A Clinical Study Comparing the Efficacy and Safety of Befotertinib Versus Icotinib in Patients With Previously Untreated EGFR-sensitive Mutation-positive Non-small Cell Lung Cancer With ECOG Score ≥2

Prior treatment

• Concurrent other malignancies (except cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, and papillary thyroid carcinoma).
  • Prior use of any systemic anti-tumor therapy for locally advanced or metastatic NSCLC, including systemic chemotherapy, immunotherapy, biotherapy, or targeted therapy.
  • Major surgery within 4 weeks before study drug treatment, except minor surgery judged by the investigator not to affect participation in the trial (e.g., tooth extraction); or planned major surgery during the study.
  • Significant worsening of symptoms or signs within 2 weeks before screening (e.g., massive pleural effusion within 2 weeks before screening; patients may be considered for screening after the effusion is controlled), and the investigator judges the patient unsuitable for the trial.

• Voluntarily sign written informed consent and be able to understand and comply with the protocol requirements.
  • Age ≥18 years at the time of signing informed consent.
  • Histologically or cytologically confirmed locally advanced (AJCC 9th edition stage IIIB and IIIC) or metastatic non-small cell lung adenocarcinoma (AJCC 9th edition stage IV), not suitable for radical surgery or radiotherapy. If the patient's performance status is assessed as unsuitable for obtaining biological samples, and the ECOG score is ≥3, a clinical diagnosis is acceptable.
  • No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; must have EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation, either alone or coexisting with other EGFR site mutations). For patients who have received local treatment more than 2 weeks prior, if the lesions within the local treatment field are non-target lesions, the patient may be enrolled.
  • Note: If a patient had previously completed radical surgery and adjuvant therapy for early-stage NSCLC but later experienced recurrence or metastasis, the patient may still be enrolled, provided that adjuvant therapy was completed more than 6 months before the first dose in this study.
  • ECOG performance status score ≥2.
  • Expected survival of at least 12 weeks.