Analyzing the effects of low-dose nivolumab with chemotherapy for lung cancer treatment

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

This study is testing if a low dose of nivolumab combined with chemotherapy can help people with early-stage non-small cell lung cancer respond better to treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundação Faculdade Regional de Medicina de São José do Rio Preto (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (São José do Rio Preto, São Paulo)
• Trial ID: NCT06667154 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of low-dose nivolumab, an immunotherapy drug, combined with platinum-based chemotherapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC). The primary focus is to measure the major pathological response (MPR) and pathologic complete response (pCR) rates in participants. Eligible patients will undergo treatment at Hospital de Base, and their tumor samples will be assessed for specific genetic markers. The study aims to provide insights into the potential benefits of this neoadjuvant treatment approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with resectable stage IB, II, or IIIA non-small cell lung cancer who meet specific genetic criteria.

Not a fit: Patients with non-resectable tumors or those with positive EGFR, ALK, or ROS1 expressions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the response rates in patients with non-small cell lung cancer, potentially leading to better surgical outcomes.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in lung cancer, indicating potential for success in this trial.

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.

Where this trial is running

São José do Rio Preto, São Paulo

• Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto — São José do Rio Preto, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Joao a Soler, Md — Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
• Study coordinator: Joao a Soler, Md

Conditions Lung Cancer, Nonsmall Cell; Non-Small Cell Lung Cancer NSCLC; Low Dose Immunotherapy; Neoadjuvant immunotherapy; Non-Small-Cell-Lung-Cancer