Actively Recruiting
A Study Comparing Atezolizumab Plus Chemotherapy With Chemotherapy Alone in Small Cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2025-01-17
1430
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness and safety of combining atezolizumab with chemotherapy compared to placebo with chemotherapy in treating small cell lung cancer. This is a multicenter phase III randomized controlled trial focusing on patients with extensive-stage small cell lung cancer (ES-SCLC) who have not received prior treatment. The study aims to assess progression-free survival over 12 months. Participants receive treatments in cycles every 21 days. One group is given atezolizumab at 1200 mg by intravenous infusion alongside chemotherapy drugs etoposide and carboplatin, while the other group receives placebo with the same chemotherapy regimen. The chemotherapy includes etoposide at 100 mg/m and carboplatin dosed by area under the curve (AUC) of 5, both administered intravenously every 21 days. During the study, participants undergo regular assessments including tumor measurements defined by RECIST v1.1, laboratory tests to monitor blood counts and organ function, and imaging to evaluate disease status. Patients must provide tumor tissue samples before or shortly after enrollment. Safety and treatment effects are closely monitored throughout the treatment period and follow-up to evaluate progression-free survival and adverse events.
CONDITIONS
Official Title
A Study on the Efficacy of Atezolizumab Combined with Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed Informed Consent Form
- Male or female, 18 years of age or older
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed extensive-stage small cell lung cancer per VALG staging system
- No prior treatment for extensive-stage small cell lung cancer
- History of treated asymptomatic CNS metastases allowed if stable and meeting specific criteria
- Measurable disease by RECIST v1.1 criteria
- Adequate blood counts and organ function within 14 days prior to randomization
- Submission of pre-treatment tumor tissue sample during the study
- For women of childbearing potential, agreement to use contraception or abstain from heterosexual intercourse during treatment and for 90 days after last dose
You will not qualify if you...
- Active or untreated CNS metastases
- Spinal cord compression not definitively treated or unstable
- Leptomeningeal disease
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Uncontrolled or symptomatic hypercalcemia
- Other malignancies within 5 years except low risk treated cancers
- Pregnancy, lactation, or intention to become pregnant during study
- History of severe allergic reactions to chimeric or humanized antibodies
- Known allergy to atezolizumab components
- History of autoimmune diseases with exceptions for stable hypothyroidism, controlled Type I diabetes, and certain dermatologic conditions
- History of certain lung diseases or active pneumonitis
- Positive HIV test
- Active hepatitis B or C infections
- Active tuberculosis
- Severe infections at enrollment
- Significant cardiovascular disease or recent myocardial infarction
- Major surgery within 28 days prior to randomization
- Prior allogeneic bone marrow or solid organ transplant
- Other conditions that contraindicate investigational drug use or affect study results
- Previous anti-cancer therapy for extensive-stage small cell lung cancer
- Use of other investigational agents or clinical study participation within 28 days
- Live attenuated vaccine within 4 weeks before randomization or planned during study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
C
Chunxia Su, doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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