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

Chemotherapy Effect Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03777124
• Other study ID #: SHR-1210-II-214
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2019
• Est. completion date: April 2022

Study information

• Verified date: December 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Jianjun Zou, MD, PhD
• Phone: 021-60453139
• Email: zoujianjun[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: April 2022
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Chemotherapy Effect
• KRAS Gene Mutation
• NSCLC Stage IV
• PD-1 Antibody

Intervention

Drug:
• SHR-1210
Subjects receive SHR-1210 intravenous every 2 weeks
• Apatinib
Subjects receive Apatinib orally every day
• Pemetrexed
Subjects receive Pemetrexed intravenous every 3 weeks
• Carboplatin
subjects receive carboplatin intravenous every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.	Shanghai Chest Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1	Time Frame: Baseline until PD or death, whichever occurs first	up to approximately 40 months
Secondary	Duration of Overall Survival (OS)	Baseline until death from any cause	up to approximately 40 months
Secondary	Objective Response Rate (ORR)	The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1.	up to approximately 40 months
Secondary	disease control rate (DCR)	The proportion of patients who have achieved complete response, partial response and Stable disease assessed by investigators according to Recist v 1.1.	up to approximately 40 months
Secondary	Duration of response (DoR)	Duration of response (DoR)	up to approximately 40 months
Secondary	Adverse events (AEs)	All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0	up to approximately 40 months