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

NCT04541251 | Unknown Phase 2

• 1 other identifier: 2020-KY-061-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer, Non-small Cell; Artificial Intelligence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Evaluation of the pathological complete response (pCR)

  After surgery (approximately 10 weeks)

• Evaluation of complete resection (R0) rate

  After surgery (approximately 10 weeks)

• Disease free survival (DFS)

  36 months

• Overall survival (OS)

  36 months

• Objective response rate(ORR)

  approximately 9 weeks

Study Arms (1)

Camrelizumab + Nab-paclitaxel + Carboplatin

EXPERIMENTAL

Drug: Camrelizumab + Nab-paclitaxel + Carboplatin

Interventions

Camrelizumab + Nab-paclitaxel + Carboplatin DRUG

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.

Camrelizumab + Nab-paclitaxel + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Guangdong Provincial People's Hospital: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34992825 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab; 130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Herui Yao, PhD

CONTACT

18218018525; yaoherui@mail.sysu.edu.cn

Yunfang Yu, MD

CONTACT

yuyf9@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: September 9, 2020
• Study Start: August 1, 2020
• Primary Completion: July 30, 2022
• Study Completion: September 30, 2023
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)