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APL-101 + Osimertinib for Non-Small Cell Lung Cancer
Study Summary
This trial is testing a new drug, APL-101, in combination with osimertinib for patients with metastatic non-small cell lung cancer that is EGFR-mutated.
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?
Media Library
- I am 18 years old or older.I have had allergic reactions to similar medications used in this study.I am not taking any experimental drugs or herbal medicines.I have a lung condition that affects the tissue and space around the air sacs.I do not have severe diarrhea, nausea, or vomiting.I have not had major surgery in the last 30 days.I don't have severe side effects from previous treatments, except for manageable hormone issues.I do not have any uncontrolled illnesses or recent major heart issues.My blood and organ functions are within normal ranges.I've had immunotherapy or EGFR treatment for my cancer, but it's been over a year since my last treatment.I do not have uncontrolled fluid buildup in my chest or heart area, or if I do, it's managed with a chest tube.My condition did not improve with osimertinib treatment.I have a tumor that can be measured and biopsied.I can carry out all my self-care but cannot do heavy physical work.I am starting or have been on osimertinib for 8-16 weeks without my cancer getting worse.I have taken osimertinib for metastatic cancer, but not right before joining this trial.My heart does not pump blood well (ejection fraction below 50%).My lung cancer is advanced, cannot be cured with surgery, and has a specific EGFR mutation.I have brain metastases but am responding to treatment or have stable symptoms.
- Group 1: Phase I Dose Level 2: APL-101 + Standard of Care Osimertinib
- Group 2: Phase II: APL-101 + Standard of Care Osimertinib
- Group 3: Phase I Dose Level 1: APL-101 + Standard of Care Osimertinib
- 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
Are there other ongoing investigations using APL-101?
"Currently, 105 studies regarding APL-101 are still active with 17 of them being in Phase 3. While a concentration of the research for this topic is centred in Uniondale, New york, 4724 locations worldwide are conducting similar studies."
How many test subjects are a part of this research?
"The information on clinicaltrials.gov indicates that this study is still recruiting patients. The trial was first posted on 1/18/2022 and the most recent update was on 7/8/2022. 22 patients are needed for the study, which will take place at 1 location."
Are we still enrolling people for this research project?
"The correct. This study, as indicated by clinicaltrials.gov, is looking for participants right now. The first posting was on 1/18/2022 and the most recent update was on 7/8/2022. They need 22 individuals from 1 medical centre to take part in this trial."
Is this research the inaugural investigation of its type?
"APL-101 has undergone scientific study since 2013. The first clinical trial, sponsored by AstraZeneca, occurred that year with 603 participants. Based on the data collected, APL-101 received Phase 1 & 2 drug approval. As of now, there are 105 active trials involving this medication in 1061 cities and 51 countries."
What is the primary goal of this research?
"This study will last for 1 year and assess toxicity levels in patients. The maximum tolerated dose (MTD) of the medication will be determined in phase I, while objective response rate and duration of response (DOR) will be measured in phase II."
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