Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy

Trial Title: Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy

NCT ID: NCT06667154

Condition: Lung Cancer, Nonsmall Cell
Non-Small Cell Lung Cancer NSCLC

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Nivolumab

Conditions: Keywords:
Low Dose Immunotherapy
Neoadjuvant immunotherapy
Non-Small-Cell-Lung-Cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Low-dose nivolumab combined with platinum-based doublet chemotherapy
Description: Platinum-based neoadjuvant chemotherapy (carboplatin at AUC 5 or 6 combined with either paclitaxel at 175 mg/m² or pemetrexed at 500 mg/m²), administered with nivolumab at 0.3 mg/kg every 21 days for 3 cycles.
Arm group label: Low-dose nivolumab combined with platinum-based doublet chemotherapy

Summary: The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol. - Male or female, aged 18 years or older. - Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA. - Receiving treatment at Hospital de Base. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose. - Tumor sample meets the following requirements: - Negative for EGFR gene expression. - Negative for ALK and ROS1 protein expression. - PD-L1 protein expression documented and assessable. - Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review. - Adequate organ and bone marrow function as defined below: - Hemoglobin: ≥ 9.0 g/dL* - Absolute neutrophil count: ≥ 1.5 × 10^9 /L* - Platelet count: ≥ 100 × 10^9 /L* - *Note: Granulocyte colony-stimulating factor (G-CSF), platelet transfusions, and blood transfusions are not permitted to meet these values. - Serum bilirubin: ≤ 1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome, who may be included upon physician consultation. - ALT and AST: ≤ 2.5 × ULN. - Creatinine clearance: ≥ 50 mL/min (calculated using the Cockcroft and Gault formula). - Life expectancy greater than six months prior to randomization. Exclusion Criteria: - Refusal to sign the Informed Consent Form (ICF). - NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB. - Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease. - Tumor deemed unresectable. - Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs. - History of another primary malignancy, with exceptions for: - Malignancies treated with curative intent and no active disease for ≥ 2 years before the first dose of investigational product (IP) and with a low risk of recurrence. - Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease. - Adequately treated carcinoma in situ with no evidence of disease. - Incomplete basic medical information in the electronic medical record. - Positive for EGFR gene expression. - Positive for ALK protein expression. - No available data on PD-L1 protein expression. - Positive for ROS1 protein expression. - Pregnant or breastfeeding at the time of enrollment.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

Address:
City: Sao Jose Do Rio Preto
Zip: 15090000
Country: Brazil

Status: Recruiting

Start date: October 10, 2023

Completion date: October 31, 2027

Lead sponsor:
Agency: Aline Fusco Fares, MD
Agency class: Other

Collaborator:
Agency: Hospital de Base de Sao Jose do Rio Preto
Agency class: Other

Source: Fundação Faculdade Regional de Medicina de São José do Rio Preto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06667154