non-small cell lung cancer
Conditions
Interventions
2-cycle treatment group:Platinum containing double drug combined with cindilimab for 2 cycles
4-cycle treatment group:Platinum containing dual drug combined with cindilimab for 4 cycles
Sponsors
The First Affiliated Hospital of Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Eastern Cooperation Group (ECOG) physical status score 0-1; 2. Participants have histologically proven stage IB, stage II and stage III non-small cell lung cancer (according to the 8th International Association for the Study of Lung Cancer (IASLC)); 3. According to the evaluation standard of solid tumor efficacy version 1.1 (RECIST 1.1), there are measurable lesions; 4. If all suspected mediastinal lymph nodes (including those with pathological enlargement or FDG concentration on PET/CT) can be examined by EBUS, thoracoscope or mediastinoscopy, further sampling is required for pathological confirmation; 5. Participants must have tumor tissue samples available for PD-L1 immunohistochemistry (IHC) examination (Dako 22C3 pharmDx platform); 6. The formalin fixed, paraffin embedded (FFPE) tissue block or unstained tumor tissue slice and corresponding pathological report must be submitted for evaluation of biomarkers before enrollment. Tumor tissue samples must be fresh or archived samples obtained within 3 months before enrollment; 7. The tissue must be the biopsy specimen of hollow needle puncture biopsy, resection or incision. The fine needle biopsy obtained by EBUS method is not sufficient for biomarker review and randomization. The hollow needle biopsy obtained by EBUS method can be used as a random basis.
Exclusion criteria
Exclusion criteria: 1. There is metastatic disease; 2. Active, known or suspected autoimmune disease; 3. Interstitial lung disease or pneumonia; 4. Have used any cancer related treatment in the past; 5. If participants with known EGFR mutation or ALK translocation are detected, they should use the detection method approved by NMPA and perform detection locally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response (MPR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Security;Objective Response Rate;Pathological complete response (pCR) rate;Disease-free survival (DFS); | — |
Countries
China
Contacts
Public ContactJian Hu
The First Affiliated Hospital of Medical College of Zhejiang University
Outcome results
None listed