Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cell Lung Cancer (NCT02503722)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (31 items) and avoid the listed exclusions (44 items).
Location: Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Any serious intercurrent or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol including but not limited to:
- Uncontrolled diabetes mellitus (fasting plasma glucose \> 130 mg/dL or 7.2 mmol/L)
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
- Active infections
- Gastrointestinal disease limiting the ability to swallow oral medications or absorb oral medications including refractory nausea and vomiting, chronic gastrointestinal diseases, inflammatory bowel disease; malabsorption syndromes
- Patients with enteric stomata or significant bowel resection
- Prior history of corneal ulceration
- Patients with any evidence of severe or uncontrolled systemic liver disease including those with known hepatitis B and hepatitis C (excluding treated hepatitis C that has been cured)
- Active bleeding diatheses
- Significant active cardiovascular or pulmonary disease including:
- Uncontrolled hypertension (i.e., systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 95 mmHg); use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut
- Yale University — New Haven, Connecticut
- Moffitt Cancer Center — Tampa, Florida
- BCCA-Vancouver Cancer Centre — Vancouver, British Columbia
- University Health Network-Princess Margaret Hospital — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.