NSCLC
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with unresectable or radiotherapy-resistant stage IIIB/IIIC or metastatic NSCLC confirmed by histology or cytology (using the 8th edition AJCC); 2. Disease progression after treatment with antibody-drug conjugates; 3. Sufficient post-progression tumor tissue samples must be provided at enrollment for NGS gene testing; 4. Able to understand and agree to comply with the study requirements and assessment schedule, and sign the informed consent form; 5. Aged 18 years or older at the time of signing the ICF.
Exclusion criteria
Exclusion criteria: 1. Patients who are unable to undergo tissue biopsy or for whom the tissue biopsy specimen is insufficient for NGS testing; 2. Patients with an ECOG score greater than 2, whom the investigator assesses to be unable to receive sequential anti-tumor therapy; 3. Patients who have not previously received antibody-drug conjugate therapy; 4. At the time of enrollment, all prior treatment-related toxicities (except for hair loss) must be grade 2 or lower; 5. Patients who received prior systemic anti-cancer treatment (chemotherapy, radiotherapy, biological therapy, vaccine therapy, or experimental treatment) within the last 2 weeks before the first administration of combination therapy, and received immune checkpoint inhibitor treatment within 4 weeks; 6. Any other underlying medical conditions that may be detrimental to, or potentially affect the interpretation of results, or that may place the patient at high risk of treatment-related complications, or reasons deemed by the investigator as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Molecular characteristics of NGS gene testing before and after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Countries
China
Contacts
Beijing Cancer Hospital