Chemotherapy Effect, KRAS Gene Mutation, NSCLC Stage IV, PD-1 Antibody
Conditions
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
Interventions
DRUGSHR-1210
Subjects receive SHR-1210 intravenous every 2 weeks
DRUGApatinib
Subjects receive Apatinib orally every day
DRUGPemetrexed
Subjects receive Pemetrexed intravenous every 3 weeks
DRUGCarboplatin
subjects receive carboplatin intravenous every 3 weeks
Sponsors
Shanghai Chest Hospital
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1 | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Overall Survival (OS) | up to approximately 40 months | Baseline until death from any cause |
| Objective Response Rate (ORR) | up to approximately 40 months | The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1. |
| Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 | up to approximately 40 months | Time Frame: Baseline until PD or death, whichever occurs first |
| Duration of response （DoR） | up to approximately 40 months | Duration of response （DoR） |
| Adverse events (AEs) | up to approximately 40 months | All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0 |
| disease control rate (DCR) | up to approximately 40 months | The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1. |
Countries
China
Outcome results
None listed