating non-small cell lung cancer (NSCLC). In this trial, one group of participants will receive a combination of efti, pembrolizumab, and histology-based platinum doublet chemotherapy. Earlier studies demonstrated that combining efti with pembrolizumab led to tumor shrinkage in 60.8% of patients, meaning more than half experienced smaller tumors. Additionally, many patients had stable or improved disease, which is a positive outcome. Another study found that efti was generally well-tolerated and helped halt tumor growth in patients unresponsive to other treatments. These findings suggest that efti might be a valuable addition to standard NSCLC therapies. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/OA-24-00102

Eftilagimod Alpha Plus Pembrolizumab in First-Line ... This phase II study investigated efti plus pembrolizumab treatment in patients with first-line metastatic non–small cell lung cancer (NSCLC) ...

2. jtocrr.org jtocrr.org/article/S2666-3643(24)00095-X/fulltext

Eftilagimod Alpha (a Soluble LAG-3 Protein) Combined ... Efti plus pembrolizumab was well-tolerated and revealed signs of antitumor activity in patients with NSCLC resistant to PD-(L)1 inhibitors, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06726265

NCT06726265 | Study of Eftilagimod Alfa (Efti) in ... The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with ...

4. jto.org jto.org/article/S1556-0864(25)00326-0/fulltext

TACTI-004: A double-blinded, randomized phase III trial ... TACTI-004 is a double-blinded, randomized, placebo-controlled phase III study testing E + SoC vs. placebo + SoC in 1L NSCLC patients (pts).

5. onclive.com onclive.com/view/first-line-eftilagimod-alpha-plus-pembrolizumab-chemo-yields-responses-in-advanced-nonsquamous-nsclc

First-Line Eftilagimod Alpha Plus Pembrolizumab/Chemo ... Eftilagimod alpha combined with pembrolizumab and chemotherapy showed high efficacy in first-line NSCLC treatment, with ORR of 60.8% and DCR of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11472608/

Eftilagimod Alpha (a Soluble LAG-3 Protein) Combined With ... Efti plus pembrolizumab was well-tolerated and revealed signs of antitumor activity in patients with NSCLC resistant to PD-(L)1 inhibitors.