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Aumolertinib Combined With Phased Chemotherapy for EGFR L858R Lung Adenocarcinoma

NCT07624487 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-18

No results posted yet for this study

Summary

Background: While third-generation EGFR tyrosine kinase inhibitors (TKI) like aumolertinib have significantly improved outcomes for patients with advanced lung adenocarcinoma, those harboring the L858R mutation still experience inferior prognosis compared to those with exon 19 deletions. Recent evidence suggests that combining TKIs with chemotherapy improves progression-free survival (PFS), but universal application of this combination exposes all patients to cytotoxic toxicity, even those who might thrive on TKI monotherapy alone. Circulating cell-free DNA (cfDNA) and minimal residual disease monitoring offer a dynamic window to identify which patients truly require treatment intensification.

Objectives: The primary objective is to evaluate the predictive value of early molecular response by determining the association between the change in EGFR mutant allele fraction in cfDNA after a 6-week aumolertinib lead-in induction phase (T1) and a 4-cycle combination chemotherapy (T2) with clinical PFS. Secondary objectives include assessing overall response rates (ORR), disease control rate (DCR), safety, and the dynamics of EGFR mutant allele fraction and circulating immune cell profiles.

Study Design: This is a prospective, single-arm, multicenter, phase II clinical trial enrolling 50 evaluable patients. The study utilizes a three-phase treatment framework:

* Induction Phase: Aumolertinib monotherapy (110 mg/day) once daily for 6 weeks.
* Consolidation Phase: Combination of aumolertinib (110 mg/day) once daily with pemetrexed (500 mg/m²) and carboplatin (AUC 5) once every three weeks for 4 cycles.
* Maintenance Phase: Aumolertinib monotherapy once daily until disease progression.

Endpoints: The primary efficacy endpoint is Progression-Free Survival (PFS). Molecular efficacy will be measured via the Molecular Clearance Rate (MCR) and Molecular Response Rate (MRR) at baseline (T0), post-induction (T1), and post-chemotherapy (T2). Safety will be graded according to CTCAE v5.0.

Conclusion and Significance: This trial aims to establish a molecularly driven framework for personalized lung cancer management, seeking to maximize efficacy for high-risk patients while providing the foundation to spare molecular responders from unnecessary chemotherapy in the future. The results will serve as the base for the design of future confirmatory phase III trials.

Conditions

  • Lung Adenocarcinoma Metastatic

Interventions

DRUG

Aumolertinib combined with phased chemotherapy (pemetrexed and carboplatin)

phased and fixed-cycle combination chemotherapy versus FLAURA2 study (upfront and continuous combination chemotherapy)

Sponsors & Collaborators

  • Taipei Medical University

    collaborator OTHER

  • Taipei Medical University Hospital

    lead OTHER

Principal Investigators

  • Chao-Hua Chiu · Taipei Medical University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-09
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624487 on ClinicalTrials.gov