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Study Summary
This trial tests a new drug to see if it's safe & effective for advanced EGFR-mutant cancer patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My NSCLC has an EGFR mutation and doesn't fit other specific group criteria.I have not had radiation therapy in the last 4 weeks.My organs and bone marrow are working well.I am currently taking medication that strongly affects liver enzyme activity.I can perform daily activities with minimal assistance.My cancer has a specific EGFR mutation or another known driver.I have or had another type of cancer.I have had a serious lung condition that needed steroids.I have a digestive condition that could affect how my body absorbs medication.My lung cancer has a specific mutation and has spread to my brain or spinal cord.I have not had major surgery in the last 3 weeks.I haven't had serious heart problems in the last 6 months.My cancer has an EGFR mutation and has worsened despite standard treatments.I agree to use highly effective birth control during and for 3 months after treatment.I haven't had cancer treatment or experimental drugs in the last 2 weeks or 5 half-lives.My NSCLC has rare EGFR mutations not commonly targeted by current therapies.I am currently on medication for an infection.My NSCLC has EGFR ex20ins mutations and I haven't had targeted therapy for it.I have tested positive for HIV, HBV, or HCV.I have NSCLC with a mutation treatable by osimertinib and have received it.I am 18 years old or older.I do not have severe health issues like uncontrolled diabetes or mental health problems.My side effects from previous cancer treatments are mild or gone, except for hair loss or some nerve pain.My lung cancer has a specific EGFR mutation and affects my brain or spinal cord.
- Group 1: Part 1: NX-019 Dose Escalation
- Group 2: Part 2: NX-019 Dose Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the Part 2: NX-019 Dose Expansion protocol endorsed by FDA regulators?
"Due to the limited evidence backing its efficacy and safety, Part 2: NX-019 Dose Expansion was assigned a score of 1 on our team's scale from 1 to 3."
Is it currently possible to join the research program?
"Affirmative. Clinicaltrials.gov displays that this clinical trial is still collecting patients, with the initial post dating back to October 5th 2022 and a last edit on November 17th 2022. A total of 178 participants are anticipated from two different sites."
What is the population size of participants involved in this clinical experiment?
"Affirmative. Clinicaltrials.gov reveals that this clinical research, which was first published on October 5th 2022, is actively recruiting for 178 volunteers at 2 distinct centres."
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