Targeted drug shows promise for Gene-Driven lung cancers
NCT ID NCT04084717
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests the drug crizotinib (XALKORI) in people with advanced non-small cell lung cancer that has spread and carries a change in the ROS1 or MET gene. Participants take crizotinib by mouth twice daily. The study aims to see how well the drug shrinks tumors and delays cancer growth, while also tracking side effects and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- crizotinib (XALKORI)
- What this could lead to
- If successful, this could provide an effective treatment option for people with advanced lung cancer driven by ROS1 or MET gene changes.
- What could go wrong
- This is a small, early-phase study, so results may not apply to all patients. Crizotinib can cause side effects like nausea, vision problems, and liver issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
33 people
The number who actually took part.
- Started
-
Dec 2019
- Finished
-
Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of stage IV or incurable non-squamous non-small cell lung cancer with a documented ROS1 rearrangement (cohort 1) or MET-activating mutation (exon 14) (cohort 2) or MET-amplification (cohort 3) tested in either plasma or tissue, as applicable * 18 years of age or older. * Measurable disease as per RECIST v1.1. * Adequate hematologic and organ function within 7 days of the proposed start date of treatment and adequate cardiac function within 28 days of the proposed start date of treatment * Life expectancy \>12 weeks. * Have the ability to understand and the willingness to sign a written informed consent document * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * No contraindication to Crizotinib therapy * Able to swallow and retain oral 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. * No pregnant * Agree to use methods (as agreed upon by the study doctor and participant) before the study and for at least 120 days after the last dose of study drug to prevent pregnancy Exclusion Criteria: * Symptomatic untreated brain metastases. * Had chemotherapy (including investigational cytotoxic chemotherapy), biologic agents (e.g. targeted therapy or antibodies) within 4 weeks or radiotherapy within 2 weeks prior to the proposed first dose of study treatment. * Adverse events attributed to prior anti-cancer therapy \> Grade 1 if clinically relevant. * Receiving medications or substances known to be strong inhibitors or inducers of CYP3A4. * Any known intolerance to agents structurally similar to crizotinib. * Congenital long QT syndrome or persistent corrected QT interval by Fredericia formula (QTcF) ≥ 500 msec. * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Four-Drug cocktail shrink Hard-to-Treat lung tumors?