Almonertinib after one‑lung surgery for suspected cancer nodules in the other lung of EGFR‑mutant NSCLC patients
Postoperative EGFR-TKI Therapy for High-Risk Synchronous Resectable Contralateral Pulmonary Nodules in Patients With EGFR-Mutant Non-Small Cell Lung Cancer（ARMOR2501）
This test tries whether three months of the EGFR blocker almonertinib can shrink or control suspected cancer nodules in the opposite lung of people with EGFR‑mutant non‑small cell lung cancer who already had one lung removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | almonertinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06924398 on ClinicalTrials.gov |
What this trial studies
This is an open‑label, single‑arm phase II trial enrolling 32 patients with synchronous bilateral primary NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations after unilateral resection. Participants start oral almonertinib 110 mg daily 4–10 weeks after surgery and receive three months of therapy targeting residual contralateral nodules. The primary endpoint is the rate of needing a second (contralateral) surgery within one year after treatment; secondary endpoints include tumor response rates, disease‑free and overall survival, safety, and whether surgery remains feasible after therapy. Imaging and clinical follow‑up will determine nodules’ radiographic response and subsequent management decisions.
Who should consider this trial
Good fit: Ideal candidates are patients with resected T1‑2N0M0 EGFR‑mutant (exon 19 del or exon 21 L858R) lung adenocarcinoma who have at least one contralateral suspected malignant nodule 8 mm–3 cm (pure GGNs >1 cm) unchanged after standard anti‑inflammatory treatment and who have adequate performance status.
Not a fit: Patients without EGFR‑sensitive mutations, with nodules outside the size or radiologic criteria, with more advanced or widespread disease, with poor performance status, or with contraindications to EGFR‑TKIs are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could reduce the need for a second lung operation and lower the risks and recovery burden associated with contralateral surgery.
How similar studies have performed: Third‑generation EGFR‑TKIs have shown clear benefit in metastatic and adjuvant EGFR‑mutant NSCLC and almonertinib has shown promising activity in early reports, but using it specifically to avoid contralateral surgery is a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1）Patients diagnosed with sMPLC (according to MM/ACCP clinical criteria). Preoperative chest CT (1mm slice thickness) reveals multiple bilateral lesions, all meeting surgical criteria \[≥8mm (pure ground-glass nodules (GGNs) must be \>1cm) and unchanged after standard anti-inflammatory treatment\]. 2）Patients received standard anti-inflammatory treatment before surgery. 3）The primary lesion in the operated lung is staged as T1-2N0M0. 4）Patients have undergone surgical resection of one side of the lung, with pathology confirming adenocarcinoma and an EGFR-sensitive mutation (exon 19 deletion or exon 21 L858R point mutation). 5）After unilateral resection, the contralateral lung must have at least one suspected malignant residual nodule \[≥8mm (pure GGNs must be \>1cm) and \<3cm, unchanged after standard anti-inflammatory treatment\], which must be confirmed as malignant by a qualified radiologist and thoracic surgeon. 6）ECOG performance status (PS) score of 0-1. Exclusion Criteria: * 1）Patients with lymph node metastasis or distant metastasis. 2）Patients with severe heart, lung, liver, or kidney dysfunction who cannot tolerate surgery. 3）Patients with a history of other malignancies within five years (except effectively controlled basal cell carcinoma, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and superficial bladder tumors). 4）Patients taking medications known to prolong the QTc interval or induce ventricular tachycardia who need to continue such medications during the study period. 5）Patients with a history of interstitial lung disease (ILD) or drug-induced ILD. 6）Patients with severe gastrointestinal dysfunction, diseases, or clinical symptoms that may affect drug intake, transport, or absorption. 7）Patients with active hepatitis B, hepatitis C, or HIV infections. 8）Pregnant or lactating women or women of childbearing potential who have not taken contraceptive measures. 9）Patients with uncontrolled neurological or psychiatric disorders or mental illnesses. 10）Patients participating in other clinical trials or expected to receive other anti-tumor treatments during this trial. 11）Other conditions deemed unsuitable for the study by the investigators
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hong Yang, PhD — Sun Yat-Sen University Cancer Center
- Study coordinator: Hong Yang, PhD
- Email: yanghong@sysucc.org.cn
- Phone: 86 13560405144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.