Adjuvant Chemotherapy and Immunotherapy for Small Cell Lung Cancer

This study is testing a combination of chemotherapy and immunotherapy (Durvalumab) after surgery for small cell lung cancer (SCLC). You might be able to join if you are at least 18 years old, have a life expectancy of at least 12 weeks, and have had your SCLC completely removed by surgery. The researchers want to see if this treatment can help people stay disease-free for at least two years after treatment. The current recruitment status for this study is unclear.

Study design
This is a Phase II, open-label, single-arm study, meaning all participants will receive the same treatment and both you and your doctors will know what treatment you are getting. It plans to enroll 65 participants.
What's involved
Participants will receive Durvalumab along with cisplatin or carboplatin, and etoposide every three weeks for a total of 12 weeks (4 cycles).
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long participants remain disease-free for at least two years after treatment.

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NCT07149363

Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Alliance Foundation Trials, LLC.
~65 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Durvalumab 50 MG/ML

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease free survival (DFS)
Measured over 2 years
Small Cell Lung Cancer (SCLC)
3 sites across 3 states
Illinois1
Massachusetts1
Virginia1
  • Chi-Fu Jeffrey Yang, MD · STUDY_CHAIR · Massachusetts General Hospital
  • Jacob Sands, MD · STUDY_CHAIR · Dana-Farber Cancer Institute
  • Evanthia Galanis, MD · PRINCIPAL_INVESTIGATOR · Alliance Foundation Trials, LLC.

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Eligibility criteria

Inclusion

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

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.
  • Disease free survival (DFS)2 years

    To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved disease free survival (DFS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. DFS is measured in months from the time of surgery.