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Combining SBRT and Immunotherapy in Early Stage NSCLC Patients Planned for Surgery

NCT03446911 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-02-27

No results posted yet for this study

Summary

This study aims to evaluate the safety and mechanisms of action of the trimodality treatment (radiotherapy, immunotherapy and surgery) in early-stage non-small cell lung cancer. Half of the patients will receive stereotactic ablative radiotherapy followed by 2 cycles of immunotherapy (pembrolizumab); the other half will not receive the immunotherapy treatment. After treatment, both groups will continue treatment according to guidelines and will undergo surgery (lobectomy).

Conditions

  • NSCLC, Stage I

Interventions

RADIATION

SABR

Prior to surgery (lobectomy), patients receive stereotactic ablative radiotherapy.

COMBINATION_PRODUCT

SABR + pembrolizumab

Prior to surgery (lobectomy), patients receive stereotactic ablative radiotherapy + 2 rounds of pembrolizumab

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • E.F. Smit, MD, PhD · The Netherlands Cancer Institute

  • A.J. de Langen, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2020-05-31
Completion
2020-05-31

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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 NCT03446911 on ClinicalTrials.gov