Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

ClinicalTrials.gov ID: NCT04743505

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Official title

Phase I/II Study Exploring the Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04743505
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Washington University School of Medicine; Other
Enrollment: 27 participants

Conditions and interventions

Conditions

Metastatic Non Small Cell Lung Cancer

Interventions

APL-101 Drug
Osimertinib Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 18, 2022 (Actual)
Primary completion: Jan 31, 2027 (Estimated)
Completion: Dec 31, 2029 (Estimated)
Last update posted: Jan 20, 2026

2022 – 2029

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Washington University School of Medicine	St Louis	Missouri	63110	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04743505, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 20, 2026 · Synced Nov 11, 2026