Clinical trial · Interventional
Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC
Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Patients With Stage IB-IIIA Non-small Cell Lung Cancer (NANE-LC): A Prospective, Single-arm, Multicenter, Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence | — | UNRESOLVED | — |
| Lung Cancer, Non-small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab + Nab-paclitaxel + Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camrelizumab + Nab-paclitaxel + Carboplatin
- interventionNames
- Drug: Camrelizumab + Nab-paclitaxel + Carboplatin
Primary outcomes (1)
- measure
- Major pathologic response (MPR) Rate
- timeFrame
- After surgery (approximately 10 weeks)
- description
- MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Secondary outcomes (8)
- measure
- Evaluation of the pathological complete response (pCR)
- timeFrame
- After surgery (approximately 10 weeks)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * The patients have stage IB-IIIA NSCLC. * Patient ages are ≥ 18 years old, regardless of gender. * The patients have an ECOG ps of 0-1, with a condition suitable for surgery. * The patients have not received any anti-tumor treatment. * The patients have adequate blood function. * The patients have adequate organ function. * The patients had been using an appropriate method of contraception, and there exists a negative pregnancy test (serum or urine) for women. * The patients will give their signed informed consent. Exclusion criteria: * Patients who had a prior allogeneic tissue or organ transplantation. * Patients who have multiple cancers. * Patients who have any severe or uncontrolled systemic diseases. * Patients with a positive test for HIV, HBV, or HCV. * Patients with severe infection or with an infection that required antibiotic therapy. * Patients with a history of interstitial lung disease, active tuberculosis, or autoimmune disease. * Patients who have participated in any other clinical trials. * Patients who are considered ineligible by the investigator.
References
Publications (1)
- DERIVEDZhou H, Lin L, Qin T, Ren W, Tan Y, Yang Q, Xu H, Xie X, Chen Y, Liu S, Li X, Li Z, Hu H, Yu Y, Yao H. Neoadjuvant camrelizumab, nab-paclitaxel, and carboplatin in patients with stage IB-IIIA non-small cell lung cancer (NANE-LC): a study protocol of prospective, single-arm, multicenter, phase II study. J Thorac Dis. 2021 Nov;13(11):6468-6475. doi: 10.21037/jtd-21-1022. PMID 34992825