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Combining ICI With SBRT or HypoFrx-RT for ES NSCLC

NCT05451173 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2023-10-03

No results posted yet for this study

Summary

This study will explore the best dose of radiation to be used when treating stage I-III non-small cell lung cancer (NSCLC) with stereotactic body radiation therapy (SBRT) or hypo-fractionated radiotherapy (HypoFrx-RT) that is delivered in combination with an immune checkpoint inhibitor. Treatments with SBRT or HypoFrx-RT for locally confined NSCLC show positive response which may be further augmented when they are combined with an immune checkpoint inhibitor. Currently, it is not understood what radiation dose is most suitable for such combined treatments and their clinical efficacy in the treatment of early stage (ES) NSCLC. Therefore, this study can help researchers gain insight into what a safe and effective SBRT or HypoFrx-RT dose will be when such radiotherapeutic approaches are combined with concurrent and adjuvant administration of an immune checkpoint inhibitor in the treatment of ES NSCLC.

Conditions

  • Non-small Cell Lung Cancer
  • Non-small Cell Carcinoma
  • Non-small Cell Lung Cancer Stage I
  • Non-small Cell Lung Cancer Stage II
  • Non-small Cell Lung Cancer Stage III

Interventions

RADIATION

Stereotactic body radiotherapy

An ablative dose of radiation is delivered to the primary tumor target over 1-2 week.

RADIATION

Hypofractionated radiotherapy

Hypofractionated radiotherapy is delivered to the primary tumor and any involved lymph node target(s) over 3 weeks.

DRUG

Durvalumab

an anti-PD-(L)1 immune checkpoint inhibitor is administered concurrently and adjuvantly with radiotherapy.

Sponsors & Collaborators

  • Alexander Chi

    lead OTHER

Principal Investigators

  • Alexander Chi, MD · Capital Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT05451173 on ClinicalTrials.gov