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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Artificial Intelligence; Lung Cancer, Non-small Cell

Treatments: Drug: Camrelizumab + Nab-paclitaxel + Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04541251

2020-KY-061-001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Camrelizumab + Nab-paclitaxel + Carboplatin

Experimental group

Treatment:

Drug: Camrelizumab + Nab-paclitaxel + Carboplatin