Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).

Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
Study ID
NCT06663098
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    1200 mg IV on day 1 of every 21 days, during induction phase and maintenance phase
  • Carboplatin — DRUG
    AUC 4 or 5, depending on patient's characteristics, on day 1 every 21 days during induction phase
  • Etoposide — DRUG
    80 mg/sqm or 100 mg/sqm, depending on patient's characteristics, on days 1-2-3 of every 21 days

Study Details

The goal of this clinical trial is to learn if a combination of atezolizumab and standard chemotherapy works to treat sensitive Extensive-stage Small Cell Lung Cancer, progressing after first-line of treatment. The main questions it aims to answer are: * Does combination of atezolizumab and standard chemotherapy increase overall survival? * What medical problems do participants have when taking combination of atezolizumab and standard chemotherapy? Participants will: * take atezolizumab and standard chemotherapy every 3 weeks for 4 cycles and than atezolizumab every 3 weeks up to 18 cycles. * visit the clinic once every 3 weeks for checkups and tests * perform Radiological assessments after 6 weeks and then every 12 weeks to determine response to treatment.

Key Dates

Start date
Jan 24, 2025
Status verified
Mar 2025
Primary completion
Aug 30, 2028
Completion
Jun 1, 2029

Study Design

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

Arms

  • Experimental: Arm 1
    re-challenge chemotherapy plus atezolizumab 1200 mg flat dosing

Primary Outcome Measure

overall survival [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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