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Non-small Cell Lung CancerPhase 1NCT03611738

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

A Phase 1 study testing Ceritinib and Docetaxel in people with Non-small Cell Lung Cancer and Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ceritinib and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesUnited States
Study dates
1 Feb 2019to Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Advent Health Orlando

    Orlando, Florida, 32804

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase I Study of Ceritinib Plus Docetaxel in ALK-Negative, EGFR WT Advanced NSCLC

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).

Read the detailed 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.

Being tested
Ceritinib, Docetaxel
Keywords
Advanced NSCLC, Advanced Non-small Cell Lung Cancer, anaplastic lymphoma kinase (ALK), ALK-negative, epidermal growth factor receptor (EGFR), wild-type (WT)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CeritinibDrug

    Also called Zykadia®, tyrosine kinase inhibitor

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

  • DocetaxelDrug

    Also called Taxotere®, intravenous microtubule inhibitor

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

Study groups in NCT03611738
Study groupRoleWhat they receive
Phase I Dose EscalationExperimentalThe design will recruit participants in cohorts of three patients each and will not allow for dose-skipping during escalation. A maximum of 18 participants will be enrolled for the phase I dose escalation. Three ceritinib dose levels have been identified for dose escalation (150 mg, 300 mg, and 450 mg), plus docetaxel at 75 mg. A backup dose (ceritinib 150 mg with docetaxel at 60 mg) is also prepared in case the three dose levels are too toxic. Therefore, four potential dose levels will be used for determination of maximum tolerated dose (MTD). The first cohort will start at dose level 1 (ceritinib 150 mg with docetaxel at 75 mg). Level -1 Backup Cohort: 150 mg ceritinib; 60 mg/m^2 docetaxel Level 1 Starting Cohort: 150 mg ceritinib; 75 mg/m^2 docetaxel Level 2 Cohort: 300 mg ceritinib; 75 mg/m^2 docetaxel Level 3 Cohort: 450 mg ceritinib; 75 mg/m^2 docetaxel
Receives: Drug: Ceritinib; Drug: Docetaxel
Phase Ib Dose ExpansionExperimentalTreatment at recommended dose. Investigators plan to have 30 patients for the expansion cohort. This will include participants from the dose escalation portion receiving the recommended dose.
Receives: Drug: Ceritinib; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Maximum Tolerated Dose (MTD)

    Maximum tolerated dose corresponding to a risk of dose limiting toxicity (DLT) occurring in 30% of patients.

    Measured: Up to 6 months

  2. Phase Ib: Overall Response (OR)

    OR: Defined as the participant being alive and the tumor size evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 on subsequent imaging assessment consistent with a complete response (CR) or partial response (PR). Overall response rates will be calculated with a 2-sided 95% confidence interval (CI). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm (< 1 cm). Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 30 months

Secondary outcomes (2)

  1. Progression-free Survival (PFS)

    PFS: Defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: Up to 30 months

  2. Overall Survival (OS)

    OS: Defined as the time from study entry to death due to any cause, will be summarized with the Kaplan-Meier curve.

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2018
  2. Study start1 Feb 2019
  3. Primary completion28 Apr 2025
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03611738
Sponsor's protocol ID
MCC-19656
Status last verified
May 2026
First submitted
27 Jul 2018
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ceritinib and Docetaxel in people with Non-small Cell Lung Cancer and Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Maximum Tolerated Dose (MTD) (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03611738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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