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790 Participants Needed

Immunotherapy + Chemotherapy for Non-Small Cell Lung Cancer

Recruiting at 124 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Brain metastases, EGFR mutations, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression. The key secondary objectives are: Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) who haven't had systemic treatment for metastatic or recurrent disease. Participants must have a performance status indicating they can care for themselves and an expected lifespan of at least 3 months. They should not be candidates for chemoradiation, have measurable lesions, and specifically in Part 1, less than 50% PD-L1 tumor expression.

Inclusion Criteria

In the first part of the study, if a test shows that less than 50% of your tumor cells have a protein called PD-L1, you will not be able to participate.

I am a Japanese patient and I am 20 years old or older.

I have stage IIIB, IIIC, or IV NSCLC and haven't had specific treatments for it.

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Exclusion Criteria

You have smoked fewer than 100 cigarettes in your entire life.

I have had lung conditions like fibrosis or inflammation in the past 5 years.

I have an autoimmune disease treated with immune-suppressing drugs.

See 4 more

Treatment Details

Interventions

Cemiplimab
Chemotherapy
Placebo

Trial OverviewThe study tests combinations of Cemiplimab (an anti-PD-1 antibody) with chemotherapy against platinum-based doublet chemotherapy alone. It aims to see if these combinations improve overall survival and slow down the progression of NSCLC compared to standard chemo, considering different levels of PD-L1 expression in tumors.

Participant Groups

5Treatment groups

Experimental Treatment

Group I: REGN2810+Chemo Part 2Experimental Treatment1 Intervention

Part 2: REGN2810+chemo

Group II: REGN2810+Chemo Part 1Experimental Treatment1 Intervention

Part 1: REGN2810+chemo

Group III: REGN2810+AbbrevChemo+ipiExperimental Treatment1 Intervention

Part 1: REGN2810+abbrev chemo+ipi

Group IV: Placebo+ChemoExperimental Treatment1 Intervention

Part 2: Placebo plus chemo

Group V: ChemoExperimental Treatment2 Interventions

Part 1: Chemotherapy

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

Approved in European Union as Libtayo for:

Cutaneous squamous cell carcinoma (CSCC)
Non-small cell lung cancer (NSCLC)

Approved in United States as Libtayo for:

Cutaneous squamous cell carcinoma (CSCC)
Basal cell carcinoma (BCC)
Non-small cell lung cancer (NSCLC)

Approved in Canada as Libtayo for:

Cutaneous squamous cell carcinoma (CSCC)
Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

Cutaneous squamous cell carcinoma (CSCC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

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