OncRef

Clinical Trial: NCT02503722

Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-06-11

Study Overview

Brief Summary

This phase I trial studies the side effects and best dose of sapanisertib when given together with osimertinib in treating patients with stage IV EGFR mutation positive non-small cell lung cancer that has progressed after treatment with an EGFR tyrosine kinase inhibitor. Sapanisertib and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Official Title

A Phase 1 Trial of MLN0128 (TAK-228) in Combination With Osimertinib (AZD9291) in Advanced EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC) After Progression on a Previous EGFR Tyrosine Kinase Inhibitor

Conditions

Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage III Lung Non-Small Cell Cancer AJCC v7, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage IV Lung Non-Small Cell Cancer AJCC v7

Intervention / Treatment

  • Other: Laboratory Biomarker Analysis
  • Drug: Osimertinib
  • Other: Pharmacological Study
  • Drug: Sapanisertib

Other Study ID Numbers

  • NCI-2015-01139
  • NCI-2015-01139
  • PJC-020
  • 9910/PJC-020
  • 9910
  • 9910
  • UM1CA186644
  • UM1CA186689

Start Date (Actual)

2017-03-23

Primary Completion Date (Estimated)

2027-02-28

Study Completion Date (Estimated)

2027-02-28

Enrollment (Estimated)

36

Study Type

Interventional

Phase

Phase 1