Spots Global Cancer Trial Database for Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer

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Trial Identification

Brief Title: Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer

Official Title: A Phase 2 Study of MLN0128 (TAK-228) in Patients With Advanced Non-Small Cell Lung Cancers Harboring NFE2L2 and KEAP1 Mutations

Study ID: NCT02417701

Conditions

Recurrent Lung Squamous Cell Carcinoma

Stage IV Lung Squamous Cell Carcinoma AJCC v7

Interventions

Laboratory Biomarker Analysis

Pharmacological Study

Sapanisertib

Study Description

Brief Summary: This phase II trial studies how well sapanisertib works in treating patients with lung cancer that is stage IV or has come back (recurrent) and has a mutation in the NFE2L2, KEAP-1, or KRAS gene. Damage to these genes may cause the cancer to grow. Sapanisertib may stop this from happening by blocking enzymes.

Detailed Description: PRIMARY OBJECTIVE: I. Evaluate the overall response rate of the TORC1/TORC2 inhibitor sapanisertib (MLN0128 \[TAK-228\]) in stage IV squamous cell lung cancers or KRAS mutant lung cancers harboring NFE2L2 or KEAP1 mutations. SECONDARY OBJECTIVES: I. To evaluate the median progression free survival of patients in each cohort. II. To explore the feasibility of performing reverse phase protein array analysis (RPPA) in paired snap-frozen core biopsies from patients in this study prior to MLN0128 (TAK-228) dosing and during week 2 of treatment. III. To describe the effectiveness of MLN0128 (TAK-228) in suppressing activation of mTOR and PI3K signaling through the exploratory RPPA analysis. OUTLINE: Patients receive sapanisertib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.