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

NCT04699968 | Withdrawn Phase 2

• 1 other identifier: SHR-1701-Ⅱ-206
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  determined by RECIST v1.1, up to approximately 1 year

Secondary Outcomes (5)

• PFS

  determined by RECIST v1.1, up to approximately 1 year

• DCR

  determined by RECIST v1.1, up to approximately 1 year

• DoR

  determined by RECIST v1.1, up to approximately 1 year

• OS

  up to approximately 1 year

• AEs+ SAEs

  determined by NCI-CTCAE V5.0, from the first drug administration to within 90 days for the last SHR-1701 dose

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR-1701，Famitinib

Treatment group B

EXPERIMENTAL

Drug: SHR-1701

Interventions

SHR-1701，Famitinib DRUG

SHR -1701, Intravenous ；Famitinib, oral

Treatment group A

SHR-1701 DRUG

SHR -1701, Intravenous

Treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• histologically or cytologically confirmed mixed SCLC and NSCLC;
• known sensitising EGFR mutation and/or ALK translocation in patients with non-squamous NSCLC;
• tumor infiltration into the great vessels on imaging;
• active CNS metastases;
• malignancies other than NSCLC within 5 years;
• anticancer therapy within 4 weeks before the start of trial treatment;
• persisting toxicity related to prior therapy of Grade \> 1;
• treatment with systemic immunostimulatory agents within 4 weeks;
• treatment with systemic immunosuppressive agents within 2 weeks;
• autoimmune diseases;
• interstitial lung disease or other lung diseases that is symptomatic or may interfere the management of suspected drug-related pulmonary toxicity;
• clinically significant cardiovascular or cerebrovascular diseases;
• inadequately controlled hypertension;
• history of hemoptysis (≥ 2.5mL of bright red blood per episode) within 1 month;
• venous or arterial thrombosis within 6 months;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

SHR-1701

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-1701 with or without Famitinib

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: January 15, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: June 7, 2023

Record last verified: 2023-06