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 range18 Years
SexALL
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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…
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