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U3-1402 for Non-Small Cell Lung Cancer
Study Summary
This trial will study U3-1402, a new drug for treating non-small cell lung cancer. The study will evaluate safety and effectiveness in two parts: dose escalation and dose expansion.
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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Who is running the clinical trial?
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- You have any important irregularities in your resting electrocardiogram (ECG).My cancer has a specific EGFR mutation.My cancer biopsy shows small cell or mixed small cell and non-small cell features.I cannot or will not stop taking medications that may affect my heart's rhythm.I have factors that could cause heart rhythm problems.You have at least one specific area of your body that can be measured to see if the treatment is working.I don't have any health issues that could interfere with the study drug or affect my safety.I am currently taking a specific cancer medication but can stop if needed.I had a heart attack in the last 6 months.I have heart issues like failure, recent unstable angina, or arrhythmia needing treatment.I have or might have a lung condition called interstitial lung disease.I have a serious eye condition affecting my cornea.I am fully active or restricted in physically strenuous activity but can do light work.I haven't taken any cancer drugs or been in a trial recently.I have spinal cord compression or brain metastases needing steroids or seizure meds.I have been on erlotinib, gefitinib, afatinib, or osimertinib for 6+ weeks with manageable side effects.I have a condition where cancer has spread to the lining of my brain and spinal cord.My lung cancer cannot be cured with surgery or radiation.I benefited from EGFR treatment but my cancer progressed while still on it.I have been treated with erlotinib, gefitinib, or afatinib and do not have the EGFR T790M mutation.I have been treated with a platinum-based chemotherapy for my advanced cancer.My cancer progressed after treatment with an EGFR inhibitor.My cancer progressed despite treatment with specific lung cancer medications.My cancer has worsened after my last treatment.I have previously been treated with anti-PD-1 or anti-PD-L1 drugs for advanced cancer, unless I was unable or unwilling.Your blood pressure is very high, with the top number over 180 or the bottom number over 110.I have severe breathing problems due to lung illness.I can provide a recent biopsy sample or am willing to have a new biopsy if I've been treated with specific cancer drugs.My lung cancer is confirmed to be adenocarcinoma type.My lung cancer is confirmed by lab tests and does not have EGFR mutations.I haven't had any cancer except for certain skin, bladder cancers, or in situ disease treated to cure in the last 3 years.You have developed resistance to a specific type of medication for treating a certain gene mutation, as determined by specific criteria.Your heart's pumping ability is less than 50%, as shown by a heart ultrasound or a special heart imaging test.Your heart's electrical activity shows abnormal prolongation in three separate measurements.My lung cancer is confirmed to be adenocarcinoma type.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
How many locations are administering this experiment?
"This medical study is being conducted in the City of Hope located in Duarte, California; Winship Cancer Institute of Emory University situated inside Atlanta Georgia; and Seattle Cancer Care Alliance established in Seattle Washington. Additionally, there are 4 other trial sites currently being utilized."
What risks associated with U3-1402 are of most concern to researchers?
"Given the limited clinical data backing up U3-1402's safety and efficacy, our team at Power has scored it a 1 on its scale from 1 to 3."
Is enrollment for this clinical research ongoing?
"Affirmative, clinicaltrials.gov reveals that this study is actively enrolling individuals. It was first posted on October 30th 2017 and has been recently revised on July 5th 2022. The trial requires 264 participants to be recruited from 4 distinct sites."
How many participants are actively engaged in this research program?
"Affirmative. Clinicaltrials.gov indicates that this study is actively seeking subjects, first posted on October 30th 2017 and updated recently on July 5th 2022. A total of 264 patients must be recruited across 4 sites to complete the trial."
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