A Trial of SHR-1701 With or Without Famitinib in Patients With Advanced or Metastatic NSCLC

Phase 2

Withdrawn

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Drug: SHR-1701，Famitinib; Drug: SHR-1701

• Registration Number: NCT04699968
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without famitinib in patients with advanced or metastatic NSCLC

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Study Start: 2021-01-15
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. voluntarily participate in the study and sign the informed consent form;
2. 18 to 75 years old, both male and female;
3. histologically or cytologically confirmed stage IIIB-IV or recurrent NSCLC
4. one prior platinum-containing chemotherapy for advanced or metastatic disease;
5. measurable lesions by RECIST v1.1;
6. ECOG score: 0-1;
7. life expectancy ≥ 3 months;
8. adequate hematological, hepatic and renal function;
9. non-surgically sterile female subjects of childbearing age must have a negative serum HCG test.

Exclusion Criteria

1. histologically or cytologically confirmed mixed SCLC and NSCLC;
2. known sensitising EGFR mutation and/or ALK translocation in patients with non-squamous NSCLC;
3. tumor infiltration into the great vessels on imaging;
4. active CNS metastases;
5. malignancies other than NSCLC within 5 years;
6. anticancer therapy within 4 weeks before the start of trial treatment;
7. persisting toxicity related to prior therapy of Grade > 1;
8. treatment with systemic immunostimulatory agents within 4 weeks;
9. treatment with systemic immunosuppressive agents within 2 weeks;
10. autoimmune diseases;
11. interstitial lung disease or other lung diseases that is symptomatic or may interfere the management of suspected drug-related pulmonary toxicity;
12. clinically significant cardiovascular or cerebrovascular diseases;
13. inadequately controlled hypertension;
14. history of hemoptysis (≥ 2.5mL of bright red blood per episode) within 1 month;
15. venous or arterial thrombosis within 6 months;
16. evidence of bleeding diathesis or coagulopathy;
17. use of anticoagulants or thrombolytic agents that has not been stable;
18. active Tuberculosis infection;
19. significant acute or chronic infections within 1 month;
20. known history of testing positive test for HIV or known AIDS;
21. hepatitis B virus or hepatitis C virus infection;
22. allergic to any component of the treatment regimen;
23. other conditions that in the opinion of the investigator would make participation in this clinical trial inappropriate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR-1701，Famitinib	-
Treatment group B	SHR-1701	-

Primary Outcome Measures

Name	Time	Method
ORR	determined by RECIST v1.1, up to approximately 1 year	Objective Response Rate

Secondary Outcome Measures

Name	Time	Method
DCR	determined by RECIST v1.1, up to approximately 1 year	Disease Control Rate
DoR	determined by RECIST v1.1, up to approximately 1 year	Duration of Response
OS	up to approximately 1 year	Overall Survival
AEs+ SAEs	determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose	Adverse Events and Serious Adverse Events
PFS	determined by RECIST v1.1, up to approximately 1 year	Progression-Free-Survival