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
Overview
- Phase
- Phase 2
- Intervention
- SHR-1210
- Conditions
- NSCLC Stage IV
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
- Status
- Terminated
- Last Updated
- 10 months ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
SHR-1210 +apatinib
subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day
Intervention: SHR-1210
SHR-1210 +apatinib
subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day
Intervention: Apatinib
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
Intervention: Pemetrexed
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
Intervention: Carboplatin
Outcomes
Primary Outcomes
Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
Time Frame: up to approximately 40 months
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.
Secondary Outcomes
- Objective Response Rate (ORR)(up to approximately 40 months)
- 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)
- disease control rate (DCR)(up to approximately 40 months)
- Duration of response （DoR）(up to approximately 40 months)
- Adverse events (AEs)(up to approximately 40 months)