Combined Atezolizumab and Chemotherapy (Carboplatin Plus Etoposide) in Neoadjuvant Treating Limited-Stage Small Cell Lung Cancer Patients

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Study ID
NCT04696939
Phase
PHASE2
Status
Unknown

Conditions

  • Neoadjuvant Therapy
  • Small-cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.
  • Carboplatin — DRUG
    Carboplatin intravenous infusion was administered at a dose of 75mg/m\^2 on Day 1 of each 21-day cycle.
  • Etoposide — DRUG
    Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Day 1 of every 3-day cycle.

Study Details

This Phase II study was designed to evaluate the safety and efficacy of Atezolizumab in combination with Chemotherapy compared with treatment with Chemotherapy alone in previously untreated Limited-Stage Small Cell Lung Cancer patients.

Key Dates

Start date
Jan 31, 2021
Status verified
Jan 2021
Primary completion
Aug 31, 2022
Completion
Oct 31, 2023

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Carboplatin +Etoposide +surgery
    Neoadjuvant therapy: Atezolizumab, 1200 milligrams(mg) on Day 1 of every 21-day cycle, 2 cycles; Carboplatin, 75 mg per square meter(mg/m\^2) on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m\^2 on Day 1 of every 3-day cycle, 2 cycles. Surgery: patients will receive surgery.
  • Active Comparator: Carboplatin +Etoposide +surgery
    Neoadjuvant therapy: Carboplatin, 75 mg/m\^2 on Day 1 of every 21-day cycle, 2 cycles; Etoposide, 100 mg/m\^2 on Day 1 of every 3-day cycle, 2 cycles. Surgery: patients will receive surgery.

Primary Outcome Measure

Disease free survival（DFS） [ Time Frame: 12 months ]

Central Contacts

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