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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 October 2023
• Main ID: NCT03088540
• Date of registration: 03/03/2017
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
• Scientific 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
• Date of first enrolment: May 29, 2017
• Target sample size: 712
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03088540
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Belarus, Brazil, Bulgaria, Chile, China, Colombia, Czechia, Georgia, Greece, Hungary, Jordan, Lebanon, Malaysia, Mexico, Philippines, Poland, Romania, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lung Carcinomas, Non-Small-Cell

Carcinoma,Non-Small-Cell Lung

Nonsmall Cell Lung Cancer

Non-small-cell Lung Carcinoma

Intervention(s)

Drug: Carboplatin

Drug: Gemcitabine

Drug: Cisplatin

Drug: Paclitaxel

Drug: cemiplimab

Drug: Pemetrexed

Primary Outcome(s)

Progression-free survival (PFS) as assessed by a blinded Independent review committee (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]

Overall survival (OS) [Time Frame: From date of randomization until the date of death, assessed up to 68 months]

Secondary Outcome(s)

Incidence of deaths [Time Frame: Baseline up to 68 months after treatment]

Incidence of serious adverse events (SAEs) [Time Frame: Baseline up to 68 months after treatment]

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]

Incidence of Adverse Events (AEs) [Time Frame: Baseline up to 68 months after treatment]

Incidence of laboratory abnormalities [Time Frame: Baseline up to 68 months after treatment]

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]

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]

Characterize the pharmacokinetics (PK) of cemiplimab [Time Frame: Baseline up to 68 months after treatment]

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]

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]

Measure concentrations of cemiplimab in serum [Time Frame: Baseline up to 68 months after treatment]

Secondary ID(s)

2016-004407-31

R2810-ONC-1624

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi