Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2
Conditions
Brief summary
This study is a multicenter, randomized, open-label, parallel-controlled clinical trial. It is designed to evaluate the efficacy and safety of Befotertinib versus Icotinib as first-line treatment in patients with previously untreated EGFR-sensitive mutation-positive locally advanced or metastatic non-small cell lung cancer with ECOG score ≥2.
Interventions
DRUGBefotertinib
befortertinib
DRUGIcotinib
Icotinib
Sponsors
Zhou Chengzhi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS | 9 weeks |
Secondary
| Measure | Time frame |
|---|---|
| ORR | 9 weeks |
Contacts
CONTACTChengzhi zhou Zhou
Outcome results
None listed