Advanced non-small cell lung cancer
Conditions
Interventions
Drive-positive patients with advanced NSCLC:NA
Drive gene-negative advanced NSCLC patients:NA
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Study 1: 1. Age >= 18 years old, gender not limited; 2. ECOG PS score 0-3 points; 3. Patients diagnosed with primary NSCLC by histopathology; 4. Patients in stage IIIC and IV (8th edition TNM staging) who are inoperable or have relapsed or metastasized; 5. Molecular biology testing of tumor tissue confirms driver gene positivity (driver gene positivity includes but is not limited to the following test results: a) EGFR classic mutation positivity, including EGFR exon 19 deletion mutation (Ex19Del) or exon 21 L858R point mutation (L858R); b) EGFR rare mutation positive, including EGFR including G719X, L861Q, and S768I point mutations, as well as exon 20 insertion mutations; c) ALK rearrangement positive; d) RET gene fusion positive; e) ROS1 mutation positive; f) MET exon 14 jump mutation positive; g) BRAF V600 mutation positive; h) KRAS G12C mutation positive; i) HER2 mutation positive; j) Positive for other driver genes (such as TP53, GR M8, BA I3, ER BB4, RUNX1T1, KEAP1, FBXW7, FGFR1 amplification, SOX amplification, PIK3CA amplification, MDM2 amplification, PDGFR A amplification, P53 mutation, NRF2 mutation, PTEN, EPHA2 mutation, etc.); 6. Normal reading and writing abilities, with sound cognitive and behavioral abilities; 7. Voluntarily sign the informed consent form. Study 2: 1. Age >= 18 years old, gender not limited; 2. ECOG PS score 0-3 points; 3. Patients diagnosed with primary NSCLC by histopathology; 4. Patients in stage IIIC and IV (8th edition TNM staging) who are inoperable or have relapsed or metastasized; 5. Lung adenocarcinoma patients require molecular biology testing of tumor tissue to confirm negative driver genes (driver gene testing should include at least EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, and HER2); Patients with lung squamous cell carcinoma and other pathological types of NSCLC are not required to undergo genetic testing; 6. Normal reading and writing abilities, with sound cognitive and behavioral abilities; 7. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects currently participating in other clinical trials; 2. Those who are unable to cooperate in completing follow-up due to geographical or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free progression survival (PFS) of patients with advanced NSCLC; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events in patients with advanced NSCLC;Treatment mode and OS of patients with advanced NSCLC;Mark EORTC QLQ- LC13?Mark EORTC QLQ- C30; | — |
Countries
China
Contacts
Public ContactHuijuan Wang
Henan Cancer Hospital
Outcome results
None listed