Description:
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
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
R2810-ONC-1624
- SECONDARY ID:
2016-004407-31
- NCT ID:
NCT03088540
Conditions
- Carcinoma,Non-Small-Cell Lung
- Lung Carcinomas, Non-Small-Cell
- Non-small-cell Lung Carcinoma
- Nonsmall Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Pemetrexed | | Standard-of-care chemotherapy |
Paclitaxel | | Standard-of-care chemotherapy |
Gemcitabine | | Standard-of-care chemotherapy |
Cisplatin | | Standard-of-care chemotherapy |
Carboplatin | | Standard-of-care chemotherapy |
cemiplimab | REGN2810, Libtayo | cemiplimab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Standard-of-care chemotherapy | Active Comparator | 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 | - Pemetrexed
- Paclitaxel
- Gemcitabine
- Cisplatin
- Carboplatin
|
cemiplimab | Experimental | cemiplimab regimen as monotherapy as per study protocol | |
Eligibility Criteria
Key Inclusion Criteria:
A patient must meet the following criteria to be eligible for inclusion in the study:
1. 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
2. Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent
site, which has not previously been irradiated
3. Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC
performed by the central laboratory
4. At least 1 radiographically measureable lesion per RECIST 1.1
5. ECOG performance status of ≤1
6. Anticipated life expectancy of at least 3 months
7. Adequate organ and bone marrow function
Key Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
1. Patients that have never smoked, defined as smoking <100 cigarettes in a lifetime
2. Active or untreated brain metastases or spinal cord compression
3. Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations,
or ROS1 fusions
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
5. 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
6. Patients with active, known, or suspected autoimmune disease that has required
systemic therapy in the past 2 years
7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or
equivalent) within 14 days of randomization
8. Another malignancy that is progressing or requires treatment
9. Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus
(HIV) or diagnosis of immunodeficiency
10. Active infection requiring systemic therapy within 14 days prior to randomization
11. Prior therapy with anti-PD 1 or anti-PD L1
12. Treatment-related immune-mediated AEs from immune-modulatory agents
13. Receipt of an investigational drug or device within 30 days
14. Receipt of a live vaccine within 30 days of planned start of study medication
15. Major surgery or significant traumatic injury within 4 weeks prior to first dose
16. Documented allergic or acute hypersensitivity reaction attributed to antibody
treatments
17. Known psychiatric or substance abuse disorder that would interfere with participation
with the requirements of the study, including current use of any illicit drugs
18. Pregnant or breastfeeding women
19. 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | From date of randomization until the date of death, assessed up to 68 months |
Safety Issue: | |
Description: | PFS as assessed by a blinded IRC using RECIST 1.1. |
Secondary Outcome Measures
Measure: | Objective response rates (ORR) |
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 |
Safety Issue: | |
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 |
Measure: | Best overall response (BOR) |
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 |
Safety Issue: | |
Description: | The BOR, as determined by the IRC per RECIST 1.1 |
Measure: | Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies |
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 |
Safety Issue: | |
Description: | 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 |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Baseline up to 68 months after treatment |
Safety Issue: | |
Description: | |
Measure: | Incidence of serious adverse events (SAEs) |
Time Frame: | Baseline up to 68 months after treatment |
Safety Issue: | |
Description: | |
Measure: | Incidence of deaths |
Time Frame: | Baseline up to 68 months after treatment |
Safety Issue: | |
Description: | |
Measure: | Incidence of laboratory abnormalities |
Time Frame: | Baseline up to 68 months after treatment |
Safety Issue: | |
Description: | Number of patients with laboratory abnormalities |
Measure: | Measure concentrations of cemiplimab in serum |
Time Frame: | Baseline up to 68 months after treatment |
Safety Issue: | |
Description: | Maximum Plasma Concentration [Cmax] |
Measure: | Characterize the pharmacokinetics (PK) of cemiplimab |
Time Frame: | Baseline up to 68 months after treatment |
Safety Issue: | |
Description: | Area Under the Curve [AUC] |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
- Previous Smoker
- Current Smoker
- Stage IIIB
- Stage IIIC
- Stage IV
- PD-L1
Last Updated
August 17, 2021