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

Non-Small-Cell Lung Cancer Clinical Trial

Official title:

Phase II Clinical Trial of SHR-1701 With or Without Famitinib in the Treatment of Advanced or Metastatic NSCLC

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04699968
• Other study ID #: SHR-1701-?-206
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 15, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: June 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• SHR-1701,Famitinib
SHR -1701, Intravenous ;Famitinib, oral
• SHR-1701
SHR -1701, Intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

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