Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer (NCT06109402) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer
China160 participantsStarted 2023-12-20
Plain-language summary
For resectable non-small cell lung cancer, neoadjuvant immunochemotherapy plus adjuvant immunotherapy or adjuvant immunochemotherapy is usually used in clinical practice. However, it is unclear whether therapeutic strategy is superior. This trial aims to compare the efficacy and safety of these two strategies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient shall sign the Informed Consent Form.
✓. Aged 18 ≥ years.
✓. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-IIIB (N2) confirmed by imageological examinations (CT, PET-CT or EBUS).
✓. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
✓. Life expectancy is at least 12 weeks.
✓. At least 1 measurable lesion according to RECIST 1.1.
✓. Patients with good function of other main organs (liver, kidney, blood system, etc.)
✓. Patients with lung function can tolerate surgery;
Exclusion criteria
✕. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
✕. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
✕. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
What they're measuring
1
3-year event-free survival (EFS) rate
Timeframe: Up to 48 months
Trial details
NCT IDNCT06109402
SponsorShanghai Pulmonary Hospital, Shanghai, China