Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC (NCT03611738) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC
United States21 participantsStarted 2019-02-01
Plain-language summary
The main purpose of this study is to find out what effects (good and bad) ceritinib (Zykadia®) used in combination with docetaxel (Taxotere®) will have on participants and their cancer. The results will help to determine the best safe dose of the combination of the medications Ceritinib (Zykadia®) and docetaxel (Taxotere®) and to find out if this combination of drugs will help people that have this type of Non-small Cell Lung Cancer (NSCLC).
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:
* Ability to understand and provide informed consent.
* Willingness and ability to comply with scheduled study visits and procedures.
* Adult men or women age ≥ 18 years.
* Histologic or cytologic diagnosis of advanced/metastatic Non-small Cell Lung Cancer (NSCLC), stage IIIB/IV.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* 1 - 3 (no more than three) prior regimens for stage IIIB/IV disease, with at least one prior regimen (for any stage) containing a platinum-based agent. One prior PD-1 or PD-L1 antibody-based regimen is allowable and counts as a prior regimen. Prior therapy with a taxane is allowed.
* Participants enrolled on the phase 1b expansion portion of the trial must be willing and able to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 3 months prior to initiation of treatment on Day 1, and must be obtained after most recent tumor progression. Participants for whom newly-obtained samples cannot be provided (e.g., inaccessible or participant safety concern) may submit an archived specimen only upon agreement from the Sponsor.
* Prior radiation is allowed if patients have recovered from side effects.
* Potential participants with a prior history of brain metastases are eligible, provided:
* The brain metastases have been treated
* The patient is asymptomatic from the brain metastases
* Corticosteroids prescribed for the ma…
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
Phase I: Maximum Tolerated Dose (MTD)
Timeframe: Up to 6 months
2
Phase Ib: Overall Response (OR)
Timeframe: Up to 30 months
Trial details
NCT IDNCT03611738
SponsorH. Lee Moffitt Cancer Center and Research Institute