Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Antibodies

Gemcitabine

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Cisplatin

Cemiplimab

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

Standard-of-care chemotherapy will administered from these options:

Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance

cemiplimab regimen as monotherapy as per study protocol

Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin

Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin

Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

Patients will be administered cemiplimab as per protocol.

cemiplimab

Clinical Trial Management

The primary objectives of the study are:

* To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells
* To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells

The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies

There is option to join genomics sub-study.

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer

PFS as assessed by a blinded IRC using RECIST 1.1.

The number of patients with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of patients in the efficacy analysis set

The BOR, as determined by the IRC per RECIST 1.1

Duration of response will be defined as the time between the date of first response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy or death due to any cause, whichever comes first

Number of patients with laboratory abnormalities

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)	NCT03088540	Carcinoma，Non-S... Lung Carcinomas... Non-small-cell ... Nonsmall Cell L...	Pemetrexed Paclitaxel Gemcitabine Cisplatin Carboplatin cemiplimab	18 Years -	Regeneron Pharmaceuticals
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)	NCT03088540	Carcinoma，Non-S... Lung Carcinomas... Non-small-cell ... Nonsmall Cell L...	Pemetrexed Paclitaxel Gemcitabine Cisplatin Carboplatin cemiplimab	18 Years -	Regeneron Pharmaceuticals
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)	NCT03088540	Carcinoma，Non-S... Lung Carcinomas... Non-small-cell ... Nonsmall Cell L...	Pemetrexed Paclitaxel Gemcitabine Cisplatin Carboplatin cemiplimab	18 Years -	Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for previous smoker