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

NCT04619433 | Terminated Phase 3

• 1 other identifier: SHR-1210-III-324
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Non-squamous Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (9)

• Part 1：Serum concentrations of Camrelizumab

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 1：Plasma concentrations of Famitinib

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 1：Area Under the Plasma Concentration Versus Time Curve (AUC) of Famitinib.

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 1：Maximum Concentration (Cmax) of Famitinib.

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 1：Time to Maximum Concentration (Tmax) of Famitinib.

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 1：Half-life (t1/2 z) of Famitinib.

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 1：Apparent Clearance (CL/F) of Famitinib

  Cycle 2; each cycle is 21 days (up to 42 days）

• Part 1：Vz/F of Famitinib.

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 2: Progression-free Survival (PFS) as Assessed by BICR according to RECIST 1.1.

  up to 24 months

Secondary Outcomes (10)

• Part 1:Objective Response Rate (ORR) as Assessed by investigators

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 1:Duration of Response (DOR) as Assessed by investigators

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 1:Progression-free Survival (PFS) as Assessed by investigators

  Cycle 2; each cycle is 21 days (up to 42 days)

• Part 1:Overall Survival (OS).

  Up to approximately 60 months

• Part 2:Overall Survival (OS)

  Up to approximately 60 months

Study Arms (2)

Treatment group A

EXPERIMENTAL

Intervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib

Drug: Camrelizumab;Pemetrexed and Carboplatin; Famitinib;

Treatment group B

PLACEBO COMPARATOR

Intervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo

Drug: Camrelizumab;Pemetrexed and Carboplatin;Placebo

Interventions

Camrelizumab;Pemetrexed and Carboplatin; Famitinib; DRUG

Part 1: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib

Also known as: SHR1210

Treatment group A

Camrelizumab;Pemetrexed and Carboplatin;Placebo DRUG

Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo

Also known as: SHR1210

Treatment group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form, male or female, 18-70 years of age.
• Histologically or cytologically confirmed, Stage IIIB-IV non-squamous NSCLC
• EGFR mutation and ALK rearrangement status must be negative.
• No prior system chemotherapy for advanced/metastatic NSCLC.
• Measurable diseaseas defined by RECIST v1.1.
• ECOG performance status of 0 or 1.
• Has a life expectancy of at least 3 months.
• Adequater organ function.
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, and be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug; Male subjects with partners of childbearing potential must either be surgically sterilized or agree to take effective contraceptive measures during the study and within 3 months after the last dose of the study drug.

You may not qualify if:

• Other histological types of non-small cell lung cancer.
• Subjects with carcinomatous meningitis and spinal cord compression.
• Subjects with untreated central nervous system (CNS) metastasis.
• Subjects who can be treated with surgical resection or radical radiotherapy.
• Subjects who previously received anti-PD-1(L1) or CTLA4 monoclonal antibody, VEGF or VEGFR signaling pathway single target/multiple target inhibitor or monoclonal antibodies.
• \. Medical history and complications
• Subjects with any active, known, or suspected autoimmune diseases.
• Subjects who require systemic corticosteroids prednisone (\> 10 mg/day or equivalent) or other immunosuppressants within 14 days prior to the first dose.
• Subjects who received cancer vaccines or other immunostimulatory anti-cancer agents (interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to the first dose.
• Subjects who received anti-cancer TCM within 14 days prior to the first dose.
• Subjects who are in another clinical study or last participated (last dose) in a clinical study less than 4 weeks (or 5 half-lives of the study drug) from the first dose, whichever is shorter.
• Subjects who are expected to require other forms of anti-cancer treatment during the study.
• Subjects who received major surgery within 4 weeks prior to the first dose, non-thoracic radiation therapy \> 30 Gy within 4 weeks prior to the first dose, thoracic radiation therapy \> 30 Gy within 24 weeks prior to the first dose, or palliative radiation ≤ 30 Gy within 2 weeks prior to the first dose, and failed to recover from the toxicities and/or complications of these interventions to NCI-CTC AE Grade ≤ 1 (except for alopecia and fatigue). Palliative radiotherapy for symptomatic control is permitted, but must be completed within 2 weeks prior to starting the study treatment.
• Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe lung diseases that seriously affect pulmonary function.
• Subjects with a history of malignant tumors.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (7)

Beijing Cancer Hosipital

Beijing, Beijing Municipality, 100089, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Hubei Cancer Hospita

Wuhan, Hubei, 430079, China

Location

Shengjing Hospita of China Medical University

Shenyang, Liaoning, 110022, China

Location

Shanghai Lung Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, 610000, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Interventions

Carboplatin; famitinib; camrelizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1210 in combination with Famitinib plus chemotherapy.

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 6, 2020
• Study Start: February 1, 2021
• Primary Completion: August 16, 2025
• Study Completion: August 16, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

CN (7)