Ceritinib Plus Docetaxel in ALK-Negative EGFR WT Advanced NSCLC

  • STATUS
    Recruiting
  • End date
    Oct 28, 2024
  • participants needed
    48
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 28 January 2021
cancer
corticosteroids
lung cancer
metastasis
EGFR
brain metastases
docetaxel
leptomeningeal disease
taxotere
stage iv non-small cell lung cancer
lung carcinoma

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).

Description

In this phase I/IB clinical trial, participants with non-small cell lung cancer (NSCLC) who have progressed on prior platinum-based chemotherapy (maximum number of prior distinct regimens = 2) and are anaplastic lymphoma kinase (ALK)-negative/epidermal growth factor receptor (EGFR) wild-type (WT) will receive a combination of ceritinib and docetaxel.

Study rationale is that targeting ALK- and EGFR-negative lung tumors with ceritinib and microtubule inhibitors results in synergistic antitumor effects. Therefore, treatment with ceritinib and docetaxel is a rational combination.

Details
Condition Non-Small Cell Lung Cancer, Pulmonary Disease, Lung Neoplasm, Bronchial Neoplasm, Non Small Cell Lung Cancer Stage IIIB, Non Small Cell Lung Cancer Metastatic, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, Lung Cancer, Lung Disease, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, nsclc, carcinoma lung, lung carcinoma, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, EGFR Negative Non-Small Cell Lung Cancer
Treatment docetaxel, Ceritinib
Clinical Study IdentifierNCT03611738
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Lung Neoplasm or Bronchial Neoplasm or Non Small Cell Lung Cancer Stage IIIB or EGFR Negative Non-Small Cell Lung Cancer or Pulmonary Disease or Lung ...?
Do you have any of these conditions: Non Small Cell Lung Cancer Stage IIIB or nsclc or Stage IV Non-small Cell Lung Cancer or Lung Disease or lung carcinoma or EGFR Negative Non-Small Cel...?
Do you have any of these conditions: nsclc or Bronchial Neoplasm or Non Small Cell Lung Cancer Stage IIIB or Lung Disease or Non Small Cell Lung Cancer Metastatic or Pulmonary Disease or ...?
Do you have any of these conditions: Pulmonary Disease or Lung Neoplasm or Stage IV Non-small Cell Lung Cancer or Bronchial Neoplasm or Non Small Cell Lung Cancer Metastatic or Non Small ...?
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
- 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 management of brain metastases have been discontinued at least 7 days before registration to study
The brain metastases are stable on pre-registration imaging
There is no evidence of leptomeningeal disease
Measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Life expectancy > 3 months
Must have adequate organ and marrow function
Must have adequate laboratory values
Participants of child bearing potential must not be pregnant and must use established contraceptive strategies as outlined in the study protocol

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
A clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)
Uncontrolled diabetes mellitus, defined as fasting plasma glucose > 200 mg/dL
Impaired gastrointestinal (GI) function or GI disease that may alter absorption of ceritinib, or inability to swallow capsules
Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with ceritinib and for the duration of participation
Medication with a known risk of prolonging QT interval or inducing Torsades de Pointes
Strong inhibitors or strong inducers of CYP3A4/5 (see Appendix A for list)
Medications with a low therapeutic index that are primarily metabolized by CYP3A4/5, and/or CYP2C9
Therapeutic doses of warfarin sodium (Coumadin) or any other coumadin-derived anti-coagulant. Anticoagulants not derived from warfarin are allowed (e.g., dabigatran, rivaroxaban, apixaban)
Enzyme-inducing anticonvulsive agents
Herbal medications, including but not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng
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