Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer
This phase I trial studies the side effects and best dose of brigatinib and binimetinib in treating patients with stage IIIB-IV non-small cell lung cancer and a type of gene mutation called a rearrangement in the ALK or ROS1 genes. Brigatinib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 17, 2022 · 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 1
- Sponsor
- University of California, San Francisco
- Interventions being studied
- Drug: Binimetinib; 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.
- Participants must have histologically or cytological confirmed stage IIIB/IV NSCLC
- Documented ALK-rearrangement (or ROS1- rearrangement) break-apart fluorescence in situ hybridization (FISH) (in \>= 15% or tumor cells), or next generation sequencing assay performed on tumor sample or cell free DNA in a Clinical Laboratory Improvement Act (CLIA)-approved laboratory
- At least one prior ALK or ROS1 targeted tyrosine kinase inhibitor (TKI). With progression or intolerance of most recent regimen
- Dose Escalation Phase Only: At least one prior ALK or ROS1 targeted TKI. With progression or intolerance of most recent regimen.
- Dose Expansion Phase Only: In addition to the criteria in
- # 3, ALK+ patients with no prior chemotherapy, immunotherapy, radiation therapy or other systemic therapy are also allowed.
- Measurable or evaluable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Age \>= 18 years
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Leukocytes \>= 3,000/microliter (mcL)
- Absolute neutrophil count \>=1,500/mcL
- Platelets \>= 75,000/mcL
- Hemoglobin (Hgb) \>= 9 gm/dL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =\< 5 x institutional upper limit of normal
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =\< 5 x institutional upper limit of normal if there are liver metastases
- Creatinine within normal institutional limits OR
- Creatinine clearance \>= 50 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal
- Female participants who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of the study drugs, or
- Agree to completely abstain from heterosexual intercourse
- Male participants, even if surgically sterilized (i.e., status post-vasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of the study drugs, or
- Agree to completely abstain from heterosexual intercourse
- Negative pregnancy testing required at screening and cycle 1 day 1 for women of childbearing potential
- Ability to understand a written informed consent document, and willingness to sign it
- Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
- Participant is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)
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 California, San FranciscoSan Francisco, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 17, 2022. Always confirm current availability with the study team.