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

Artificial Intelligence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541251
• Other study ID #: 2020-KY-061-001
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2021
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Herui Yao, PhD
• Phone: 18218018525
• Email: yaoherui[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-small Cell
• Lung Neoplasms

Intervention

Drug:
• Camrelizumab + Nab-paclitaxel + Carboplatin
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.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangdong Provincial People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

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