Camrelizumab Combined With Apatinib Mesylate and Standard Chemotherapy (Pemetrixed + Carboplatin) in Patients With Tyrosine Kinase Inhibitor Failure in ALK-positive Advanced NSCLC

Sponsor
The First Affiliated Hospital of Xiamen University
Study ID
NCT04425135
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200mg,D1,ivgtt, Q3w.
  • Apatinib — DRUG
    250mg,Qd,Q3W.
  • Pemetrixed — DRUG
    500 mg/m2,D1,ivgtt, Q3w.
  • Carboplatin — DRUG
    AUC=5\~6,D1,ivgtt, Q3w.

Study Details

This study is a phase II single-arm clinical study.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with apatinib mesylate and standard chemotherapy (pemetrexed plus carboplatin) in patients with advanced non-squamous and non-small cell lung cancer who have failed tyrosine kinase inhibitor therapy and are ALK-positive.

Key Dates

Start date
Jul 31, 2020
Status verified
Jun 2020
Primary completion
Jan 31, 2023
Completion
Jan 31, 2025

Study Design

Enrollment
59 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab +apatinib mesylate+Pemetrixed + Carboplatin
    Camrelizumab combined with apatinib mesylate,Pemetrixed and Carboplatin in the treatment（4-6 cycle）of effective (CR, PR, SD) patients continued to be treated with Camrelizumab combined with apadine mesylate until PD, toxicity intolerance, and other reasons that the researcher thinks need to stop the research treatment.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: up to approximately 1 year ]

Central Contacts

Related Studies