Camrelizumab Combined With Apatinib ,Carboplatin and Etoposide in Participants With ES-SCLC

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT04683198
Phase
PHASE2
Status
Unknown

Conditions

  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • camrelizumab — DRUG
    Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6) and maintenance phase ,until PD.
  • Apatinib Mesylate — DRUG
    Apatinib capsules 250 mg given orally , once daily in 21-day cycle and maintenance phase,until PD.
  • Carboplatin — DRUG
    Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6).
  • Etoposide — DRUG
    Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6).

Study Details

This single-arm, Phase II, multicenter study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 \[PD-1\] antibody) in combination with Apatinib+carboplatin plus (+) etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be receive camrelizumab +apatinib+ carboplatin + etoposide on 21-day cycles for four -six cycles in the induction phase followed by maintenance with camrelizuab +apatinib until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

Key Dates

Start date
Apr 1, 2021
Status verified
Oct 2020
Primary completion
Oct 30, 2023
Completion
Jun 30, 2024

Study Design

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

Arms

  • Experimental: Experimental: camrelizumab +apatinib+ Carboplatin + Etoposide
    Induced stage：camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally +Etoposide (100mg/m2 IV continuously on Day 1, 2 and 3）+Carboplatin（AUC 5 mg/mL/min IV on Day 1 ; maintenance stage：Camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally, once daily in 21-day cycle .

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 [ Time Frame: Baseline until PD or death, whichever occurs first (up to approximately 13 months) ]

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