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Tyrosine Kinase Inhibitor
APL-101 + Osimertinib for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Led By Siddhartha Devarakonda, MBBS, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age
Normal bone marrow and organ function as defined below: Absolute neutrophil count ≥ 1,500/mcL, Platelets ≥ 100,000/mcL, Hemoglobin ≥ 9 g/dL (transfused Hgb allowed), Total bilirubin ≤ 1.5 mg/dL or ≤ 26 µmol/L, AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal (IULN) (≤ 5.0 x IULN if liver metastases), Creatinine ≤2 x IULN or Creatinine clearance calculated by Cockcroft-Gault formula ≥60 ml/min, Serum calcium (after correcting for albumin level) ≤ IULN, Serum phosphorus ≤ IULN
Must not have
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to APL-101, osimertinib, or other agents used in the study
Currently receiving any other investigational agents or herbal medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
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.
Who is the study for?
Adults with EGFR-mutated metastatic non-small cell lung cancer who've been on osimertinib for 8-16 weeks without disease progression. They must have measurable disease, good organ function, and an ECOG performance status ≤ 1. Participants need to agree to use contraception and cannot be pregnant or breastfeeding. Exclusions include allergic reactions to similar compounds, uncontrolled illnesses, recent major surgery, prior certain treatments for cancer, heart failure, unresolved toxicities from previous treatments, gastrointestinal disorders, interstitial lung disease or symptomatic brain metastases.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of APL-101 combined with osimertinib in patients whose non-small cell lung cancer has not progressed after initial treatment with osimertinib alone. The dose of APL-101 will increase until the maximum tolerated dose is found; then more patients will receive this dose alongside standard osimertinib treatment.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immune therapies such as fatigue, digestive issues like nausea or diarrhea (which must be controlled before joining), liver enzyme changes requiring normal function at start, potential blood count variations needing specific levels at baseline. Specific side effects of APL-101 are not detailed but would likely align with common targeted therapy adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My blood and organ functions are within normal ranges.
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I have a tumor that can be measured and biopsied.
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I can carry out all my self-care but cannot do heavy physical work.
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My lung cancer is advanced, cannot be cured with surgery, and has a specific EGFR mutation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had allergic reactions to similar medications used in this study.
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I am not taking any experimental drugs or herbal medicines.
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I have a lung condition that affects the tissue and space around the air sacs.
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I do not have severe diarrhea, nausea, or vomiting.
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I have not had major surgery in the last 30 days.
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I do not have any uncontrolled illnesses or recent major heart issues.
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My condition did not improve with osimertinib treatment.
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My heart does not pump blood well (ejection fraction below 50%).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) (Phase II or received MTD only)
Toxicity as measured by number of study discontinuations due to treatment-related adverse events (Phase I only)
Toxicity as measured by number of study treatment related adverse events (Phase I only)
Secondary outcome measures
Duration of response (DOR) (Phase II or received MTD only)
Maximum tolerated dose of APL-101 (MTD) (Phase I only)
Objective response rate as measured by the proportion of participants achieving a confirmed complete response or partial response (Phase II or received MTD only)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase II: APL-101 + Standard of Care OsimertinibExperimental Treatment2 Interventions
After 8-16 weeks of osimertinib, patients will be imaged as per standard of care. If imaging does not show disease progression, patients will continue on to study treatment with the combination of osimertinib and APL-101.
APL-101 is an oral drug which will be administered on an outpatient basis at the assigned dose (this dose will be determined in Phase I of the study) twice daily on Days 1 through 28 of each 28-day cycle
Osimertinib is an oral drug which will be administered on an outpatient basis at a dose of 80 mg once daily on Days 1 through 28 of each 28-day cycle.
Group II: Phase I Dose Level 2: APL-101 + Standard of Care OsimertinibExperimental Treatment2 Interventions
After 8-16 weeks of osimertinib, patients will be imaged as per standard of care. If imaging does not show disease progression, patients will continue on to study treatment with the combination of osimertinib and APL-101.
APL-101 is an oral drug which will be administered on an outpatient basis at the assigned dose twice daily on Days 1 through 28 of each 28-day cycle
Osimertinib is an oral drug which will be administered on an outpatient basis at a dose of 80 mg once daily on Days 1 through 28 of each 28-day cycle.
Group III: Phase I Dose Level 1: APL-101 + Standard of Care OsimertinibExperimental Treatment2 Interventions
After 8-16 weeks of osimertinib, patients will be imaged as per standard of care. If imaging does not show disease progression, patients will continue on to study treatment with the combination of osimertinib and APL-101.
APL-101 is an oral drug which will be administered on an outpatient basis at the assigned dose twice daily on Days 1 through 28 of each 28-day cycle
Osimertinib is an oral drug which will be administered on an outpatient basis at a dose of 80 mg once daily on Days 1 through 28 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1050
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,534 Total Patients Enrolled
Apollomics Inc.Industry Sponsor
5 Previous Clinical Trials
727 Total Patients Enrolled
Siddhartha Devarakonda, MBBS, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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