NCT07149363 · Alliance Foundation Trials, LLC.
Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
What this study is about
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
View original scientific description
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years.
- Body weight \>30 kg.
- Must have a life expectancy of at least 12 weeks.
- Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.
- Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.
- Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required.
- No prior systemic therapies, for small cell lung cancer.
- Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer.
- ECOG performance status 0-1.
Exclusion criteria
- Patients who are receiving any other investigational agents.
- Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.
- Prior treatment with durvalumab.
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Superficial bladder cancer without active disease after treatment.
- Low grade prostate cancer without indication for active treatment.
- Adequately treated carcinoma in situ without evidence of disease.
- Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.
- Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication.
- Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.
Where
- Chicago, Illinois
- Boston, Massachusetts
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations