TerminatedPhase 1NCT03580694

Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

The objective of this trial is to study REGN4659 and cemiplimab in treatment-experienced, non-small cell lung cancer (NSCLC) patients. There are 2 phases of this study: a dose escalation phase and a dose expansion phase.

Checked against the public recordLast updated Mar 13, 2020 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1
U.S. locations6
SponsorRegeneron Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Regeneron Pharmaceuticals
Interventions being studied
Drug: REGN4659; Drug: Cemiplimab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

KEY Inclusion Criteria: 1. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with unresectable stage IIIB or stage IV disease 2. Combination dose escalation cohorts: Treatment-experienced patients who have received no more than 3 lines of systemic therapy including no more than 2 lines of cytotoxic chemotherapy, and for whom no available therapy has a high probability to convey clinical benefit. 3. Dose escalation cohort C: Anti-PD-1/PD-L1 naïve patients who have received 1 to 2 prior lines of cytotoxic chemotherapy including a platinum doublet-containing regimen 4. Expansion cohort(s): Anti-PD-1/PD-L1 experienced patients who have progressed while receiving therapy or within 6 months of stopping therapy for stage III or IV disease. Patients must not have permanently discontinued anti-PD-1/PD-L1 therapy due to treatment related AE. Patients must have received one line of anti-PD--1/PD-L1 immunotherapy. Patients may also have received one line of chemotherapy KEY Exclusion Criteria: 1. Expansion cohort(s) only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime 2. Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy 3. Expansion cohort(s) only: Patients with tumors tested positive for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) gene mutations or ROS1 fusions. 4. Radiation therapy within 2 weeks prior to enrollment and not recovered to baseline from any AE due to radiation 5. Patients who received prior treatment with an anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody 6. Previous treatment with idelalisib (ZYDELIG®) at any time Note: Other protocol defined inclusion/ exclusion criteria apply

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Regeneron Investigational SiteChicago, Illinois
  • Regeneron Investigational SiteGrand Rapids, Michigan
  • Regeneron Investigational SiteCharlotte, North Carolina
  • Regeneron Investigational SiteOklahoma City, Oklahoma
  • Regeneron Investigational SiteNashville, Tennessee
  • Regeneron Investigational SiteSan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 13, 2020. Always confirm current availability with the study team.

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