A Study to Evaluate SHR-1210 in Combination With Famitinib Plus Chemotherapy in Subjects With NSCLC.

Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Study ID: NCT04619433
Phase: PHASE3
Status: Terminated

Conditions

Non-squamous Non-small-cell Lung Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - 70 Years
Healthy Volunteers: Not accepted

Interventions

Camrelizumab;Pemetrexed and Carboplatin; Famitinib; — DRUG
Part 1: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib
Camrelizumab;Pemetrexed and Carboplatin;Placebo — DRUG
Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo

Study Details

The study is being conducted to evaluate the efficacy and safety of SHR-1210 in combination with Famitinib plus chemotherapy in subjects with NSCLC.

Key Dates

Start date: Feb 1, 2021
Status verified: Sep 2025
Primary completion: Aug 16, 2025
Completion: Aug 16, 2025

Study Design

Enrollment: 48 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Treatment group A
Intervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib
Placebo Comparator: Treatment group B
Intervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo

Primary Outcome Measure

Part 1：Serum concentrations of Camrelizumab [ Time Frame: Cycle 2; each cycle is 21 days (up to 42 days) ]