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

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: Guangdong Provincial People's Hospital; Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Carboplatin; Paclitaxel

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.