Actively Recruiting
A Simulated RCT Study on the Efficacy of Atezolizumab Combined with Chemotherapy Versus Placebo Combined with Chemotherapy in Small Cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2025-01-17
1430
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of atezolizumab combined with chemotherapy compared to placebo combined with chemotherapy in treating small cell lung cancer. This multicenter phase III randomized controlled trial focuses on patients with extensive-stage small cell lung cancer (ES-SCLC), aiming to improve outcomes with this combination treatment. Participants receive either atezolizumab together with carboplatin and etoposide or chemotherapy alone with carboplatin and etoposide. Atezolizumab is given as a 1200 mg intravenous infusion every 21 days, while chemotherapy drugs are administered intravenously in the same 21-day cycle. The study design includes separate groups to compare these treatment approaches. During the study, participants undergo regular assessments including imaging scans and laboratory tests to monitor disease progression and treatment response. Researchers measure progression-free survival over 12 months as the main outcome, along with response rates and duration of response. Safety and side effects are closely tracked throughout the trial, which is sponsored by Shanghai Pulmonary Hospital and involves multiple centers.
CONDITIONS
Brief 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
- No prior treatment for extensive-stage small cell lung cancer
- History of treated asymptomatic CNS metastases allowed under specific conditions
- Measurable disease as per RECIST v1.1
- Adequate hematologic and organ function based on specified laboratory results
- Willingness to submit a pre-treatment tumor tissue sample
- For women of childbearing potential: agreement to use effective contraception or abstain from heterosexual intercourse during and for 90 days after treatment
You will not qualify if you...
- Active or untreated CNS metastases
- Untreated or unstable spinal cord compression
- Leptomeningeal disease
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Uncontrolled or symptomatic hypercalcemia
- Other malignancies within 5 years except certain low-risk cancers
- Pregnant, lactating, or intending pregnancy during the study
- Severe allergic reactions to antibodies or components of atezolizumab
- History of autoimmune diseases with some exceptions
- History of pneumonitis or active pneumonitis on screening
- Positive test for HIV or active hepatitis B or C infection
- Active tuberculosis or severe infections at enrollment
- Significant cardiovascular disease or recent major surgery
- Prior allogeneic bone marrow or solid organ transplant
- Any condition that contraindicates investigational drug use or affects study results
- Previous anti-cancer therapy for extensive-stage small cell lung cancer
- Recent participation in other therapeutic clinical trials
- Recent live attenuated vaccine administration or anticipated need during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants are observed without receiving study interventions as this is an observational study.
Periodic visits over 12 months
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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