Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC

Phase 2

• Conditions: Lung Cancer, Non-small Cell; Artificial Intelligence
• Interventions: Drug: Camrelizumab + Nab-paclitaxel + Carboplatin

• Registration Number: NCT04541251
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-09
• Study Start: 2020-08-01
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-09
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-23
• Primary Completion: 2022-07-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab + Nab-paclitaxel + Carboplatin	Camrelizumab + Nab-paclitaxel + Carboplatin	-

Primary Outcome Measures

Name	Time	Method
Major pathologic response (MPR) Rate	After surgery (approximately 10 weeks)	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 Outcome Measures

Name	Time	Method
Objective response rate(ORR)	approximately 9 weeks	The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery
Evaluation of the pathological complete response (pCR)	After surgery (approximately 10 weeks)	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.
Evaluation of complete resection (R0) rate	After surgery (approximately 10 weeks)	Proportion of patients with no residual resection margin under the microscope after tumor resection
Serious adverse events (SAEs)	approximately 9 weeks	The number of participants experiencing an serious AE will be assessed
Disease free survival (DFS)	36 months	From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.
Adverse events (AEs)	approximately 9 weeks	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
Overall survival (OS)	36 months	From the date of participated in study to the date of death.
Qol Quality of Life	36 months	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)

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China