Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer

NCT03777124 | Terminated Phase 2

• 1 other identifier: SHR-1210-II-214
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, multi-center, phase II trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus Pemetrexed and Carboplatin in Subjects with KRAS mutant stage IV non-squamous Non-small Cell Lung Cancer

Conditions

NSCLC Stage IV; KRAS Gene Mutation; PD-1 Antibody; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1

  PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee Using RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.

  up to approximately 40 months

Secondary Outcomes (6)

• Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

  up to approximately 40 months

• Duration of Overall Survival (OS)

  up to approximately 40 months

• Objective Response Rate (ORR)

  up to approximately 40 months

• disease control rate (DCR)

  up to approximately 40 months

• Duration of response （DoR）

  up to approximately 40 months

Study Arms (2)

SHR-1210 +apatinib

EXPERIMENTAL

subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day

Drug: SHR-1210; Drug: Apatinib

chemotherapy

ACTIVE COMPARATOR

Pemetrexed 500mg/m2, Day 1 of each 21 day, 4 cycles carboplatin AUC 5 on Day 1 of each 21 day, 4 cycles followed by pemetrexed 500mg/m2 until progression Q3W

Drug: Pemetrexed; Drug: Carboplatin

Interventions

SHR-1210 DRUG

Subjects receive SHR-1210 intravenous every 2 weeks

SHR-1210 +apatinib

Apatinib DRUG

Subjects receive Apatinib orally every day

SHR-1210 +apatinib

Pemetrexed DRUG

Subjects receive Pemetrexed intravenous every 3 weeks

chemotherapy

Carboplatin DRUG

subjects receive carboplatin intravenous every 3 weeks

chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: KRAS mutant
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histopathological diagnosis of adenocarcinoma non-small cell lung cancer (NSCLC) and clinical stage IV
• has not received prior systemic treatment for metastatic NSCLC.
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
• confirmes by the central laboratory as KRAS gene mutation
• Has archived Tumor tissue samples
• Subject must have a measurable target lesion based on RECIST v1.1 .
• Women of childbearing age must undergo a serological pregnancy test within 3 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug.
• Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

You may not qualify if:

• active brain metastases and meningeal metastasis
• uncontrollable tumor-related pain
• massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage;
• radiotherapy to lung that is \>30 Gy within 24 weeks before the first dose,
• imaging (CT or MRI) showed that the tumor invading the large vessels
• Known EGFR/ALK mutation.
• subjects with any known or suspected autoimmune diseases
• subjects with known or suspected interstitial pneumonia;
• Subjects with severe cardiovascular and cerebrovascular diseases
• arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months;
• female subjects who are pregnant or lactation or who plan to be pregnant during the study period;
• positive HIV test;
• active hepatitis B
• evidence of active TB infection within 1 year before first dose;
• severe infection occurred within 4 weeks before the first dose

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Shanghai Chest Hospital: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab; apatinib; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Jianjun Zou, MD, PhD

  Jiangsu HengRui Medicine Co., Ltd.

  STUDY DIRECTOR

• Shun Lu, MD, PhD

  Jiaotong University,Shanghai chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 17, 2018
• Study Start: July 11, 2019
• Primary Completion: June 29, 2023
• Study Completion: June 29, 2023
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

CN (1)