Combining ICI With SBRT or HypoFrx-RT for ES NSCLC

Sponsor
Alexander Chi
Study ID
NCT05451173
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Stereotactic body radiotherapy — RADIATION
    An ablative dose of radiation is delivered to the primary tumor target over 1-2 week.
  • Hypofractionated radiotherapy — RADIATION
    Hypofractionated radiotherapy is delivered to the primary tumor and any involved lymph node target(s) over 3 weeks.
  • Durvalumab — DRUG
    an anti-PD-(L)1 immune checkpoint inhibitor is administered concurrently and adjuvantly with radiotherapy.

Study Details

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.

Key Dates

Start date
Oct 9, 2023
Status verified
Sep 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
83 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    SBRT to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor.
  • Experimental: Cohort B
    Hypo-fractionated radiotherapy to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 2 years ]

Central Contacts

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