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Soluble LAG-3 Fusion Protein

Eftilagimod Alpha + Pembrolizumab for Non-Small Cell Lung Cancer (TACTI-002 Trial)

Phase 2

Waitlist Available

Research Sponsored by Immutep S.A.S.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0-1

Part C (2nd line PD-X naive HNSCC): Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies after failure of prior platinum-based therapy

Must not have

Receives continuous systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to cycle 1 day 1. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease

For Part B (2nd line, PD-X refractory NSCLC): Symptomatic ascites or pleural effusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if eftilagimod alpha can help pembrolizumab work better against non-small cell lung carcinoma and head and neck carcinoma.

Who is the study for?

This trial is for adults with certain types of lung or head and neck cancer. For lung cancer, it's for those who haven't had treatment before or whose first treatment didn't work. For head and neck cancer, it's after the first treatment fails. Participants must be in good physical condition (ECOG 0-1) and not have specific genetic mutations, recent high-dose lung radiation, multiple past treatments, active brain metastases without stability post-treatment, or a history of severe immune-related side effects from similar drugs.

What is being tested?

The trial tests combining Eftilagimod alpha with Pembrolizumab to see if they're safe together and work well against non-small cell lung carcinoma (NSCLC) that can't be surgically removed or has spread elsewhere (metastatic), as well as recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

What are the potential side effects?

Possible side effects include reactions at the injection site, fatigue, nausea, skin rash, itching, joint pain; more serious ones could involve the immune system attacking normal organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My throat cancer has returned or spread and cannot be cured with surgery or other treatments.

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My NSCLC didn't respond to initial treatments including PD-1/PD-L1 inhibitors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on high doses of steroids or other immune-weakening medicines.

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I have fluid buildup in my abdomen or around my lungs and it's causing symptoms.

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My NSCLC is positive for EGFR mutation or ALK gene fusion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: HNSCCExperimental Treatment2 Interventions

Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9). Pembrolizumab: 200 mg every 3 weeks.

Group II: 2nd line NSCLCExperimental Treatment2 Interventions

Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9). Pembrolizumab: 200 mg every 3 weeks.

Group III: 1st line NSCLCExperimental Treatment2 Interventions

Eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9). Pembrolizumab: 200 mg every 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 6Eligibility criteria met