Safety and Tolerability of Low Dose Radiotherapy Concurrent SBRT and PD-1 Inhibitors in Advanced … (NCT05615142) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety and Tolerability of Low Dose Radiotherapy Concurrent SBRT and PD-1 Inhibitors in Advanced NSCLC.
China9 participantsStarted 2021-12-15
Plain-language summary
This pilot phase I trial aims to investigate the safety and tolerability of low dose radiotherapy (LDRT) and concurrent partial stereotactic body radiation therapy (SBRT) in combination with programmed cell death-1 (PD-1) inhibitors in Stage IV non-small cell lung cancer (NSCLC) patients who have failed standard therapy. At least 9 participants will be enrolled in this study. All will take part at West China Hospital, Sichuan University.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent/assent for the trial.
✓. Be ≥18 years of age on day of signing informed consent.
✓. Patients with histologically or cytologically confirmed stage IV NSCLC.
✓. Be willing to undergo repeat biopsy of tumor lesions according to the study protocol.
✓. Patients who have failed the standard therapy, or who are unsuitable for standard treatment, or refuse chemotherapy.
✓. At least one measurable lesion according to RECIST 1.1. A lesion that has previously received radiotherapy can be considered a target lesion only if this lesion is clearly progressed after radiotherapy.
✓. The target lesions (irradiated lesions) are \> 5cm in in diameter
✓. ECOG 0-2.
Exclusion criteria
✕. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis and/or spinal cord compression, etc.
✕. With oncologic emergencies that require immediate treatment
✕. EGFR/ALK/ROS-1 mutation or mutation status unknown.
✕. Has evidence of interstitial lung disease or active and/or non-infectious pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring steroid therapy.
What they're measuring
1
Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and Tolerability of Low Dose Radiotherapy, Concurrent SBRT and PD-1 Inhibitors in Advanced NSCLC.
✕. History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway obstruction disease
✕. Patients with peripheral neuropathy.
✕. Significant heart disease or impairment of cardiac function
✕. Fluid accumulating in the third space, such as pericardial effusion, pleural effusion and peritoneal effusion that remains uncontrolled by aspiration or other treatment