Combining ICI With SBRT or HypoFrx-RT for ES NSCLC

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexander Chi
• Treatments: Durvalumab

Criteria

Inclusion Criteria:

Key Inclusion Criteria

1. Informed Consent

2. Stage IB-IIIC NSCLC per AJCC 8th. ed.

3. Tumor PD-L1 expression ≥1% preferred

4. Tumor sample submission

5. Tumor staging prior to registration

6. Age ≥ 18 years

7. WHO/ECOG PS of 0, 1, or 2

8. Life expectancy ≥12 weeks

9. Adequate organ or bone marrow function

10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

Exclusion Criteria:

Key Exclusion Criteria

1. Mixed small cell and non-small cell lung cancer histology

2. Definitive clinical or radiologic evidence of metastatic disease

3. Patients who received systemic therapy for the current cancer prior to enrollment

4. Thoracic radiotherapy within 5 years with exceptions

5. Major surgery within 28 days prior to enrollment with exception

6. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody

7. History of another primary malignancy with exceptions

8. 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

9. Active or prior documented autoimmune disease with exceptions

10. History of primary immunodeficiency

11. History of allogenic organ or tissue transplantation