A study of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in patients with lung cancer

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. Men and women =18 years of age.
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. The histologic diagnosis of MSCLC may be confirmed by a central laboratory.
3. Availability of an archival (=5 months) or on-study obtained formalin-fixed, paraffinembedded
tumor tissue sample from a metastatic/recurrent site, which has not previously
been irradiated.
4. Part 1 only : Expression of PD-L1 in <50% of tumor cells determined by the commercially available
assay performed by the central laboratory.
5. At least 1 radiographically measureable 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. ECOG performance status of =1.
7. Anticipated life expectancy of at least 3 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 585
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

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. 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 (see exclusion criteria 7) for details
on timing of discontinuation of steroids).
3. Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations,
or ROS1 fusions. All patients will have tumor evaluated for EGFR mutations, ALK
rearrangement, and ROS1 fusions confirmed by a central laboratory
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. A history of radiation pneumonitis in the radiation field is permitted as long as
pneumonitis resolved =6months prior to enrollment.
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). The following are not exclusionary:
vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only
hormone replacement, or psoriasis that does not require systemic treatment.
7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or
equivalent) within 14 days of randomization. Physiologic replacement doses are allowed
even if they are >10 mg of prednisone/day or equivalent, as long as they are not being
administered for immunosuppressive intent. Inhaled or topical steroids are permitted,
provided that they are not for treatment of an autoimmune disorder.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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Updated 3/21/2022