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

NCT ID: NCT03777124

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2023-06-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SHR-1210 +apatinib

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

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

Subjects receive SHR-1210 intravenous every 2 weeks

Apatinib

Intervention Type: DRUG

Subjects receive Apatinib orally every day

chemotherapy

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

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

Subjects receive Pemetrexed intravenous every 3 weeks

Carboplatin

Intervention Type: DRUG

subjects receive carboplatin intravenous every 3 weeks

Interventions

SHR-1210

Subjects receive SHR-1210 intravenous every 2 weeks

Intervention Type: DRUG

Apatinib

Subjects receive Apatinib orally every day

Intervention Type: DRUG

Pemetrexed

Subjects receive Pemetrexed intravenous every 3 weeks

Intervention Type: DRUG

Carboplatin

subjects receive carboplatin intravenous every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects with histopathological diagnosis of adenocarcinoma non-small cell lung cancer (NSCLC) and clinical stage IV

2. has not received prior systemic treatment for metastatic NSCLC.

3. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status

4. confirmes by the central laboratory as KRAS gene mutation

5. Has archived Tumor tissue samples

6. Subject must have a measurable target lesion based on RECIST v1.1 .

7. 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.

8. Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Exclusion Criteria

1. active brain metastases and meningeal metastasis

2. uncontrollable tumor-related pain

3. massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage;

4. radiotherapy to lung that is >30 Gy within 24 weeks before the first dose,

5. imaging (CT or MRI) showed that the tumor invading the large vessels

6. Known EGFR/ALK mutation.

7. subjects with any known or suspected autoimmune diseases

8. subjects with known or suspected interstitial pneumonia;

9. Subjects with severe cardiovascular and cerebrovascular diseases

10. arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months;

11. female subjects who are pregnant or lactation or who plan to be pregnant during the study period;

12. positive HIV test;

13. active hepatitis B

14. evidence of active TB infection within 1 year before first dose;

15. severe infection occurred within 4 weeks before the first dose

16. patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month

17. subjects who is on systemic immunogenic agents;

18. a history of severe allergic reactions to other monoclonal antibodies/fusion proteins;

19. History of severe allergic reactions to carboplatin or pemetrexed or their preventive drugs;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianjun Zou, MD, PhD

Role: STUDY_DIRECTOR

Jiangsu HengRui Medicine Co., Ltd.

Shun Lu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jiaotong University,Shanghai chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHR-1210-II-214

Identifier Type: -

Identifier Source: org_study_id