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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights

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.

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 below
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

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 more

Trial 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
~1010

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,732 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

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04743505 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Phase I Dose Level 2: APL-101 + Standard of Care Osimertinib, Phase II: APL-101 + Standard of Care Osimertinib, Phase I Dose Level 1: APL-101 + Standard of Care Osimertinib
Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT04743505 — Phase 1 & 2
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743505 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
2022. "Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04743505.
~14 spots leftby Sep 2027
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