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

Primary Purpose

Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pemetrexed

Paclitaxel

Gemcitabine

Cisplatin

Carboplatin

cemiplimab

About this trial

This is an interventional treatment trial for Carcinoma，Non-Small-Cell Lung focused on measuring Previous Smoker, Current Smoker, Stage IIIB, Stage IIIC, Stage IV, PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

A patient must meet the following criteria to be eligible for inclusion in the study:

Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
At least 1 radiographically measureable lesion per RECIST 1.1
ECOG performance status of ≤1
Anticipated life expectancy of at least 3 months
Adequate organ and bone marrow function

Key Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

Patients that have never smoked, defined as smoking <100 cigarettes in a lifetime
Active or untreated brain metastases or spinal cord compression
Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions
Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to randomization
Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
Another malignancy that is progressing or requires treatment
Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
Active infection requiring systemic therapy within 14 days prior to randomization
Prior therapy with anti-PD 1 or anti-PD L1
Treatment-related immune-mediated AEs from immune-modulatory agents
Receipt of an investigational drug or device within 30 days
Receipt of a live vaccine within 30 days of planned start of study medication
Major surgery or significant traumatic injury within 4 weeks prior to first dose
Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
Pregnant or breastfeeding women
Women of childbearing potential or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard-of-care chemotherapy

cemiplimab

Arm Description

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

Outcomes

Primary Outcome Measures

Overall survival (OS)

Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1

PFS as assessed by a blinded IRC using RECIST 1.1.

Secondary Outcome Measures

Objective response rates (ORR)

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

Best overall response (BOR)

The BOR, as determined by the IRC per RECIST 1.1

Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies

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

Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13)

Incidence of Adverse Events (AEs)

Incidence of serious adverse events (SAEs)

Incidence of deaths

Incidence of laboratory abnormalities

Number of patients with laboratory abnormalities

Measure concentrations of cemiplimab in serum

Maximum Plasma Concentration [Cmax]

Characterize the pharmacokinetics (PK) of cemiplimab

Area Under the Curve [AUC]

Full Information

NCT ID

NCT03088540

First Posted

March 3, 2017

Last Updated

October 20, 2023

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03088540

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 29, 2017 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

There is option to join genomics sub-study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma, Nonsmall Cell Lung Cancer

Keywords

Previous Smoker, Current Smoker, Stage IIIB, Stage IIIC, Stage IV, PD-L1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

712 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard-of-care chemotherapy

Arm Type

Active Comparator

Arm Description

Arm Title

cemiplimab

Arm Type

Experimental

Arm Description

cemiplimab regimen as monotherapy as per study protocol

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Administered with either Pemetrexed, Paclitaxel or gemcitabine.

Intervention Type

Drug

Intervention Name(s)

cemiplimab

Other Intervention Name(s)

REGN2810, Libtayo

Intervention Description

Patients will be administered cemiplimab as per protocol.

Primary Outcome Measure Information:

Title

Overall survival (OS)

Time Frame

From date of randomization until the date of death, assessed up to 68 months

Title

Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1

Description

PFS as assessed by a blinded IRC using RECIST 1.1.

Time Frame

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months

Secondary Outcome Measure Information:

Title

Objective response rates (ORR)

Description

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

Time Frame

From date of randomization to the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first, up to 68 months

Title

Best overall response (BOR)

Description

The BOR, as determined by the IRC per RECIST 1.1

Time Frame

From date of randomization until the date of first documented progression or the date of subsequent anti-cancer therapy, whichever came first, assessed up to 68 months

Title

Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies

Description

Time Frame

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months

Title

Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Time Frame

Baseline up to 26 months after treatment

Title

Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13)

Time Frame

Baseline up to 26 months after treatment

Title

Incidence of Adverse Events (AEs)

Time Frame