NCT04267913

Testing of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel to the Usual Standard of Care for Advanced Squamous Cell Lung Cancer (A Lung-MAP Treatment Trial)

A Randomized Phase II Study of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel Versus Standard of Care in Patients With Previously - Treated NFE2L2 or KEAP1-Positive Stage IV or Recurrent Squamous Cell Lung Cancer (ECOG-ACRIN LUNG-MAP Sub-Study)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II LUNG-MAP treatment trial studies how well sapanisertib and docetaxel work for the treatment for squamous cell lung cancer that is stage IV or has come back (recurrent). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sapanisertib and docetaxel may work better in treating patients with squamous cell lung cancer compared to standard chemotherapy.

Detailed description

PRIMARY OBJECTIVE: I. To compare the investigator-assessed progression-free survival (IA-PFS) between patients with NFE2L2 or KEAP1-positive stage IV or recurrent squamous cell lung cancer (SQCLC) randomized to TAK228 (MLN0128, sapanisertib) + docetaxel versus standard of care therapy. SECONDARY OBJECTIVES: I. To compare overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the treatment arms. II. To compare overall survival (OS) between the treatment arms. III. To evaluate duration of response (DOR) among responders within each treatment arm. IV. To evaluate and compare the frequency and severity of toxicities associated within each treatment arm. V. To evaluate outcomes of IA-PFS, OS, and response in the subsets of patients eligible based on the presence of NFE2L2 versus KEAP1 alterations. TRANSLATIONAL MEDICINE OBJECTIVES: I. To collect, process, and bank cell-free deoxyribonucleic acid (DNA) (cfDNA) at baseline, cycle 2 day 1, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA). II. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC). OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive docetaxel intravenously (IV) and dexamethasone IV over 30 minutes on days 1 and 8 and sapanisertib orally (PO) once daily (QD) on days 2-4, 9-11, and 16-18. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. If docetaxel is discontinued, patients receive sapanisertib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive standard of care treatment comprising either docetaxel IV and dexamethasone IV over 30 minutes on day 1 or docetaxel IV, dexamethasone IV over 30 minutes, and ramucirumab IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years and then at 3 years.

Conditions

• Lung Squamous Cell Carcinoma
• Recurrent Lung Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given IV
DRUG	Docetaxel	Given IV
BIOLOGICAL	Ramucirumab	Given IV
DRUG	Sapanisertib	Given PO

Timeline

• Start date: 2020-09-05
• Primary completion: 2025-10-31
• Completion: 2026-10-31
• First posted: 2020-02-13
• Last updated: 2020-11-20

Regulatory

• FDA-regulated drug study