Clinical trial NCT04541251: Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer, Non-small Cell
Artificial Intelligence
Keywords: Non-small cell lung cancer
Neoadjuvant therapy
Immune checkpoint inhibitor
Major pathological response
Artificial intelligence
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2020-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major pathologic response (MPR) Rate
timeFrame: After surgery (approximately 10 weeks)
Secondary outcomes:
measure: Evaluation of the pathological complete response (pCR)
timeFrame: After surgery (approximately 10 weeks)
measure: Evaluation of complete resection (R0) rate
timeFrame: After surgery (approximately 10 weeks)
measure: Disease free survival (DFS)
timeFrame: 36 months
measure: Overall survival (OS)
timeFrame: 36 months
measure: Objective response rate(ORR)
timeFrame: approximately 9 weeks
measure: Adverse events (AEs)
timeFrame: approximately 9 weeks
measure: Serious adverse events (SAEs)
timeFrame: approximately 9 weeks
measure: Qol Quality of Life
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Zhou 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.