Last updated 52 days ago

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

33 patients around the world

Available in Brazil

Aline Fusco Fares, MD

1Research sites

33Patients around the world

This study is for people with

Lung cancer

Non-small cell lung carcinoma

From 18 Years

All Gender

: 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.

: 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.

Fundação Faculdade Regional de Medicina de São José do Rio Preto

Recruiting

Av. Brg. Faria Lima, 5544 Sao Jose do Rio Preto - Estado de São Paulo 15090-000

SponsorAline Fusco Fares, MD

Conditions

Non-small cell lung carcinoma

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06667154