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Monoclonal Antibodies

Immunotherapy Combinations for Lung Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Servier Bio-Innovation LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adult patient aged ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until study termination (approximately 3 years)
Awards & highlights

Summary

"This trial is testing a new drug called cemiplimab, combined with other antibodies, in adults with advanced non-small cell lung cancer who have not been treated before. The study has two parts

Who is the study for?
Adults with advanced or metastatic non-small cell lung cancer (NSCLC) that hasn't been treated before can join this trial. They should be in good physical condition, have a certain level of PD-L1 expression in their tumors, and not be candidates for surgery or definitive chemoradiation.
What is being tested?
The study is testing the effectiveness of cemiplimab combined with one of three other drugs: S095018, S095024, or S095029. These combinations are being evaluated to find the safest and most effective doses for treating NSCLC with high PD-L1 expression.
What are the potential side effects?
Potential side effects may include immune-related reactions due to anti-PD1 therapy like skin issues, digestive problems, liver inflammation, hormonal gland changes; infusion reactions; fatigue; and possible increased risk of infections.

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 restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My lung cancer is advanced and cannot be removed by surgery or cured with radiation and chemotherapy.
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I haven't had any systemic treatment for my advanced lung cancer.
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My cancer has a high PD-L1 level (50% or more).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until study termination (approximately 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and until study termination (approximately 3 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of dose-limiting toxicities (DLTs) during the first 2 cycles of combination treatment
Secondary study objectives
6-month Durable Response (6-month DR)
Adverse Events (AEs) Leading to Dose Interruption, Modification, or Delays
Adverse Events (AEs) Leading to Permanent Treatment Discontinuation
+13 more

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: S095029 (anti-NKG2A antibody) in combination with cemiplimabExperimental Treatment2 Interventions
Part A: Combination-therapy safety lead-in
Group II: S095029 (anti-NKG2A antibody) RDE in combination with cemiplimabExperimental Treatment2 Interventions
Part B: Randomized dose expansion
Group III: S095024 (anti-CD73 antibody) in combination with cemiplimabExperimental Treatment2 Interventions
Part A: Combination-therapy safety lead-in
Group IV: S095024 (anti-CD73 antibody) RDE in combination with cemiplimabExperimental Treatment2 Interventions
Part B: Randomized dose expansion
Group V: S095018 (anti-TIM3 antibody) in combination with cemiplimabExperimental Treatment2 Interventions
Part A: Combination-therapy safety lead-in
Group VI: S095018 (anti-TIM3 antibody) RDE in combination with cemiplimabExperimental Treatment2 Interventions
Part B: Randomized dose expansion
Group VII: Cemiplimab (control arm)Active Control1 Intervention
Part B: Randomized dose expansion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
647 Previous Clinical Trials
384,042 Total Patients Enrolled
Servier Bio-Innovation LLCLead Sponsor
8 Previous Clinical Trials
576 Total Patients Enrolled
Institut de Recherches Internationales ServierOTHER
89 Previous Clinical Trials
66,938 Total Patients Enrolled
~117 spots leftby Apr 2027
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