- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04541251
Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC
June 17, 2021 updated by: Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
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 Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Herui Yao, PhD
- Phone Number: 18218018525
- Email: yaoherui@mail.sysu.edu.cn
Study Contact Backup
- Name: Yunfang Yu, MD
- Email: yuyf9@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510120
- Recruiting
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
-
Contact:
- Herui Yao, PhD
- Phone Number: +8618218018525
- Email: yaoherui@mail.sysu.edu.cn
-
Contact:
- Yunfang Yu, MD
- Phone Number: +8618218018525
- Email: yuyf9@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major pathologic response (MPR) Rate
Time Frame: 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.
|
After surgery (approximately 10 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the pathological complete response (pCR)
Time Frame: 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.
|
After surgery (approximately 10 weeks)
|
Evaluation of complete resection (R0) rate
Time Frame: After surgery (approximately 10 weeks)
|
Proportion of patients with no residual resection margin under the microscope after tumor resection
|
After surgery (approximately 10 weeks)
|
Disease free survival (DFS)
Time Frame: 36 months
|
From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.
|
36 months
|
Overall survival (OS)
Time Frame: 36 months
|
From the date of participated in study to the date of death.
|
36 months
|
Objective response rate(ORR)
Time Frame: approximately 9 weeks
|
The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery
|
approximately 9 weeks
|
Adverse events (AEs)
Time Frame: 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
|
approximately 9 weeks
|
Serious adverse events (SAEs)
Time Frame: approximately 9 weeks
|
The number of participants experiencing an serious AE will be assessed
|
approximately 9 weeks
|
Qol Quality of Life
Time Frame: 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)
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Anticipated)
July 30, 2022
Study Completion (Anticipated)
September 30, 2023
Study Registration Dates
First Submitted
February 9, 2020
First Submitted That Met QC Criteria
September 4, 2020
First Posted (Actual)
September 9, 2020
Study Record Updates
Last Update Posted (Actual)
June 23, 2021
Last Update Submitted That Met QC Criteria
June 17, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- 2020-KY-061-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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