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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The patients will receive three cycles (one cycle is defined as every 21 days +/- 3 days) of neoadjuvant therapy with camrelizumab 200 mg, nab-paclitaxel 260 mg/m2, and carboplatin AUC 5. This will then be followed by surgery.
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGMajor pathologic response (MPR) Rate
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.
Time frame: After surgery (approximately 10 weeks)
Evaluation of the pathological complete response (pCR)
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Time frame: After surgery (approximately 10 weeks)
Evaluation of complete resection (R0) rate
Proportion of patients with no residual resection margin under the microscope after tumor resection
Time frame: After surgery (approximately 10 weeks)
Disease free survival (DFS)
From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.
Time frame: 36 months
Overall survival (OS)
From the date of participated in study to the date of death.
Time frame: 36 months
Objective response rate(ORR)
The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery
Time frame: approximately 9 weeks
Adverse events (AEs)
The number of participants experiencing an AE will be assessed.An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined
Time frame: approximately 9 weeks
Serious adverse events (SAEs)
The number of participants experiencing an serious AE will be assessed
Time frame: approximately 9 weeks
Qol Quality of Life
Quality of life asscesed by Quality of Life Questionnare-Core 30(EORTC QLQ-C30）of The European O-rganization for Reasearch and Functional Assessment of Cancer Therapy-Lung (FACT-L)
Time frame: 36 months
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