Trial of Brigatinib After Treatment With Next-Generation ALK Inhibitors
The purpose of this study is to evaluate the safety and effectiveness of this investigational drug, brigatinib (AP261136) in patients with advanced non-small cell lung cancer Non-small cell lung cancer (NSCLC) who have had first-line treatment for their cancer and it still got worse, even after, or while taking drugs called ALK inhibitors, or anti-cancer drugs that act on tumors. Some examples of these anti-cancer drugs are: KEYTRUDA® or ALECENSA®).
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Checked against the public recordLast updated Jan 26, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Criterium, Inc.
- Interventions being studied
- Drug: brigatinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Locally advanced or metastatic NSCLC that has been cytologically or histologically confirmed ALK rearrangement based on FDA approved test (e.g. Vysis breakapart FISH or IHC using Ventana) ECOG PS ≤2 Age of ≥ 18 years Brain lesions may be used as target lesions if progressing, ≥10mm in longest diameter and if they were not previously treated with any of the following:
- Whole brain radiation therapy (WBRT) within 3 months
- Stereotactic radiosurgery (SRS)
- Surgical resection Availability of core biopsy of progressive lesion taken within 60 days prior to D1 of treatment under study therapy or willing to undergo tumor biopsy: NOTE:. All subjects must consent to provide tumor blocks or slides.
- If archival tissue is not available and biopsies to obtain fresh tumor tissue cannot be performed with minimal risk to the subject, subjects may be permitted to enroll on the study with prior approval of the Study PI.
- In the situation the patient undergoes biopsy within 60 days prior to D1. and there is insufficient tumor tissue subjects for the correlative science part of the protocol patient will be permitted to enroll on the study with prior approval of the study PI
- In the situation the patient undergoes molecular testing or next-generation sequencing as part of standard care there must be sufficient tumor sample available for participation in the study (i.e. a next generation sequencing report is not sufficient for enrollment) Recovered from toxicities related to prior anticancer treatment to ≤Grade 2 or baseline with the exception of alopecia Have normal QT interval on ECG evaluation QT corrected Fridericia (QTcF) of ≤ 450 ms in males or ≤ 470 ms in females Adequate organ function defined as: Absolute neutrophil count (ANC) ≥1500/µL Platelets ≥75,000/µL Hemoglobin≥ 10g/dL AST /ALT ≤ 2.5 x upper limit of normal (ULN); ≤ 5 x ULN if liver metastasis Total serum bilirubin ≤ 1.5 x ULN Serum creatinine ≤ 1.5 x UNL Serum amylase ≤ 1.5 x UNL At least 1 measurable lesion per RECIST version 1.1 Negative serum pregnancy test within 7 days of D1 of treatment in women of child bearing potential (WOCBP) If fertile, willing to use highly effective form of contraception (defined as a combination of at least two of the following methods: condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during the dosing period and for at least 4 months after Ability to provide signed informed consent and willing and able to comply with all study requirements Inclusion criteria for cohort assignment: Cohort A: Progressive disease on any next generation ALK inhibitor except first line alectinib or brigatinib (any line) Cohort B: Progressive disease on first-line therapy with alectinib, and no other ALK inhibitors Cohort C: Previous treatment brigatinib at 180 mg daily for ≥4 weeks without \> grade 2 drug-related toxicities and with radiographic evidence of progressive disease and no intervening systemic therapies such as chemotherapy, immunotherapy or another ALK inhibitor (radiation therapy allowed as intervening therapy). Patients who are treated on cohorts A and B will be allowed to enroll in cohort C if the meet the inclusion and
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University Of ColoradoDenver, Colorado
- Duke UniversityDurham, North Carolina
- Vanderbilt Unversity Medical CenterNashville, Tennessee
- University of Texas, SouthwesternDallas, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 26, 2023. Always confirm current availability with the study team.