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Recruiting NCT06667154

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

Phase II Interventional Lung Cancer, Nonsmall Cell Non-Small Cell Lung Cancer NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose nivolumab combined with platinum-based doublet chemotherapy.
Who it may be relevant to
Registry conditions: Lung Cancer, Nonsmall Cell, Non-Small Cell Lung Cancer NSCLC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Major Pathologic Response [Time frame: 2-3 months]
  • Pathologic Complete Response [Time frame: 2-3 months]
Secondary outcome measures (3)
  • Adverse Events [Time frame: Up to 3 months after the end of treatment]
  • Event-Free-Survival [Time frame: Up to 60 months]
  • R0 resection [Time frame: Up to 3 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto — São José do Rio Preto

Identifiers

NCT: NCT06667154 · LungCancerLowDose

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗