Advanced Non-Small Cell Lung Cancer (AJCC Stage IIIB-IV)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Histologically/cytologically confirmed AJCC stage IIIB-IV NSCLC; 3. Received first-line systemic therapy containing PD-1/PD-L1 ICI (single agent/chemo-combo/anti-angiogenic combo/dual ICI); 4. Confirmed disease progression (PD) per RECIST 1.1 after first-line ICI; 5. ECOG PS 0-2 at progression date; 6. Liver/renal function meet clinical standard cut-offs; 7. Initiated subsequent systemic anti-tumor therapy within 90 days after progression.
Exclusion criteria
Exclusion criteria: 1. EGFR/ALK/ROS1 mutations positive; 2. Active systemic autoimmune disease requiring long-term medication; 3. Primary progression within 4 weeks of first-line ICI initiation; 4. Only best supportive care without systemic anti-tumor treatment post-progression; 5. Over 30% missing key baseline variables; 6. Concurrent other active malignant tumor within 5 years (exclusive cured non-melanoma skin cancer, cervical carcinoma in situ).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (post-progression OS);Post-progression Progression-Free Survival (PFS2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-progression Objective Response Rate (ORR2);Time To Next Treatment (TTNT);Incidence of Grade =3 Treatment-Related Adverse Events; | — |
Countries
China
Contacts
The Fourth Affiliated Hospital, Zhejiang University School of Medicine