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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: SHR-1701，Famitinib; Drug: SHR-1701

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei Shi, M.D; Phone Number: +86 021-61053363; Email: shiwei@hrglobe.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: SHR-1701，Famitinib; SHR -1701, Intravenous ；Famitinib, oral
Experimental: Treatment group B	Drug: SHR-1701; SHR -1701, Intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	determined by RECIST v1.1, up to approximately 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-Free-Survival	determined by RECIST v1.1, up to approximately 1 year
DCR	Disease Control Rate	determined by RECIST v1.1, up to approximately 1 year
DoR	Duration of Response	determined by RECIST v1.1, up to approximately 1 year
OS	Overall Survival	up to approximately 1 year
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2021
• Primary Completion (Estimated): November 15, 2021
• Study Completion (Estimated): November 15, 2021

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SHR-1701-Ⅱ-206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No