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Purpose

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

Condition

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.