Recruiting
Phase 2

Chemotherapy & Immunotherapy

Sponsor:

Alliance Foundation Trials, LLC.

Code:

NCT07149363

Conditions

Small Cell Lung Cancer (SCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Durvalumab 50 MG/ML

Study Details

Brief summary:

This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).

Conditions

Small Cell Lung Cancer (SCLC)

Study ID

NCT07149363

Start date

Feb 12, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Durvalumab and one of the two chemotherapy combinations: cisplatin or carboplatin, and etoposide

65 participants will be enrolled.

Interventions

Durvalumab 50 MG/ML

Following surgical removal of their small-cell lung cancer, participants will receive a combination of 1500 mg durvalumab and cisplatin 75 mg/m2 or carboplatin AUC 5 on day 1, and etoposide 100 mg/m2 on days 1, 2, and 3, every 3 weeks for 4 cycles (a total of 12 weeks). Following the combination of chemotherapy and immunotherapy, participants will then receive 1500 mg durvalumab every 4 weeks for 9 cycles (a total of 36 weeks).

Primary outcome measure

  • Disease free survival (DFS) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Quality Management and Compliance

617-732-8727ClinicalTrials.Queries@alliancefoundationtrials.org

Locations

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Virginia Comprehensive Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

More Information

Sponsor

Alliance Foundation Trials, LLC.

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alliance Foundation Trials, LLC. on 2026-06-26.