Non-small cell lung canccer
Conditions
Interventions
Study group(Combination therapy group):Patients received third-generation EGFR-TKI combined with platinum-based doublet chemotherapy as first-line treatment.
Control group(EGFR-TKI group):Patients received third-generation EGFR?TKI monotherapy as first?line treatment.
Sponsors
Jiangmen Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed non-small cell lung cancer (NSCLC); 2. Patients with concurrent EGFR and TP53 mutations confirmed by next-generation sequencing (NGS); 3. At least one measurable target lesion in the lung on imaging, defined in accordance with RECIST v1.1 (Response Evaluation Criteria in Solid Tumors); 4. Life expectancy of more than 3 months; 5. Age between 18 and 80 years; 6. No significant organ dysfunction; 7. Written informed consent for the use of antineoplastic agents must be signed prior to treatment.
Exclusion criteria
Exclusion criteria: 1. Concurrent or previously diagnosed with other malignant tumors; 2. EGFR exon 20 insertion mutation; 3. No severe infection (CTCAE grade > 2) occurred within 4 weeks prior to treatment, such as severe pneumonia, bacteremia, sepsis, tuberculosis, etc.; 4. Superior vena cava syndrome with contraindication to fluid infusion; 5. History of severe neurological or psychiatric disorders, including but not limited to depression, epilepsy, dementia, bipolar disorder, etc.; 6. Active autoimmune and inflammatory diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, psoriasis, inflammatory bowel disease, Hashimoto's thyroiditis, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Intracranial Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Intracranial Objective Response Rate;Disease Control Rate;Intracranial Disease Control Rate;Duration of Response;Intracranial Duration of Respon;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactLiu Dongying
Jiangmen Central Hospital
Outcome results
None listed