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

NCT06667154 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-10-31

No results posted yet for this study

Summary

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

  • Lung Cancer, Nonsmall Cell
  • Non-Small Cell Lung Cancer NSCLC

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.

Sponsors & Collaborators

  • Hospital de Base de Sao Jose do Rio Preto

    collaborator UNKNOWN

  • Aline Fusco Fares, MD

    lead OTHER

Principal Investigators

  • JOAO A SOLER, MD · FUNDACAO FACULDADE REGIONAL DE MEDICINA DE SAO JOSE DO RIO PRETO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2025-10-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06667154 on ClinicalTrials.gov