BridgeMD
New treatment option for Non-small Cell Lung Cancer (NSCLC)
Official title A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT07140016
What this study is testing
What is gilteritinib?
gilteritinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer (nsclc).
Also referred to as ASP2215.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly.
- Phase 1: an early, usually small safety study
- Time commitment: about 4 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with a documented...
- Participant is willing to submit, prior to enrollment, a fresh tumor tissue sample that was collected after completion of the most recent anti-cancer...
- Participant must have at least one prior line of ALK inhibitor-based therapy and meet one of the following criteria:
- Participant received alectinib as the only prior ALK inhibitor regimen. Participant is ineligible or unable to tolerate approved and available...
- Participant received lorlatinib as one of the prior ALK inhibitor regimens.
You likely can't join if
- Participant has known oncogenic driver alterations other than ALK rearrangement.
- Participant has symptomatic central nervous system (CNS) metastases or leptomeningeal metastasis.
- Participant has a history of malignancy other than NSCLC within 2 years before screening (exceptions are squamous and basal cell carcinomas of the...
- Participant had major surgery (e.g., requiring general anesthesia) within 4 weeks prior to first dose of study intervention, or will not have fully...
- Participant has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior anti-cancer...
- Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection...
See the full eligibility criteria
Who can join
- Participant has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with a documented anaplastic lymphoma kinase (ALK) rearrangement and is not amenable to...
- Participant is willing to submit, prior to enrollment, a fresh tumor tissue sample that was collected after completion of the most recent anti-cancer treatment and before the first dose of study intervention. If it is...
- Participant must have at least one prior line of ALK inhibitor-based therapy and meet one of the following criteria:
- Participant received alectinib as the only prior ALK inhibitor regimen. Participant is ineligible or unable to tolerate approved and available second-line therapy or is determined to potentially benefit from...
- Participant received lorlatinib as one of the prior ALK inhibitor regimens.
- Participant has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been...
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Participant must have had progression or recurrence of NSCLC during or following receipt of the most recent therapy.
- Female participant is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP).
- WOCBP who has a negative urine or serum pregnancy test within 7 days prior to the first dose of study intervention and agrees to follow the contraceptive guidance from the time of informed consent through at least 180...
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 60 days after final study intervention administration.
- Female participant must not donate ova starting at the first administration of study intervention and throughout the investigational period and for 180 days after final study intervention administration.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 120 days after final study intervention...
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 120 days after final study intervention...
- Male participant must not donate sperm during the treatment period and for 120 days after final study intervention administration.
- Participant must meet the criteria as indicated on the clinical laboratory tests.
- Participant agrees not to participate in another treatment study while receiving study intervention in the present study/participating in the present study.
What rules you out
- Participant has known oncogenic driver alterations other than ALK rearrangement.
- Participant has symptomatic central nervous system (CNS) metastases or leptomeningeal metastasis.
- Participant has a history of malignancy other than NSCLC within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or malignancy considered cured...
- Participant had major surgery (e.g., requiring general anesthesia) within 4 weeks prior to first dose of study intervention, or will not have fully recovered from surgery, or has surgery planned during the study...
- Participant has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior anti-cancer treatment.
- Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to first dose of study intervention.
- Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.
- Participant has a history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York...
- Participant has a history of interstitial pneumonia.
- Participant had completed target therapy, radiotherapy, chemotherapy, biologics and/or immunotherapy within 14 days prior to first dose of study intervention.
- Participant requires treatment with strong inducers of cytochrome P450 (CYP) 3A.
- Participant requires treatment with concomitant drugs that target serotonin 5HT1 or 5HT2B receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the...
- Participant has received any investigational therapy within 14 days or 5 half-lives, whichever is longer, prior to screening.
- Participant has a mean Fridericia-corrected QT interval (QTcF) of \> 450 msec at screening.
- Participant has known active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen (HBsAg)-positive and/or anti-HBV core antibody-positive) or known active hepatitis C virus (HCV) infection (defined...
- Participant with HBsAg-positivity and/or anti-HBV core antibody-positivity but with a negative HBV DNA PCR assay is permitted with appropriate antiviral prophylaxis or routine monitoring according to local practice.
- Participant who has been curatively treated for HCV infection is permitted if he/she has documented sustained virologic response of 12 weeks.
- Participant has a known history of human immunodeficiency virus (HIV) infection with acquired immunodeficiency syndrome (AIDS)-related complications.
- Participant has echocardiogram (ECHO) or multigated acquisition scan (MUGA) at screening revealing left ventricular ejection fraction \< 45%.
- Participant has any condition that makes the participant unsuitable for study participation.
- Participant has a known or suspected hypersensitivity to gilteritinib or any components of the formulation used.
The study team makes the final eligibility decision.
Where it's taking place
- Fullerton, California, United States
- Orange, California, United States
- Atlanta, Georgia, United States
- Peoria, Illinois, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- Dallas, Texas, United States
- Fairfax, Virginia, United States
- Saint-Herblain, France
- Toulouse, France
- Villejuif, France
- Barcelona, Spain
- Madrid, Spain
- Málaga, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fullerton, California, United States; Orange, California, United States; Atlanta, Georgia, United States; Peoria, Illinois, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.