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Combinations of Cemiplimab (Anti-PD-1 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409614
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 10, 2018
First Posted Date  ICMJE January 24, 2018
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE March 6, 2018
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
Overall survival [ Time Frame: Up to 32 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • Progression-free survival [ Time Frame: Up to 32 months ]
  • Objective response rate [ Time Frame: Up to 32 months ]
  • Duration of Response (DOR) [ Time Frame: Up to 32 months ]
  • Best overall response (BOR) [ Time Frame: Up to 32 months ]
  • Incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 32 months ]
  • Incidence of Dose-limiting toxicities (DLTs) [ Time Frame: Up to 32 months ]
    Part 1 only
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 32 months ]
  • Incidence of deaths [ Time Frame: Up to 32 months ]
  • Incidence of laboratory abnormalities [ Time Frame: Up to 32 months ]
  • Overall survival rate [ Time Frame: 12 months ]
  • Overall survival rate [ Time Frame: 18 months ]
  • Overall survival rate [ Time Frame: 24 months ]
  • Quality of life as measured by EORTC QLQ-C30 [ Time Frame: Up to 32 months ]
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
  • Quality of life as measured by EORTC QLQ-LC13 [ Time Frame: Up to 32 months ]
    Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
  • Overall survival (OS) [ Time Frame: Up to 32 months ]
  • Objective response rate (ORR) [ Time Frame: Up to 32 months ]
  • Incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 32 months ]
  • Incidence of Dose-limiting toxicities (DLTs) [ Time Frame: Up to 32 months ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 32 months ]
  • Incidence of deaths [ Time Frame: Up to 32 months ]
  • Incidence of laboratory abnormalities [ Time Frame: Up to 32 months ]
  • Overall survival [ Time Frame: 12 months ]
  • Overall survival [ Time Frame: 18 months ]
  • 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)
  • Quality of life [ Time Frame: Up to 32 months ]
    As measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
Official Title  ICMJE A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Brief Summary

The primary objectives of this study are:

Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in <50% of tumor cells.

Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

The key secondary objectives are:

Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in <50% of tumor cells.

Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Part 1: Open label Part 2: Double blind
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: REGN2810
    REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
    Other Name: cemiplimab
  • Drug: REGN2810/chemo/ipi
    REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
    Other Name: cemiplimab
  • Other: Chemotherapy
    Platinum-based doublet chemotherapy Part 1
  • Drug: Placebo
    Matching placebo Part 2
Study Arms  ICMJE
  • Chemo
    Part 1: Chemotherapy
    Interventions:
    • Other: Chemotherapy
    • Drug: Placebo
  • Experimental: REGN2810+Chemo Part 1
    Part 1: REGN2810+chemo
    Intervention: Drug: REGN2810
  • Experimental: REGN2810+AbbrevChemo+ipi
    Part 1: REGN2810+abbrev chemo+ipi
    Intervention: Drug: REGN2810/chemo/ipi
  • Experimental: Placebo+Chemo
    Part 2: Placebo plus chemo
    Intervention: Drug: Placebo
  • Experimental: REGN2810+Chemo Part 2
    Part 2: REGN2810+chemo
    Intervention: Drug: REGN2810
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 7, 2020)
790
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
690
Estimated Study Completion Date  ICMJE May 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Men and women ≥20 years of age for Japanese patients
  2. 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
  3. 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
  4. Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially available assay performed by the central laboratory
  5. At least 1 radiographically measurable 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
  6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  7. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

  1. Part 1 only: 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. 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   China,   Czechia,   France,   Georgia,   Greece,   Ireland,   Italy,   Korea, Republic of,   Lithuania,   Malaysia,   Poland,   Romania,   Russian Federation,   Slovakia,   Thailand,   Turkey,   Ukraine,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03409614
Other Study ID Numbers  ICMJE R2810-ONC-16113
2017-001311-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP