Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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

Eligibility criteria

Qualifiers

ECOG functional status score was 0-1.

Histologically confirmed stage IV primary NSCLC;

Genetic testing showed that the common driver genes including EGFR, ALK and ROS-1 were negative;

Patients with brain metastases were eligible if they were neurologically asymptomatic and had stable disease without receiving systemic glucocorticoids;

Disqualifiers

The patient had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.

Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;

Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;

History of other malignant tumors;

Trial design

Treatments tested in this trial

  • SBRT or LDRT
  • PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy

Treatment groups

146 Participants
are divided into 2 treatment groups

Sponsors and collaborators