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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02503722
Phase
PHASE1
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Osimertinib — DRUG
    Given PO
  • Pharmacological Study — OTHER
    Correlative studies
  • Sapanisertib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Mar 23, 2017
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (sapanisertib, osimertinib)
    Patients receive sapanisertib PO QD on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 (day 1 is omitted in cycle 1). Patients also receive osimertinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose of sapanisertib in combination with osimertinib in patients with EGFRmutant (m) non-small cell lung cancer (NSCLC) [ Time Frame: 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in New Haven, CT

By research site
Smilow Cancer Center/Yale-New Haven Hospital· New Haven, CTYale University· New Haven, CTMoffitt Cancer Center· Tampa, FL

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