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

Aline Fusco Fares, MD

Status and phase

Enrolling

Phase 2

Conditions

Non-Small Cell Lung Cancer NSCLC

Lung Cancer, Nonsmall Cell

Treatments

Drug: Low-dose nivolumab combined with platinum-based doublet chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06667154

LungCancerLowDose

Details and patient eligibility

About

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.

Enrollment

33 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.