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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase 1 Study of REGN4659 (Anti-CTLA-4 mAb) in Combination With Cemiplimab (Anti-PD-1 mAb) in the Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03580694
• Other study ID #: R4659-ONC-1795
• Status: Terminated
• Phase: Phase 1
• Start date: June 27, 2018
• Est. completion date: December 4, 2019

Study information

• Verified date: March 2020
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• REGN4659
REGN4659 will be administered by intravenous (IV) infusion.
• Cemiplimab
Cemiplimab will be administered by intravenous (IV) infusion.

Locations

Country	Name	City	State
United States	Regeneron Investigational Site	Charlotte	North Carolina
United States	Regeneron Investigational Site	Chicago	Illinois
United States	Regeneron Investigational Site	Grand Rapids	Michigan
United States	Regeneron Investigational Site	Nashville	Tennessee
United States	Regeneron Investigational Site	Oklahoma City	Oklahoma
United States	Regeneron Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of dose limiting toxicities (DLTs) during the dose escalation phase		Up to week 126
Primary	Rate of treatment emergent adverse events (TEAEs)		Up to week 126
Primary	Rate of immune-related adverse events (irAEs)		Up to week 126
Primary	Rate of serious adverse events (SAEs)		Up to week 126
Primary	Rate of deaths		Up to week 126
Primary	Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])		Up to week 126
Primary	Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during the dose expansion phase		Up to week 126
Primary	REGN4659 and cemiplimab concentrations in serum over time		Up to week 126
Secondary	ORR based on RECIST 1.1 during the dose escalation phase		Up to week 126
Secondary	ORR based on immune-based therapy Response Evaluation Criteria (iRECIST)		Up to week 126
Secondary	Best overall response (BOR)		Up to week 126
Secondary	Duration of response (DOR)		Up to week 126
Secondary	Disease control rate		Up to week 126
Secondary	Progression-free-survival (PFS) based on RECIST 1.1		Up to week 126
Secondary	PFS based on iRECIST		Up to week 126
Secondary	Overall survival (OS)		Up to week 126