Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer (NCT04085315) | Clinical Trial Compass
CompletedPhase 1
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
United States23 participantsStarted 2019-11-12
Plain-language summary
This phase I/Ib trial studies the side effects and best dose of alisertib when given together with osimertinib in treating patients with EGFR-mutated stage IV lung cancer. Alisertib may stop the growth of tumor cells by blocking a specific protein (Aurora Kinase A) that researchers believe may be important for the growth of lung cancer. Osimertinib may reduce tumor growth by blocking the action of a certain mutant protein (EGFR). This study may help researchers test the safety of alisertib at different dose levels in combination with osimertinib, and to find out what effects, good and/or bad, it has on EGFR-mutated lung cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must have histologically confirmed stage IV non-small cell lung cancer.
. Male or female patients \>=18 years of age
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
. Documented activating EGFR mutation (Exon 19 deletion, Exon 19 insertion, E709K, G719X, S768I, V769L, T790M, L833F, L833V, V834L, H835L, L858R, A859S, K860I, L861Q, A871E, V843I, or H870R) on tumor sample or cell-free DNA sample performed in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory.
. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
. Clinical laboratory values as specified below within 7 days before the first dose of study drug (if applicable):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of Maximum Tolerated Dose (MTD) (Cohort A)
Timeframe: First 28 days of study treatment (1 cycle is 28 days)
2
Proportion of patients experiencing dose limiting toxicity (DLT) (Cohort A)
Timeframe: First 28 days of study treatment (1 cycle is 28 days)
3
Proportion of patients experiencing serious adverse event (SAE)
. Radiation therapy to more than 25% of the bone marrow. Whole pelvic radiation is considered to be over 25%.
. Prior allogeneic bone marrow or organ transplantation
. Known Gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib. Examples include, but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease
. Inability to swallow oral medication or inability or unwillingness to comply with the administration requirements related to alisertib.
. Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen.
. Requirement for constant administration of proton pump inhibitor, Histamine 2 (H2) antagonist, or pancreatic enzymes throughout the study. The intermittent use of H2-antagonists and antacids (including carafate) is only allowed within these guidelines:
. H2 antagonists until Day -1 and after the dosing of alisertib is done
. Antacid formulations until 2 hours before dosing and after 2 hours following dosing.