Updated June 2026 · ClinicalTrials.gov
Postoperative EGFR-TKI Therapy forContralateral Pulmonary Nodules in Patients With EGFR-Mutant NSCLC（ARMOR2501）
Postoperative EGFR-TKI Therapy for High-Risk Synchronous Resectable Contralateral Pulmonary Nodules in Patients With EGFR-Mutant Non-Small Cell Lung Cancer（ARMOR2501）
Postoperative EGFR-TKI Therapy forContralateral Pulmonary Nodules in Patients With EGFR-Mutant NSCLC（ARMOR2501） (NCT06924398) is a Phase 2 interventional studying Lung Cancer (NSCLC), sponsored by Sun Yat-sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.
About This Trial
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.
What Stage of Research Is This?
Phase 2 trials evaluate whether a treatment actually works against Lung Cancer (NSCLC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.
This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.
With a target enrollment of 32 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.
Who May Be Eligible (Plain English)
These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Postoperative EGFR-TKI Therapy
A total of 32 patients with bilateral operable sMPLC will be prospectively enrolled. After unilateral tumor resection and confirmation of EGFR mutation positivity, they will be included in the study. Before formal enrollment, participants must be completely free from perioperative complications or have recovered from any complications. Enrolled patients will undergo baseline follow-up within 4 to 10 weeks postoperatively and start a three-month EGFR-TKI treatment on the same day. Patients will receive a CT follow-up at the end of the three-month treatment period. If they experience intolerable treatment-related adverse effects, EGFR-TKI treatment will be discontinued. If the lesion persists after three months, a multidisciplinary team will determine whether to proceed with surgical treatment.
Locations (1)
Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.
How to Talk to Your Doctor About This Trial
Bring the printable summary of this trial — including the NCT ID (NCT06924398), the sponsor (Sun Yat-sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.
Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.
Authoritative Sources
The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.
Frequently Asked Questions
What is the NCT06924398 clinical trial studying?
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 res… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.
Who can participate in NCT06924398?
Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.
How do I contact the trial site for NCT06924398?
Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.
Is participating in a clinical trial safe?
Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.
Where can I verify the data on this page?
Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.
How This Page Is Built
Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.
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Source: ClinicalTrials.gov API v2 record for NCT06924398. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06924398. Data: ClinicalTrials.gov."
Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
Last updated 2026-06-26 · Data from ClinicalTrials.gov.