NCT07149363 Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
| NCT ID | NCT07149363 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alliance Foundation Trials, LLC. |
| Condition | Small Cell Lung Cancer (SCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2026-02-12 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 65 participants in total. It began in 2026-02-12 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
Eligibility Criteria
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.
Contact & Investigator
Quality Management and Compliance
✉ ClinicalTrials.Queries@alliancefoundationtrials.org📞 617-732-8727
Chi-Fu Jeffrey Yang, MD
STUDY CHAIR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07149363 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer (SCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07149363 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07149363 currently recruiting?
Yes, NCT07149363 is actively recruiting participants. Contact the research team at ClinicalTrials.Queries@alliancefoundationtrials.org for enrollment information.
Where is the NCT07149363 trial being conducted?
This trial is being conducted at Chicago, United States, Boston, United States, Charlottesville, United States.
Who is sponsoring the NCT07149363 clinical trial?
NCT07149363 is sponsored by Alliance Foundation Trials, LLC.. The principal investigator is Chi-Fu Jeffrey Yang, MD at Massachusetts General Hospital. The trial plans to enroll 65 participants.
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