Adjuvant chemotherapy plus durvalumab after complete resection of small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm, multicenter phase II study gives durvalumab with adjuvant chemotherapy to patients with completely resected pathologic T1–T2, N0–N1, M0 small cell lung cancer. Eligible patients must have had complete surgical resection with mediastinal lymph node dissection or systematic sampling within 78 days, be at least 18 years old, have ECOG 0–1, no prior systemic therapy, and meet basic weight and life-expectancy criteria. The trial's primary objective is to see if this combination improves 2-year disease-free survival using a predefined statistical design for alpha and power, while also monitoring safety. Treatment uses durvalumab (50 mg/mL) in combination with standard adjuvant chemotherapy per protocol and participants are followed for recurrence and adverse events.

Why it matters

Who can join: the full rules

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 it's running

• University of Illinois Chicago
  Chicago, Illinois, United States Recruiting
• Maine Medical Center
  Scarborough, Maine, United States Recruiting
• Massachusetts General Hospital (MGH)
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Washington University in St. Louis School of Medicine
  St Louis, Missouri, United States Recruiting
• University of Virginia Comprehensive Cancer Center
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Evanthia Galanis, MD — Alliance Foundation Trials, LLC.
• Study coordinator: Quality Management and Compliance
• Email: ClinicalTrials.Queries@alliancefoundationtrials.org
• Phone: 617-732-8727

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.