Status:
RECRUITING
Postoperative EGFR-TKI Therapy forContralateral Pulmonary Nodules in Patients With EGFR-Mutant NSCLC（ARMOR2501）
Lead Sponsor:
Sun Yat-sen University
Conditions:
Lung Cancer (NSCLC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Background Synchronous multifocal primary lung cancer (sMPLC) presents a therapeutic challenge, particularly for bilateral lesions. While surgical resection is standard for unilateral sMPLC, bilateral...
Detailed Description
1. Background Lung cancer is the most prevalent and deadliest malignancy worldwide. It is estimated that 0.2%-20% of lung cancer patients have synchronous multiple primary lung cancer (sMPLC) at the t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06924398
Start Date
April 20 2025
End Date
December 31 2025
Last Update
June 10 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060