A Study of Sequential Therapy of Camrelizumab Combined With Chemotherapy（Irinotecan Plus Platinum）and With Apatinib in Participants With Untreated Advanced Small Cell Lung Cancer（SCLC）

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04453930
Phase
PHASE2
Status
Unknown

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab，an engineered anti-PD-1 antibody — 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 1-4/5/6) and maintenance phase (Cycle onward).
  • Platinum — DRUG
    Carboplatin： 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 1-4/5/6). Cisplatin： Cisplatin intravenous infusion was administered at a dose of 30 milligrams per square meter (mg/m\^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6).
  • Irinotecan — DRUG
    Irinotecan intravenous infusion was administered at a dose of 65 milligrams per square meter (mg/m\^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6).
  • Apatinib — DRUG
    Apatinib was administered at a dose of 250 mg during the maintenance phase.

Study Details

This single arm, open label, single center, prospective study was designed to evaluate the safety and efficacy of Sequential Therapy of Camrelizumab (humanized monoclonal antibody against Programmed death 1 \[PD-1\] ) in combination with Chemotherapy（Irinotecan plus Platinum）and with Apatinib (selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor \[TKI\]) in chemotherapy-naive participants with SCLC. Participants will receive Camrelizumab + Irinotecan + Platinum on 21-day cycles for 4-6 cycles in the induction phase followed by maintenance with Camrelizumab + 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
Jun 8, 2020
Status verified
Jun 2020
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023

Study Design

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

Arms

  • Experimental: Camrelizumab+Irinotecan+Platinum→Camrelizumab+apatinib
    Participants received intravenous infusions of Camrelizumab 200 mg in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) or Cisplatin 30 milligrams per square meter (mg/m\^2) followed by Irinotecan 65 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4/5/6). On Days 8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6), Cisplatin 30 mg/m\^2 and Irinotecan 65 mg/m\^2 was administered. Thereafter, participants received maintenance (Cycle onward) Camrelizumab 200 mg on Day 1 of every 21-day cycle with Apatinib 250mg until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

Primary Outcome Measure

Progression-free Survival (PFS) as assessed by RECIST 1.1 [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years. ]

Central Contacts

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