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An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer

NCT05500092 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-01-28

No results posted yet for this study

Summary

An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer

Conditions

  • Resectable Stage IIA to IIIB Non-small Cell Lung Cancer

Interventions

DRUG

Nivolumab

Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor

RADIATION

(8gy x 3)

sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor

DRUG

Platinum Doublet

Standard of care doublet platinum therapy

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Penn State University

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Brendon Stiles, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2025-07-01
Completion
2030-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT05500092 on ClinicalTrials.gov