A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EG… (NCT03567642) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers
United States11 participantsStarted 2018-06-12
Plain-language summary
The purpose of this study is to test the safety of combining Osimertinib with either Cisplatin or Carboplatin (at different dose levels) and Etoposide, to find out what effects, if any, this combination of drugs has on people with EGFR mutant 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:
* Written informed consent
* Advanced biopsy-proven metastatic non-small cell lung cancer
* Either have not started an EGFR TKI or may have started osimertinib within the last 9 weeks
* Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA
* Evidence of a concurrent P53 alteration by IHC or NGS on pre-treatment tumor biopsy or cfDNA
* Evidence of a concurrent RB1 alteration by IHC or NGS on pre-treatment tumor biopsy or cfDNA
* Must have a site of disease amenable to repeat biopsy and be willing to undergo a biopsy during treatment
* Measurable (RECIST 1.1) indicator lesion not previously irradiated
* Karnofsky performance status (KPS) ≥ 70%
* Age \>18 years old
* Ability to swallow oral medication
* Adequate organ function
* AST, ALT ≤ 3 x ULN
* Total bilirubin ≤ 1.5x ULN
* Creatinine ≤ 1.5x ULN OR calculated creatinine clearance ≥ 60ml/min
* Absolute neutrophil count (ANC) ≥ 1000 cells/mm\^3
* Hemoglobin≥8.0 g/dL
* Platelets ≥100,000/mm\^3
Exclusion Criteria:
* Pregnant or lactating women
* Started an EGFR TKI other than osimertinib or started osimertinib more than 9 weeks ago
* Any radiotherapy within 1 week of starting treatment on protocol.
* Any major surgery within 1 weeks of starting treatment on protocol.
* Any evidence of active clinically significant interstitial lung disease
* Continue to have unresolved \> grade 1 toxicity from any previous treatment
* Have pure small cell histology
* Corrected QT interval …
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.