Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06667154

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

Led by Aline Fusco Fares, MD · Updated on 2024-10-31

33

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

Sponsors

A

Aline Fusco Fares, MD

Lead Sponsor

H

Hospital de Base

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide signed informed consent
  • Male or female aged 18 years or older
  • Diagnosed with non-small cell lung cancer (NSCLC) stages IB, II, or IIIA
  • Receiving treatment at Hospital de Base
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no recent decline
  • Tumor negative for EGFR gene expression
  • Tumor negative for ALK and ROS1 protein expression
  • PD-L1 protein expression documented and assessable
  • Tumor considered resectable by multidisciplinary thoracic oncology review
  • Adequate organ and bone marrow function: hemoglobin ≥ 9.0 g/dL, neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L without growth factor or transfusions
  • Serum bilirubin ≤ 1.5 x upper limit of normal (ULN), except Gilbert syndrome cases with physician approval
  • ALT and AST ≤ 2.5 x ULN
  • Creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
  • Life expectancy greater than six months prior to randomization
Not Eligible

You will not qualify if you...

  • Refusal to sign informed consent
  • NSCLC clinical stages IA, IIIB N3, IIIC, IVA, or IVB
  • Tumors invading aorta, esophagus, heart, or bulky N2 disease
  • Tumor deemed unresectable
  • Prior systemic anticancer therapy for NSCLC including chemotherapy, biologics, immunotherapy, or investigational drugs
  • History of other primary malignancies except those treated with curative intent and no active disease for ≥ 2 years, or treated non-melanoma skin cancer or carcinoma in situ with no evidence of disease
  • Incomplete medical information in electronic records
  • Tumor positive for EGFR gene expression
  • Tumor positive for ALK protein expression
  • No available PD-L1 protein expression data
  • Tumor positive for ROS1 protein expression
  • Pregnant or breastfeeding at enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, São Paulo, Brazil, 15090000

Actively Recruiting

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Research Team

J

JOAO A SOLER, MD

CONTACT

A

ALINE FARES, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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