Trials / Unknown

UnknownNCT05451173

Combining ICI With SBRT or HypoFrx-RT for ES NSCLC

Combining an Immune Checkpoint Inhibitor With SBRT or Hypo-fractionated RT in the Treatment of Stage I-III NSCLC: an Exploratory Study on Radiation Dose and Treatment Efficacy.

Status: Unknown
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 83 (estimated)

Sponsor: Alexander Chi · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

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.

Detailed description

Patients will be assigned to Cohort A or Cohort B based on tumor stage (AJCC 8th Ed.). Cohort A: cT1-T3, N0, M0 (selected cT1, No, M0) Cohort B: cT4, N0, M0; cT1-4, N1-3, M0 Phase I: This portion of the study will utilize a standard 3 + 3 phase I design with three patients enrolled per radiation dose level in each cohort. Enrollment in the two cohorts is independent from one another. In both cohorts, an anti-PD-(L)1 immune checkpoint inhibitor will be given concurrently and adjuvantly with radiotherapy for approximately 1 year. The radiation dose escalation for each cohort is listed below: Cohort A (SBRT): (Optional): 8 Gy x 5 daily fractions Level 1: 9 Gy x 5 daily fractions Level 2: 10 Gy x 5 daily fractions Level 3: 11 Gy x 5 daily fractions Cohort B (HypoFrx-RT): (Optional): 3 Gy x 15 daily fractions Level 1: 3.5 Gy x 15 daily fractions Level 2: 4 Gy x 15 daily fractions DLTs will be based on events occurring during the course of radiotherapy. Concurrent administration of an immune checkpoint inhibitor is defined as: An anti-PD-(L)1 immune checkpoint inhibitor administered with standard dosing (Durvalumab: 1500 mg every 4 weeks) given within 5 days prior to the beginning of radiotherapy. Adjuvant administration of an immune checkpoint inhibitor is defined as: An anti-PD-(L)1 immune checkpoint inhibitor administered with standard dosing (Durvalumab: 1500 mg every 4 weeks) for approximately 1 year or until progression or other discontinuation criteria are met. Phase II: Once a maximum tolerated dose (MTD) is defined in each cohort, this dose will be used as the only radiation dose in each corresponding cohort in the phase II portion of this study. Dosing regimen of the immune checkpoint inhibitor will remain the same as that used in the phase I portion of this study. For this protocol, patients will be followed up to 2 years after the last dose of immune checkpoint inhibitor is administered.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2023-10-09
Primary completion: 2025-12-31
Completion: 2025-12-31
First posted: 2022-07-11
Last updated: 2023-10-03

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05451173. Inclusion in this directory is not an endorsement.