Stage IV Lung Cancer AJCC v8 Clinical Trial
Official title:
A Ph1b Study of Osimertinib + Alisertib or Sapanisertib for Osimertinib-Resistant EGFR Mutant Non-Small Cell Lung Cancer (NSCLC) (Crossover Study)
This phase Ib trial studies the best dose, safety, and effect of alisertib or sapanisertib, in combination with osimertinib, in treating patients with EGFR mutated stage IIIB or IV non-small cell lung cancer that does not respond to osimertinib treatment (osimertinib resistant). Osimertinib, alisertib, and sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This study has two parts. The goal of part 1 of this trial is to find the highest tolerable dose of alisertib or sapanisertib in combination with osimertinib that can be safely given to patients with EGFR mutated non-small cell lung cancer. The goal of part 2 of this trial is to learn if the dose of alisertib or sapanisertib found in part 1 can help control EGFR mutated non-small cell lung cancer when given in combination with osimertinib.
PRIMARY OBJECTIVES: I. Determine the safety and the recommended phase 2 dose (RP2D) of osimertinib plus alisertib II. Determine the safety and the recommended phase 2 dose (RP2D) of osimertinib plus sapanisertib. SECONDARY OBJECTIVES: I. Determine the objective response rate (ORR) to the study combinations (osimertinib+alisertib and osimertinib+sapanisertib) in osimertinib-resistant EGFR mutant non-small cell lung cancer (NSCLC). II. Determine the progression free survival of the study combinations (osimertinib+alisertib and osimertinib+sapanisertib) in osimertinib-resistant EGFR mutant NSCLC. III. Determine the disease control rate (DCR) of the study combinations (osimertinib+alisertib and osimertinib+sapanisertib) in osimertinib-resistant EGFR mutant NSCLC. IV. Explore biomarkers associated with response/resistance of the study combinations (osimertinib+aliertib and osimertinib+sapanisertib) in osimertinib-resistant EGFR mutant NSCLC. OUTLINE: This is a dose-escalation study of alisertib or sapanisertib in combination with osimertinib, followed by a dose expansion study. Patients are assigned to 1 of 2 arms. ARM A: Patients receive osimertinib orally (PO) once daily (QD) on days 1-28 and alisertib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease may crossover to Arm B. ARM B: Patients receive osimertinib PO QD on days 1-28 and sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease may crossover to Arm A. After completion of study treatment, patients are followed up at 30 days. ;
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