At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed stage IV primary NSCLC
- ✓Negative for common driver genes EGFR, ALK, and ROS1
- ✓Life expectancy at least 3 months
- ✓Able to understand and voluntarily sign informed consent
- ✕Severe autoimmune diseases including inflammatory bowel disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis
- ✕Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia
- ✕Risk factors for intestinal perforation including active diverticulitis, intra-abdominal abscess, GI obstruction, abdominal cancer
- ✕History of other malignant tumors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06313541Phase 2RecruitingUpdate OverdueUpdated 24mo ago · Completion was 12mo agoA Multicenter, Randomized Controlled Clinical Trial of Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy
In Brief
A Phase 2 clinical trial evaluating SBRT or LDRT and PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy for NSCLC Stage IV. Currently recruiting, targeting 146 participants across 1 site.
Signals
Detailed Summary
This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC
Study Details
Timeline
Interventions
Radiotherapy: (1) Low dose radiotherapy (LDRT) : a dose of 2 Gy/1 Fx was given to all visible lesions in the whole body within 1 week before the first course of PD-1/PD-L1 inhibitor combined with chemotherapy (different parts of the lesion could be irradiated separately, but it was required to be completed within 1 week); (2) SBRT: patients received first-line immunotherapy combined with chemotherapy, and their response was evaluated every 6 weeks. Individualized SBRT was planned based on the treatment responses.
The control group received standard PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy as first-line treatment, and the experimental group received extra treatment response adapted hybrid radiotherapy.