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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer, Non-small Cell Artificial Intelligence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Camrelizumab + Nab-paclitaxel + Carboplatin

Group Type EXPERIMENTAL

Camrelizumab + Nab-paclitaxel + Carboplatin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No