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Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC

NCT03611738 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-05-15

No results posted yet for this study

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).

Conditions

  • Non-small Cell Lung Cancer
  • Lung Cancer
  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Stage IIIB
  • Stage IV Non-small Cell Lung Cancer
  • EGFR Negative Non-Small Cell Lung Cancer

Interventions

DRUG

Ceritinib

Ceritinib daily by mouth (PO) with food, according to the dosage schedule outlined in the treatment arm.

DRUG

Docetaxel

Docetaxel intravenously (IV) every 3 weeks, according to the dosage schedule outlined in the treatment arm.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Andreas Saltos, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2025-04-28
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03611738 on ClinicalTrials.gov