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

Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

This phase II study tests whether adding durvalumab immunotherapy to standard adjuvant chemotherapy helps adults with completely resected early-stage small cell lung cancer stay cancer-free longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Alliance Foundation Trials, LLC. (Academic / other)
• Drugs / interventions: durvalumab, radiation, chemotherapy, immunotherapy
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT07149363 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with completely resected pathologic T1–T2, N0–N1, M0 SCLC who had mediastinal lymph node sampling or dissection within 78 days of surgery, have ECOG 0–1, no prior systemic therapy, weigh >30 kg, and have at least a 12-week life expectancy.

Not a fit: Patients with more advanced disease (N2 or metastatic), prior systemic therapy for SCLC, poor performance status (ECOG ≥2), or contraindications to immunotherapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce recurrence and lengthen disease-free survival after surgery for early-stage SCLC.

How similar studies have performed: Checkpoint inhibitors like durvalumab and atezolizumab have improved outcomes when added to chemotherapy in extensive-stage SCLC, but adjuvant use after complete resection in early-stage SCLC is largely untested.

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.

Where this trial is running

Charlottesville, Virginia

• 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

Conditions Small Cell Lung Cancer