Actively Recruiting
Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
Led by Alliance Foundation Trials, LLC. · Updated on 2026-02-17
65
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
Alliance Foundation Trials, LLC.
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of chemotherapy and immunotherapy as additional treatment for patients with small cell lung cancer (SCLC) that has been completely removed by surgery. This phase II, open-label study focuses on patients with early-stage SCLC (pathologic T1-T2, N0-N1, M0) to assess the safety and effectiveness of this combined treatment approach in improving disease-free survival over two years. Participants will receive a treatment regimen starting with 12 weeks of chemotherapy combined with immunotherapy. The chemotherapy includes either cisplatin or carboplatin plus etoposide, given every three weeks for four cycles, alongside durvalumab immunotherapy. After this initial phase, participants will continue with durvalumab alone every four weeks for nine cycles, totaling 36 weeks. The study is designed as a single-arm trial involving 65 participants. During the trial, participants will undergo regular monitoring to assess disease status and treatment safety. Researchers will measure disease-free survival at two years as the primary outcome, along with overall survival over three years and safety evaluations at one and five years. Participants will be followed closely throughout treatment and afterward to monitor their health and response to the therapy over time.
CONDITIONS
Brief Title
Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Body weight greater than 30 kg
- Life expectancy of at least 12 weeks
- Histologically or cytologically confirmed pathologic T1-T2 N0-1 M0 small-cell lung cancer
- Completely resected small-cell lung cancer within 78 days prior to enrollment
- Complete mediastinal lymph node dissection or systematic mediastinal lymph node sampling
- No prior systemic therapies for small cell lung cancer
- Post-operative radiation allowed for N1 disease only
- ECOG performance status of 0 or 1
You will not qualify if you...
- Receiving any other investigational agents
- Enrolled in another clinical study involving investigational treatment for small cell lung cancer
- Prior treatment with durvalumab
- History of another primary malignancy except specified low-risk cases
- History of cerebrovascular accident, pulmonary embolism, or untreated deep venous thrombosis within past 3 months
- Hemoptysis exceeding 2.5 mL within 2 weeks before study medication
- Need for concomitant therapy with phenytoin, phenobarbital, or carbamazepine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 78 days prior to enrollment
Participants are screened for eligibility to participate in the trial.
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Duration - Approximately 48 weeks total
Participants receive a combination of chemotherapy and immunotherapy. This includes 4 cycles of chemotherapy plus durvalumab every 3 weeks (total 12 weeks), followed by durvalumab every 4 weeks for 9 cycles (total 36 weeks).
Regular visits every 3 weeks during chemotherapy cycles, then every 4 weeks during durvalumab treatment
Trial Site Locations
Total: 1 location
1
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
Q
Quality Management and Compliance
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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