Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).
NCT06663098 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142
Last updated 2025-03-13
Summary
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.
Conditions
- Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Interventions
- DRUG
-
1200 mg IV on day 1 of every 21 days, during induction phase and maintenance phase
- DRUG
-
AUC 4 or 5, depending on patient's characteristics, on day 1 every 21 days during induction phase
- DRUG
-
Etoposide
80 mg/sqm or 100 mg/sqm, depending on patient's characteristics, on days 1-2-3 of every 21 days
Sponsors & Collaborators
-
Roche Pharma AG
collaborator INDUSTRY -
Gruppo Oncologico Italiano di Ricerca Clinica
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-24
- Primary Completion
- 2028-08-30
- Completion
- 2029-06-01
Countries
- Italy
Study Locations
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