Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

Alliance Foundation Trials

Status and phase

Not yet enrolling

Phase 2

Conditions

Small Cell Lung Cancer (SCLC)

Treatments

Drug: Durvalumab 50 MG/ML

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07149363

AFT-61

Details and patient eligibility

About

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

Full 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).

Enrollment

65 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.