drugset / Trial / NCT04541251
Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC
Phase 2
Unknown
40 enrolled
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangdong Provincial People's Hospital · collabThird Affiliated Hospital, Sun Yat-Sen University · collab
NaSingle-groupOpen-labelTreatment
Summary
This prospective, single-arm, multicenter, phase II trial enrolled 40 patients who underwent surgery after three cycles of neoadjuvant therapy with camrelizumab, nab-paclitaxel, and carboplatin. The MPR is the primary endpoint, and the pCR, the complete resection rate, the objective response rate, the disease-free survival, adverse events, and quality of life are the secondary endpoints. The exploratory endpoints will be used to establish a multiomics artificial intelligence system for neoadjuvant therapy effect prediction and decision-making assistance based on radiomics, metabolism, genetic, and clinic-pathological characteristics and to explore drug resistance mechanisms.
Timeline
- Start
- 2020-08-01
- Primary completion
- 2022-07-30
- Completion
- 2023-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | — |
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Nab-paclitaxel | Small molecule | 260 mg/m2 | — |