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

NCT ID: NCT06667154

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2027-10-31

Brief 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.

Conditions

Lung Cancer, Nonsmall Cell; Non-Small Cell Lung Cancer NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-dose nivolumab combined with platinum-based doublet chemotherapy

Group Type: EXPERIMENTAL

Low-dose nivolumab combined with platinum-based doublet chemotherapy

Intervention Type: DRUG

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.

Interventions

Low-dose nivolumab combined with platinum-based doublet chemotherapy

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Base de Sao Jose do Rio Preto

UNKNOWN

Sponsor Role: collaborator

Aline Fusco Fares, MD

OTHER

Sponsor Role: lead

Responsible Party

Aline Fusco Fares, MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

JOAO A SOLER, MD

Role: PRINCIPAL_INVESTIGATOR

FUNDACAO FACULDADE REGIONAL DE MEDICINA DE SAO JOSE DO RIO PRETO

Locations

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

JOAO A SOLER, MD

Role: CONTACT

joao.soler@hbonco.org.br

+55 17 981350180

ALINE FARES, MD

Role: CONTACT

aline.fares@edu.famerp.br

Other Identifiers

LungCancerLowDose

Identifier Type: -

Identifier Source: org_study_id