Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

Purpose

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

Condition

  • Small Cell Lung Cancer (SCLC)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Durvalumab and one of the two chemotherapy combinations: cisplatin or carboplatin, and etoposide 		65 participants will be enrolled.
  • Drug: 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).
    Other names:
    • Imfinzi®
    • MEDI4736

Recruiting Locations

University of Virginia Comprehensive Cancer Center
Charlottesville 4752031, Virginia 6254928 22908

More Details

Status
Recruiting
Sponsor
Alliance Foundation Trials, LLC.

Study Contact

Quality Management and Compliance
617-732-8727
ClinicalTrials.Queries@alliancefoundationtrials.org

Detailed Description

This is a phase II open-label, single-arm, multi-center study to evaluate the efficacy and safety of adjuvant immunotherapy with chemotherapy for completely resected pathologic T1-T2, N0-N1, M0 small cell lung cancer (SCLC). The statistical design includes a predefined range of alpha and power to detect an improvement in 2-year disease free survival (DFS).