Lung-MAP: Taselisib as Therapy in Treating Patients With Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches

Recurrent Squamous Cell Lung Carcinoma Clinical Trial

Official title: A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients With Stage IV Squamous Cell Lung Cancer (Lung-MAP Sub-Study)

Status Completed

Clinical Trial Summary

This phase II trial studies how well taselisib (GDC-0032) works in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for the phosphoinositide 3-kinase (PI3K) biomarker. PI3K can cause tumor cells to grow more quickly. Taselisib may decrease the activity of PI3K and may be able to shrink tumors.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Phase II Component: To evaluate if there is sufficient evidence to continue to the phase III component by evaluating the objective response rate (ORR) for PI3K Genentech (GNE)-positive patients registered to S1400B treated with GDC-0032. (Phase II)

II. Phase III Component: If the study meets the criteria specified in S1400, the study will be amended to include a follow-on randomized phase III trial.

SECONDARY OBJECTIVES:

I. To evaluate investigator-assessed progression free survival (IA-PFS) and overall survival (OS) in both the subset of patients defined to be PI3K GNE-positive and in the entire S1400B (PI3K Foundation Medicine [FMI] positive) study population treated with GDC-0032. (Phase II)

II. To evaluate ORR in the entire S1400B (PI3K FMI positive) study population treated with GDC-0032 to evaluate the duration of response (DoR) both in GNE positive and FMI positive. (Phase II)

III. To evaluate the DoR both in the entire S1400B PI3K FMI positive study population and in GNE positive patients treated with GDC-0032 who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. (Phase II)

IV. To evaluate the frequency and severity of toxicities associated with GDC-0032. (Phase II)

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To identify additional predictive tumor/blood biomarkers that may modify response or define resistance to the GDC-0032 beyond the chosen biomarker for biomarker-driven sub-studies.

II. To identify potential resistance biomarkers at disease progression.

III. To establish a tissue/ blood repository from patients with refractory squamous cell carcinoma (SCCA) of the lung.

OUTLINE: As of 12/18/2015, patients are assigned to Arm I.

ARM I: Patients receive taselisib orally (PO) daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel intravenously (IV) on day

1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon progression, patients may be eligible to re-register to Arm III.

Re-registration ARM III: Patients in Arm II eligible for re-registration receive taselisib orally (PO) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, all patients are followed up every 6 months for the first 2 years and then at the end of the year 3 from date of sub-study/re-registration. ;

Related Conditions & MeSH terms

• Carcinoma
• Lung Neoplasms
• Recurrent Squamous Cell Lung Carcinoma
• Stage IV Squamous Cell Lung Carcinoma

• NCT number: NCT02785913
• Study type: Interventional
• Source: Southwest Oncology Group
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Completion date: November 2019