ClinicalTrials.gov
ClinicalTrials.gov Menu

REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03409614
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective is to compare the progression-free survival (PFS) of cemiplimab plus platinum-based doublet chemotherapy combination therapy (cemiplimab/chemo) and cemiplimab plus platinum-based doublet chemotherapy plus ipilimumab combination therapy (cemiplimab/chemo/ipi) with standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) in the subgroup of patients whose tumors express programmed cell death ligand 1 (PD-L1) in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells.

The key secondary objectives are:

  • To compare the Overall Survival (OS) of cemiplimab/chemo and cemiplimab/chemo/ipi versus standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC in the subgroup of patients whose tumors express PD-L1 in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells
  • To compare the ORR of cemiplimab/chemo and cemiplimab/chemo/ipi versus standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC in the subgroup of patients whose tumors express PD-L1 in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells
  • To evaluate the safety and tolerability of cemiplimab/chemo and cemiplimab/chemo/ipi compared to standard-of-care platinum-based doublet chemotherapy

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: REGN2810 Drug: REGN2810/chemo/ipi Other: Chemotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 3, Open-label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 <50%
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : July 18, 2022
Estimated Study Completion Date : July 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Chemo
Chemotherapy
Other: Chemotherapy
Platinum-based doublet chemotherapy

Experimental: Dose 1
REGN2810/chemo
Drug: REGN2810
plus Platinum-based doublet chemotherapy
Other Name: cemiplimab

Experimental: Dose 2
Drug: REGN2810/abbrev chemo/ipi
Drug: REGN2810/chemo/ipi
REGN 2810 plus abbreviated chemotherapy plus Ipilimumab
Other Name: cemiplimab




Primary Outcome Measures :
  1. PFS as assessed by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessments [ Time Frame: Up to 32 months ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 32 months ]
  2. Objective response rate (ORR) [ Time Frame: Up to 32 months ]
  3. Incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 32 months ]
  4. Incidence of Dose-limiting toxicities (DLTs) [ Time Frame: Up to 32 months ]
  5. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 32 months ]
  6. Incidence of deaths [ Time Frame: Up to 32 months ]
  7. Incidence of laboratory abnormalities [ Time Frame: Up to 32 months ]
  8. Overall survival [ Time Frame: 12 months ]
  9. Overall survival [ Time Frame: 18 months ]
  10. Quality of life [ Time Frame: Up to 32 months ]
    As measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  11. Quality of life [ Time Frame: Up to 32 months ]
    As measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC
  2. Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which has not previously been irradiated
  3. Expression of PD-L1 in <50% of tumor cells determined by the commercially available assay performed by the central laboratory
  4. At least 1 radiographically measureable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
  5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  6. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

  1. Patients who 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 Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions
  4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment
  5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years
  6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs)
  7. Previous treatment with idelalisib at any time (ZYDELIG®)
  8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409614


Contacts
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

  Show 27 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03409614     History of Changes
Other Study ID Numbers: R2810-ONC-16113
2017-001311-36 ( EudraCT Number )
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Regeneron Pharmaceuticals:
Stage IIIB
Stage IIIC
Stage IV
Non-squamous NSCLC
Squamous NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies
Immunologic Factors
Physiological Effects of Drugs