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

Primary Purpose

Lung Cancer, Non-small Cell, Artificial Intelligence

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Camrelizumab + Nab-paclitaxel + Carboplatin

About this trial

This is an interventional treatment trial for Lung Cancer, Non-small Cell focused on measuring Non-small cell lung cancer, Neoadjuvant therapy, Immune checkpoint inhibitor, Major pathological response, Artificial intelligence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-Sen Memorial Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab + Nab-paclitaxel + Carboplatin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Evaluation of complete resection (R0) rate

Proportion of patients with no residual resection margin under the microscope after tumor resection

Disease free survival (DFS)

From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.

Overall survival (OS)

From the date of participated in study to the date of death.

Objective response rate(ORR)

The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery

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

Serious adverse events (SAEs)

The number of participants experiencing an serious AE will be assessed

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)

Full Information

NCT ID

NCT04541251

First Posted

February 9, 2020

Last Updated

June 17, 2021

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

Guangdong Provincial People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT04541251

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

July 30, 2022 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

Guangdong Provincial People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Non-small Cell, Artificial Intelligence

Keywords

Non-small cell lung cancer, Neoadjuvant therapy, Immune checkpoint inhibitor, Major pathological response, Artificial intelligence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Camrelizumab + Nab-paclitaxel + Carboplatin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Camrelizumab + Nab-paclitaxel + Carboplatin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Major pathologic response (MPR) Rate

Description

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)

Secondary Outcome Measure Information:

Title

Evaluation of the pathological complete response (pCR)

Description

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)

Title

Evaluation of complete resection (R0) rate

Description

Proportion of patients with no residual resection margin under the microscope after tumor resection

Time Frame

After surgery (approximately 10 weeks)

Title

Disease free survival (DFS)

Description

From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.

Time Frame

36 months

Title

Overall survival (OS)

Description

From the date of participated in study to the date of death.

Time Frame

36 months

Title

Objective response rate(ORR)

Description

The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery

Time Frame

approximately 9 weeks

Title

Adverse events (AEs)

Description

Time Frame

approximately 9 weeks

Title

Serious adverse events (SAEs)

Description

The number of participants experiencing an serious AE will be assessed

Time Frame

approximately 9 weeks

Title

Qol Quality of Life

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Herui Yao, PhD

Phone

18218018525

yaoherui@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yunfang Yu, MD

yuyf9@mail.sysu.edu.cn

Facility Information:

Facility Name

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Herui Yao, PhD

Phone

+8618218018525

yaoherui@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Yunfang Yu, MD

Phone

+8618218018525

yuyf9@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

34992825

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.

Results Reference

derived

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

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