NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer

NCT07149363

RecruitingPhase 2

Sponsor: Alliance Foundation Trials, LLC.

Conditions: Small Cell Lung Cancer (SCLC)

Interventions: Durvalumab 50 MG/ML

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (3)
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Charlottesville, Virginia, United States