APL-101 for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MONon-Small Cell Lung CancerAPL-101 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Gemcitabine

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: At 1 year

At 1 year
Progression-free survival (PFS) (Phase II only)
Through 1 year follow-up
Overall survival (OS) (Phase II only)
Month 21
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)
Month 19
Maximum tolerated dose of APL-101 (MTD) (Phase I only)
Month 20
Duration of response (DOR) (Phase II only)
Objective response rate as measured by the proportion of participants achieving a confirmed complete response or partial response (Phase II only)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Pembrolizumab
1
Flt3/MerTK Inhibitor MRX-2843
1
Gemcitabine

Trial Design

3 Treatment Groups

Phase II: APL-101 + Standard of Care Osimertinib
1 of 3
Phase I Dose Level 2: APL-101 + Standard of Care Osimertinib
1 of 3
Phase I Dose Level 1: APL-101 + Standard of Care Osimertinib
1 of 3

Experimental Treatment

22 Total Participants · 3 Treatment Groups

Primary Treatment: APL-101 · No Placebo Group · Phase 1 & 2

Phase II: APL-101 + Standard of Care OsimertinibExperimental Group · 2 Interventions: APL-101, Osimertinib · Intervention Types: Drug, Drug
Phase I Dose Level 2: APL-101 + Standard of Care OsimertinibExperimental Group · 2 Interventions: APL-101, Osimertinib · Intervention Types: Drug, Drug
Phase I Dose Level 1: APL-101 + Standard of Care OsimertinibExperimental Group · 2 Interventions: APL-101, Osimertinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 year

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,822 Previous Clinical Trials
2,284,088 Total Patients Enrolled
Apollomics Inc.Industry Sponsor
5 Previous Clinical Trials
574 Total Patients Enrolled
Anjali Rohatgi, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
Siddhartha Devarakonda, MBBS, M.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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