26 Participants Needed

APL-101 + Osimertinib for Non-Small Cell Lung Cancer

AR
Siddhartha Devarakonda profile photo
Overseen BySiddhartha Devarakonda
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Washington University School of Medicine
Must be taking: Osimertinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

In this study, patients with metastatic non-small cell lung cancer that is EGFR-mutated, who have received at least 8 and not more than 12 weeks of treatment with osimertinib without demonstrating disease progression, will receive APL-101 in combination with osimertinib until progression. Dosing of APL-101 will be escalated until the maximum tolerated dose is determined, at which point 10 additional patients will be enrolled at that dose in the expansion cohort.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on other investigational agents or herbal medications. It's best to discuss your specific medications with the trial team.

What safety data exists for APL-101 + Osimertinib in humans?

Osimertinib, also known as Tagrisso, has been studied in various trials for non-small cell lung cancer and is generally well tolerated. Common side effects include diarrhea, rash, dry skin, and nail issues, with more severe side effects occurring in about 28% of patients. No new safety concerns have been identified in recent studies.12345

What makes the drug osimertinib unique for treating non-small cell lung cancer?

Osimertinib is a third-generation drug that targets specific mutations in non-small cell lung cancer, particularly the T790M mutation, which often causes resistance to earlier treatments. It is designed to be more effective and has a generally manageable side effect profile compared to older treatments.36789

What data supports the effectiveness of the drug combination APL-101 and Osimertinib for treating non-small cell lung cancer?

Osimertinib has been shown to be effective for patients with non-small cell lung cancer that have a specific mutation (EGFR T790M) and have progressed after previous treatments. It has demonstrated significant tumor response rates and prolonged progression-free survival in clinical trials.23589

Who Is on the Research Team?

AR

Anjali Rohatgi, M.D., Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The effects of APL-101 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of the study
My blood and organ functions are within normal ranges.
I have a tumor that can be measured and biopsied.
See 4 more

Exclusion Criteria

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.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment with Osimertinib

Participants receive osimertinib for 8-16 weeks to assess disease progression

8-16 weeks
Regular imaging as per standard of care

Combination Treatment

Participants receive APL-101 in combination with osimertinib until disease progression

Until progression
Outpatient visits every 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • APL-101
  • Osimertinib
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Phase II: APL-101 + Standard of Care OsimertinibExperimental Treatment2 Interventions
Group II: Phase I Dose Level 2: APL-101 + Standard of Care OsimertinibExperimental Treatment2 Interventions
Group III: Phase I Dose Level 1: APL-101 + Standard of Care OsimertinibExperimental Treatment2 Interventions

Osimertinib is already approved in United States, European Union for the following indications:

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Approved in United States as Tagrisso for:
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Approved in European Union as Tagrisso for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Apollomics Inc.

Industry Sponsor

Trials
6
Recruited
750+

Published Research Related to This Trial

In a study of 46 treatment-naive patients with EGFR-mutated advanced non-small cell lung cancer, alternating therapy with osimertinib and afatinib resulted in a median progression-free survival of 21.3 months, indicating promising efficacy despite not meeting the primary endpoint of 12-month progression-free survival probability.
The treatment was generally well-tolerated, with common side effects including diarrhea (73.9%) and rash (63.0%), and only a few cases of serious pneumonitis, suggesting a manageable safety profile for this alternating therapy approach.
Alternating therapy with osimertinib and afatinib for treatment-naive patients with EGFR-mutated advanced non-small cell lung cancer: A single-group, open-label phase 2 trial (WJOG10818L).Hayashi, H., Yonesaka, K., Nakamura, A., et al.[2022]
Osimertinib (Tagrisso) is a targeted therapy approved by the FDA for patients with metastatic non-small cell lung cancer (NSCLC) who have the EGFR T790M mutation and have progressed after previous treatments.
The drug received special designations from the FDA, including breakthrough therapy and priority review, highlighting its significance in treating resistant forms of NSCLC.
Targeting the Gatekeeper: Osimertinib in EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer.Skoulidis, F., Papadimitrakopoulou, VA.[2022]
Osimertinib (TAGRISSO) received accelerated FDA approval for treating metastatic non-small cell lung cancer with the EGFR T790M mutation, showing significant tumor response rates of 57% and 61% in two major trials involving 411 patients.
While osimertinib demonstrated promising efficacy, common side effects included diarrhea (42%) and rash (41%), with 28% of patients experiencing severe adverse events, highlighting the need for careful monitoring during treatment.
Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer.Khozin, S., Weinstock, C., Blumenthal, GM., et al.[2022]

Citations

Alternating therapy with osimertinib and afatinib for treatment-naive patients with EGFR-mutated advanced non-small cell lung cancer: A single-group, open-label phase 2 trial (WJOG10818L). [2022]
Targeting the Gatekeeper: Osimertinib in EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer. [2022]
Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer. [2022]
Osimertinib: First Global Approval. [2022]
Osimertinib as first-line therapy in advanced NSCLC: a profile of its use. [2020]
New Adjuvant Drug for Lung Cancer. [2023]
Osimertinib: A Review in Completely Resected, Early-Stage, EGFR Mutation-Positive NSCLC. [2022]
Effectiveness of osimertinib in patients with lung adenocarcinoma in clinical practice - the Expanded Drug Access Program in Poland. [2022]
Comprehensive analysis of circular RNA profiling in AZD9291-resistant non-small cell lung cancer cell lines. [2022]
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