Combining ICI With SBRT or HypoFrx-RT for ES NSCLC

NCT05451173 | Unknown Phase 1 DMC

• 1 other identifier: SF 2022-2-1042
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NSCLC, Stereotactic body radiotherapy, SBRT, Hypofractionated, Radiotherapy

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD)

  MTD in cohort A and cohort B, respectively.

  2 years

• The incidence of any adverse events that is >= grade 3

  Adverse events will be graded according to CTCAE v.5.0

  2 years

• Progression-free survival (PFS)

  PFS is defined as free from any disease progression or death after combined treatment for NSCLC.

  2 years

Secondary Outcomes (4)

• Local control

  2 years

• Overall survival (OS)

  2 years

• Quality of Life (QoL)

  2 years

• Quality of Life (QoL), Lung cancer specific

  2 years

Study Arms (2)

Cohort A

EXPERIMENTAL

SBRT to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor.

Radiation: Stereotactic body radiotherapy; Drug: Durvalumab

Cohort B

EXPERIMENTAL

Hypo-fractionated radiotherapy to be delivered with concurrent and adjuvant anti-PD-(L)1 immune checkpoint inhibitor.

Radiation: Hypofractionated radiotherapy; Drug: Durvalumab

Interventions

Stereotactic body radiotherapy RADIATION

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

Also known as: SBRT

Cohort A

Hypofractionated radiotherapy RADIATION

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

Also known as: HypoFrx-RT

Cohort B

Durvalumab DRUG

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

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent
• Stage I-III NSCLC per AJCC 8th. ed.
• Tumor PD-L1 expression ≥1% preferred
• Tumor sample submission
• Tumor staging prior to registration
• Age ≥ 18 years
• WHO/ECOG PS of 0, 1, or 2
• Life expectancy ≥12 weeks
• Adequate organ or bone marrow function
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

You may not qualify if:

• Mixed small cell and non-small cell lung cancer histology
• Definitive clinical or radiologic evidence of metastatic disease
• Patients who received systemic therapy for the current cancer prior to enrollment
• Thoracic radiotherapy within 5 years with exceptions
• Major surgery within 28 days prior to enrollment with exception
• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
• History of another primary malignancy with exceptions
• History of idiopathic pulmonary fibrosis, any pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on chest PET/CT or CT scan
• Active or prior documented autoimmune disease with exceptions
• History of primary immunodeficiency
• History of allogenic organ or tissue transplantation

Sponsors & Collaborators

• Alexander Chi: lead

Study Sites (1)

Capital Medical University Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; Radiation Dose Hypofractionation; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Dose Fractionation, Radiation; Radiotherapy Dosage

Study Officials

• Alexander Chi, MD

  Capital Medical University

  STUDY CHAIR

Central Study Contacts

Alexander Chi, MD

CONTACT

5718391855; achiaz2010@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Parallel assignment

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 11, 2022
• Study Start: October 9, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)