NCT01737502

Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer

A Phase I-II Trial of Combined PKCι and mTOR Inhibition for Patients With Advanced or Recurrent Lung Cancer (NSCLC and SCLC) Without Standard Treatment Options

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of auranofin when given together with sirolimus and to see how well it works in treating patients with lung cancer that has spread or other places in the body and cannot be cured or controlled by treatment or has come back after a period of time during which the cancer could not be detected. Auranofin and sirolimus may stop or slow the growth of lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose of auranofin plus sirolimus after at least one line of platinum based chemotherapy for lung cancer (squamous, ras-mutated adenocarcinoma, or small cell lung cancer) patients with no acceptable standard treatment options. (Phase I) II. To assess the progression-free survival at four months of patients treated with auranofin after at least one line of platinum based chemotherapy for lung cancer (squamous, ras-mutated adenocarcinoma, or small cell lung cancer) patients with no acceptable standard treatment options. (Phase II) SECONDARY OBJECTIVES: I. To assess the overall survival in this population in comparison to recent historical controls. II. To determine the adverse events (AE) profile and safety of the regimen. III. To determine the overall response rate, per Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and duration of tumor response in those patients with measurable disease. TERTIARY OBJECTIVES: I. To assess the relationship between molecular correlates and progression-free survival (PFS), overall survival (OS), response and adverse events. OUTLINE: This is a phase I, dose-escalation study of auranofin followed by a phase II study. Patients receive auranofin orally (PO) on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3-6 months for 5 years.

Conditions

• Extensive Stage Small Cell Lung Carcinoma
• Lung Adenocarcinoma
• Recurrent Non-Small Cell Lung Carcinoma
• Recurrent Small Cell Lung Carcinoma
• Squamous Cell Lung Carcinoma
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Auranofin	Given PO
DRUG	Sirolimus	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2014-05-14
• Primary completion: 2023-04-24
• Completion: 2023-04-24
• First posted: 2012-11-29
• Last updated: 2025-09-05
• Results posted: 2025-08-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study