Clinical trial NCT03777124: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC Stage IV
KRAS Gene Mutation
PD-1 Antibody
Chemotherapy Effect
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Chest Hospital
First posted: 2018-12-17
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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;

Primary outcomes:
measure: Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
timeFrame: up to approximately 40 months
Secondary outcomes:
measure: Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
timeFrame: up to approximately 40 months
measure: Duration of Overall Survival (OS)
timeFrame: up to approximately 40 months
measure: Objective Response Rate (ORR)
timeFrame: up to approximately 40 months
measure: disease control rate (DCR)
timeFrame: up to approximately 40 months
measure: Duration of response （DoR）
timeFrame: up to approximately 40 months
measure: Adverse events (AEs)
timeFrame: up to approximately 40 months
Other outcomes:
Locations:
Study officials:
affiliation: Jiangsu HengRui Medicine Co., Ltd.
name: Jianjun Zou, MD, PhD
role: STUDY_DIRECTOR
affiliation: Jiaotong University,Shanghai chest Hospital
name: Shun Lu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: