A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer Who Progressed on Prior Immune Checkpoint Inhibitor Treatment and Platinum-Based Chemotherapy

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country1 target enrollmentJanuary 6, 2022

ConditionsAdvanced NSCLC

Interventionscamrelizumab + famitinib famitinib docetaxel

Drugscamrelizumab + famitinib famitinib docetaxel

Overview

Phase: Phase 3
Intervention: camrelizumab + famitinib
Conditions: Advanced NSCLC
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 1
Locations: 1
Primary Endpoint: OS
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate versus docetaxel as subsequent therapy in Advanced NSCLC.

Registry

clinicaltrials.gov

Start Date

January 6, 2022

End Date

May 11, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer.
•Failed previous platinum-based chemotherapy and anti-PD-(L)1 monoclonal antibody treatment.
•Have measurable disease based on RECIST v1.
•ECOG PS score: 0-
•Expected survival ≥ 3 months.
•Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and until 6 months after the last study dose.
•Subjects must participate voluntarily, sign the ICF, have good compliance, and cooperate with follow-up visits.

Exclusion Criteria

•Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
•Have known history of prior malignancy in the past 3 years.
•Have active pulmonary tuberculosis.
•Have clinical symptoms of the heart or heart diseases that are not well controlled.
•Have hypertension which cannot be well controlled by antihypertensives
•Urinalysis has indicated that the urine protein is ≥ ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is \> 1.0 g.
•Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
•Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤
•Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
•Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.