Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC (NCT03611738)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (19 items) and avoid the listed exclusions (22 items).
Location: Advent Health Orlando — Orlando, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Rearrangements in ALK.
- Activating mutations in EGFR.
- Potential participants with active malignancies other than NSCLC, or prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancers.
- Pregnant or breast feeding.
- Known hypersensitivity to ceritinib, docetaxel, or any of their excipients.
- Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.
- Has had major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to starting study treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions and patients can receive study treatment ≥1 week after these procedures.
- A history of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic intervention), including clinically significant radiation pneumonitis.
- Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia
- Concurrent use of other anticancer approved or investigational agents within 2 weeks of the first dose of study treatment.
- In taxane pretreated patents, any history of dose-limiting toxicity with prior taxane therapy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Advent Health Orlando — Orlando, Florida
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.