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

NCT ID: NCT03580694

Last Updated: 2020-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-27
• Study Completion Date: 2019-12-04

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cemiplimab Monotherapy

In a single dose escalation cohort, participants will receive cemiplimab alone.

Group Type: EXPERIMENTAL

Cemiplimab

Intervention Type: DRUG

Cemiplimab will be administered by intravenous (IV) infusion.

Combination Therapy

Dose Escalation cohorts:

In 3 dose escalation cohorts, participants will receive a lead-in dose of REGN4659 followed by REGN4659 and cemiplimab in combination.

In 4 dose escalation cohorts, participants will receive REGN4659 with cemiplimab in combination.

Dose Expansion cohorts:

In dose expansion cohorts, participants will receive combination regimens of REGN4659 and cemiplimab.

Group Type: EXPERIMENTAL

REGN4659

Intervention Type: DRUG

REGN4659 will be administered by intravenous (IV) infusion.

Cemiplimab

Intervention Type: DRUG

Cemiplimab will be administered by intravenous (IV) infusion.

Interventions

REGN4659

REGN4659 will be administered by intravenous (IV) infusion.

Intervention Type: DRUG

Cemiplimab

Cemiplimab will be administered by intravenous (IV) infusion.

Intervention Type: DRUG

Other Intervention Names

REGN2810

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Investigational Site

Chicago, Illinois, United States

Regeneron Investigational Site

Grand Rapids, Michigan, United States

Regeneron Investigational Site

Charlotte, North Carolina, United States

Regeneron Investigational Site

Oklahoma City, Oklahoma, United States

Regeneron Investigational Site

Nashville, Tennessee, United States

Regeneron Investigational Site

San Antonio, Texas, United States

Countries

United States

Other Identifiers

R4659-ONC-1795

Identifier Type: -

Identifier Source: org_study_id