Actively Recruiting
Postoperative EGFR-TKI Therapy forContralateral Pulmonary Nodules in Patients With EGFR-Mutant NSCLC（ARMOR2501）
Led by Sun Yat-sen University · Updated on 2025-06-10
32
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background Synchronous multifocal primary lung cancer (sMPLC) presents a therapeutic challenge, particularly for bilateral lesions. While surgical resection is standard for unilateral sMPLC, bilateral surgery carries high perioperative risks. This study evaluates postoperative adjuvant therapy with almonertinib, a third-generation EGFR-TKI, to reduce secondary surgery rates by targeting residual contralateral lesions in EGFR-mutant NSCLC patients. Objective * Primary: Assess the secondary surgery rate within one year after three months of almonertinib therapy. * Secondary: Evaluate tumor response (ORR, EGFR-TKI response rate), survival outcomes (DFS, OS), treatment safety, and surgical feasibility post-therapy. Study Design * Phase: Single-arm, open-label, phase II trial. * Population: 32 patients with bilateral sMPLC (EGFR exon 19 deletion/L858R mutations) after unilateral resection. * Intervention: Oral almonertinib (110 mg/day) for three months, initiated 4-10 weeks post-surgery. * Endpoints: * Primary: Proportion requiring secondary surgery due to lesion persistence/progression. * Secondary: ORR (RECIST 1.1), DFS, OS, adverse events (CTCAE v5.0), and safety of delayed surgery. * Inclusion Criteria: * sMPLC diagnosis (MM/ACCP criteria), T1-2N0M0 primary lesion, residual contralateral nodules (≥8 mm, confirmed malignant). * ECOG 0-1, age 18-75 years, compliance with follow-up. * Exclusion Criteria: Metastasis, severe organ dysfunction, prior malignancies (5 years), or concurrent QT-prolonging drugs. Statistical Analysis * Sample size calculated (α=0.05, power=0.95) to detect a reduction in secondary surgery rate from 100% (baseline) to 90%, accounting for 10% dropout. * Survival analysis via Kaplan-Meier curves and Cox regression; descriptive statistics for response rates. Safety Monitoring • Adverse events graded by CTCAE v5.0, including interstitial lung disease (ILD), cardiac toxicity, and laboratory abnormalities. Dose adjustments (55 mg) or discontinuation mandated for grade ≥3 events. Ethics and Compliance * Conducted per Good Clinical Practice (GCP) and Declaration of Helsinki. * Informed consent required; independent review committee (IRC) evaluates imaging outcomes. Expected Outcomes * Almonertinib may reduce secondary surgery rates by suppressing residual lesions, supported by prior efficacy in NSCLC (median PFS: 19.3 months in AENEAS trial). * Results will inform postoperative management strategies for bilateral sMPLC. Timeline Enrollment and preliminary efficacy analysis to conclude by December 2025. Conclusion ARMOR2501 aims to validate almonertinib's role in minimizing repeat surgeries for EGFR-mutant sMPLC, balancing efficacy and safety. Successful outcomes could establish a novel adjuvant paradigm for high-risk patients.
CONDITIONS
Official Title
Postoperative EGFR-TKI Therapy forContralateral Pulmonary Nodules in Patients With EGFR-Mutant NSCLC（ARMOR2501）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with synchronous multifocal primary lung cancer (sMPLC) with multiple bilateral lesions meeting surgical criteria (≥8mm or pure GGNs >1cm) unchanged after standard anti-inflammatory treatment
- Received standard anti-inflammatory treatment before surgery
- Primary lung lesion staged as T1-2N0M0
- Underwent surgical resection of one lung side with pathology confirming adenocarcinoma and EGFR-sensitive mutation (exon 19 deletion or exon 21 L858R)
- Contralateral lung has at least one suspected malignant residual nodule (≥8mm or pure GGNs >1cm and <3cm), confirmed malignant by qualified specialists
- ECOG performance status score of 0-1
- Aged between 18 and 75 years
- Capable of oral medication and able to comply with follow-up
- Willing to participate and provide informed consent
- Expected survival of more than three months and able to tolerate postoperative EGFR-TKI therapy
You will not qualify if you...
- Presence of lymph node or distant metastasis
- Severe heart, lung, liver, or kidney dysfunction preventing surgery
- History of other malignancies within five years, except certain controlled cancers
- Taking medications that prolong QTc interval or cause ventricular tachycardia requiring continuation during the study
- History of interstitial lung disease or drug-induced ILD
- Severe gastrointestinal dysfunction affecting drug intake or absorption
- Active hepatitis B, hepatitis C, or HIV infections
- Pregnant, lactating, or women of childbearing potential not using contraception
- Uncontrolled neurological or psychiatric disorders
- Participation in other clinical trials or planned anti-tumor treatments during this study
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hong Yang, PhD
CONTACT
Z
Zhichao Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here