Almonertinib after one‑lung surgery for suspected cancer nodules in the other lung of EGFR‑mutant NSCLC patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.