Postoperative EGFR-TKI Therapy forContralateral Pulmonary Nodules in Patients With EGFR-Mutant NSCLC（ARMOR2501）

Launched by SUN YAT-SEN UNIVERSITY · Apr 6, 2025

Keywords

ClinConnect Summary

The ARMOR2501 clinical trial is studying a new treatment for patients with a specific type of lung cancer called EGFR-mutant non-small cell lung cancer (NSCLC) who have multiple tumors in both lungs. The goal is to see if taking a medication called almonertinib after surgery can help prevent the need for additional surgeries by targeting leftover cancer nodules in the lung that may still be there after the first surgery. This trial will include 32 patients who have undergone surgery for one lung's tumor but have remaining nodules in the other lung. Participants will take almonertinib for three months and will be monitored for how well it works and if it is safe.

To be eligible for this trial, patients must have a confirmed diagnosis of multiple lung tumors, have had surgery for one of them, and have specific mutations in their cancer. They should be between 18 and 75 years old and in good overall health. Throughout the study, participants will have regular check-ups to assess their response to the treatment and any side effects they may experience. This research aims to find out if this new approach can reduce the need for more surgeries, ultimately improving the management of this challenging condition.

Gender

ALL

Eligibility 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