An Exploratory Study of RGL-270 in Combination With PD-1/PD-L1 Inhibitors in Patients With Unresectable Locally Advanced or Recurrent/Metastatic Non-Small Cell Lung Cancer
Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a single-center, open-label, investigator-initiated clinical trial. It aims to evaluate the safety and tolerability of RGL-270 in combination with a PD-1/PD-L1 inhibitor, to assess immunogenicity, preliminary efficacy, and exploratory biomarkers and to observe the safety and effectiveness of PD-1/PD-L1 inhibitor monotherapy in advanced NSCLC subjects through a real-world observational cohort.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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Locations
Other Locations
China
Guangdong Provincial Perople's Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Wang Hao
hao.wang@regenelead.com
Backup
Xiaojun Tan
xiaojun.tan@regenelead.com
Time Frame
Start Date: 2025-10-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
Experimental: the study cohort
The purpose of the study arm is to evaluate the safety, tolerability, immunogenicity, and preliminary effectiveness of the RGL-270 in combination with a PD-1/PD-L1 inhibitor in subjects with advanced non-small cell lung cancer (NSCLC)
Other: the real-world observational cohort
Physician's Choice SOC as the parallel control
Related Therapeutic Areas
Sponsors
Leads: Guangdong Association of Clinical Trials
Collaborators: Shanghai Regenelead Theraples,Co,Ltd.