Clinical Trials /

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

NCT03409614

Description:

The primary objectives of this study are: Part 1: To evaluate the objective response rate (ORR) 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) 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. Part 2: To compare the overall survival (OS) and progression-free survival (PFS) 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 objective is: Part 2: To compare the 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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: R2810-ONC-16113
  • SECONDARY ID: 2017-001311-36
  • NCT ID: NCT03409614

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
REGN2810cemiplimabREGN2810+Chemo Part 1
REGN2810/chemo/ipicemiplimabREGN2810+AbbrevChemo+ipi
PlaceboChemo

Purpose

The primary objectives of this study are: Part 1: To evaluate the objective response rate (ORR) 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) 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. Part 2: To compare the overall survival (OS) and progression-free survival (PFS) 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 objective is: Part 2: To compare the 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.

Trial Arms

NameTypeDescriptionInterventions
ChemoOtherPart 1: Chemotherapy
  • Placebo
REGN2810+Chemo Part 1ExperimentalPart 1: REGN2810+chemo
  • REGN2810
REGN2810+AbbrevChemo+ipiExperimentalPart 1: REGN2810+abbrev chemo+ipi
  • REGN2810/chemo/ipi
Placebo+ChemoExperimentalPart 2: Placebo plus chemo
  • Placebo
REGN2810+Chemo Part 2ExperimentalPart 2: REGN2810+chemo
  • REGN2810

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:ORR
Time Frame:Up to 32 months
Safety Issue:
Description:Part 1 Primary Part 2 Secondary

Secondary Outcome Measures

Measure:Incidence of Treatment-emergent adverse events (TEAEs)
Time Frame:Up to 32 months
Safety Issue:
Description:
Measure:Incidence of Dose-limiting toxicities (DLTs)
Time Frame:Up to 32 months
Safety Issue:
Description:
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Up to 32 months
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:Up to 32 months
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Up to 32 months
Safety Issue:
Description:
Measure:Overall survival
Time Frame:12 months
Safety Issue:
Description:Part 2
Measure:Overall survival
Time Frame:18 months
Safety Issue:
Description:Part 2
Measure:Overall survival
Time Frame:24 months
Safety Issue:
Description:Part 2
Measure:Quality of life as measured by EORTC QLQ-C30
Time Frame:Up to 32 months
Safety Issue:
Description:European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Measure:Quality of life as measured by EORTC QLQ-LC13
Time Frame:Up to 32 months
Safety Issue:
Description:Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • Stage IIIB
  • Stage IIIC
  • Stage IV
  • Non-squamous NSCLC
  • Squamous NSCLC

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