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Gilteritinib for the Treatment of ALK NSCLC

ConditionsLung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments. While there are many approved targeted drugs for ALK NSCLC, resistance to these drugs frequently occur. Giltertinib is a drug that is already FDA approved for the treatment of a specific type of leukemia. However, studies using ALK positive lung cancer cells demonstrate activity of gilteritinib against these resistant cells. Therefore, in this clinical trial, the investigators plan to study the effect of giltertinib in patients with ALK NSCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stage IV (American Joint Committee on Cancer [AJCC] 8th edition) non-small cell lung cancer with an oncogenic ALK fusion

Histologies include adenocarcinoma, squamous cell carcinoma, adenosquamous adenocarcinoma, and NSCLC NOS (not otherwise specified)

The presence of an oncogenic ALK fusion established from any Clinical Laboratory Improvement Act (CLIA) certified laboratory

The patient must belong to one of the following treatment cohorts.

Disqualifiers

Received palliative radiation within 7 days of enrollment

Received prior therapy with a FLT3 inhibitor

Has a concurrent active malignancy receiving interventional therapy unless it is the investigator's opinion that the concurrent active malignancy will NOT significantly impact the survival of the patient (i.e. early stage breast cancer or prostate cancer on hormonal therapy, basal cell carcinoma awaiting Moh's or other surgery and the respective interventional therapy does NOT interact or interfere with gilteritinib.

Has known active and symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo tissue biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Echocardiography

    Procedure/Surgery

    Undergo echocardiography

  • Gilteritinib

    Drug

    Given PO

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment (gilteritinib)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Safety will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Time frame
Up to 30 days after last dose of gilteritinib
2

Dose-limiting toxicities (DLT)

Toxicities will be assessed by CTCAE v 5.0. DLT's will be defined as \>= grade 4 hematologic toxicities, \>= grade 3 febrile neutropenia, \>= grade 3 non-hematologic toxicities, and posterior reversible encephalopathy syndrome of any grade. Toxicity will be quantified by reporting the proportion of patients who experience a DLT at the identified maximum tolerated dose and by reporting a 95% confidence interval for this proportion.

Time frame
Cycle 1 day 1 up to cycle 2 day 1 (each cycle is 21 days)

Secondary outcomes

1

Anti-tumor response

Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. Best responses including complete response, partial response, stable disease and progressive disease will be determined by independent radiology assessment.

Time frame
Up to 2 years after last dose of gilteritinib
2

Progression-free survival (PFS)

Determined by RECIST v 1.1.

Time frame
From start of treatment to time of progression, assessed up to 2 years after last dose of gilteritinib
3

Overall survival (OS)

Median OS and associated 95% confidence intervals will be assessed and reported using the Kaplan-Meier method.

Time frame
Cycle 1 day 1 of study start to date of death from any cause, assessed up to 2 years from last dose of gilteritinib

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan Rogel Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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