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Stereotactic Ablative Radiotherapy With Nivolumab for Early-Stage Operable Non-Small Cell Lung Cancer

NCT04271384 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-12-26

No results posted yet for this study

Summary

Stage 1 non-small cell lung cancer (NSCLC) carries up to 30% chance of relapse in 5 years. This a phase 2 study that aims to determine the pathological complete response of the combination of stereotactic ablative radiotherapy (SABR) plus nivolumab as neoadjuvant treatment in early-stage non-small cell lung cancer. The patients will receive standard SABR + nivolumab at a dose of 360 mg every 21 days for 3 doses. The patient will undergo surgery 10 weeks after the last radiotherapy dose.

Conditions

  • Non-small Cell Lung Cancer Stage I

Interventions

COMBINATION_PRODUCT

nivolumab

Combined neoadjuvant therapy consisting of nivolumab + SABR

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Gustavo Schvartsman, MD, PhD · Hospital Israelita Albert Einstein

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2023-11-15
Completion
2023-11-15

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 NCT04271384 on ClinicalTrials.gov