RGL-270 + ICI in Advanced NSCLC
ConditionNSCLC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Association of Clinical Trials
About this trial
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 criteria
Qualifiers
Subjects capable of understanding/compliance with study procedures and voluntarily signing informed consent.
Age ≥18, any gender.
Histologically/cytologically confirmed NSCLC.
Disqualifiers
Histologically/cytologically confirmed small cell lung cancer (SCLC), mixed tumors with SCLC components, neuroendocrine tumors with large cell components, or sarcomatoid carcinoma.
Actionable driver mutations (e.g., EGFR/ALK) where targeted therapy is accessible per investigator assessment, except for patients refusing targeted treatment.
Prior radiotherapy within 5 years or history of immunotherapy/cancer vaccines (including but not limited to TILs, CAR-T, TCR-T, therapeutic cancer vaccines).
Live vaccines administered ≤28 days pre-screening or planned during study/within 90 days post-treatment (inactivated vaccines permitted).
Trial design
Treatments tested in this trial
- RGL-270 in Combination with PD-1/PD-L1 Inhibitors
- Physician's Choice SOC
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
1Guangdong Provincial Perople's Hospital510080, GuangzhouOther (Non U.s.), China
Sponsors and collaborators
Guangdong Association of Clinical Trials
Lead sponsor
Shanghai Regenelead Theraples,Co,Ltd.
Collaborator
Source ClinicalTrials.gov