Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

NCT07149363 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AFT-61
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS)

  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.

  2 years

Secondary Outcomes (3)

• Overall survival (OS)

  3 years

• Safety of the regimen

  1 year

• Safety of the regimen

  5 years

Study Arms (1)

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

EXPERIMENTAL

65 participants will be enrolled.

Drug: Durvalumab 50 MG/ML

Interventions

Durvalumab 50 MG/ML DRUG

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).

Also known as: Imfinzi®, MEDI4736

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: collaborator
• Alliance Foundation Trials, LLC.: lead

Study Sites (1)

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chi-Fu Jeffrey Yang, MD

  Massachusetts General Hospital

  STUDY CHAIR

• Jacob Sands, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

• Evanthia Galanis, MD

  Alliance Foundation Trials, LLC.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quality Management and Compliance

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 2, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)