Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive Non-Small Cell Lung Cancer(NSCLC）
Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive NSCLC: A Prospective, Randomized Controlled Phase II/III Clinical Trial
Sponsor: Shanghai Chest Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR)
Time frame: up to 7 weeks after standard subsequent-line therapy
Progression-free survival (PFS)
Time frame: up to 3 years
Secondary Endpoints
Overall survival (OS)
Local Control (LC)
Adverse Events (AE)
Eligibility Criteria
Inclusion Criteria: 1. Sign a written informed consent form and voluntarily participate in this study; 2. Age 18-75 years; 3. ECOG 0-1, or able to tolerate radiotherapy/surgery and subsequent systemic therapy; 4. For Epidermal Growth Factor Receptor (EGFR)-sensitive mutant non-squamous NSCLC patients, first-line treatment must be the third-generation TKIs or progression after first/second-generation TKI without harboring T790M mutation, with ≤3 progressive lesions and ≤3 metastatic organs (PET-CT + cranial MRI preferred, or comprehensive imaging assessment, pathological examination not mandatory); 5. For squamous cell lung cancer patients, progression after first-line immunotherapy/chemotherapy-immunotherapy with ≤3 progressing lesions and ≤3 metastatic organs (PET-CT + cranial MRI preferred, or comprehensive imaging assessment, pathological examination not mandatory); 6. Expected survival ≥6 months; 7. No severe medical conditions; 8. Normal major organ functions, including: 1. B…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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