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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • RGL-270 in Combination with PD-1/PD-L1 Inhibitors

    Biological/Vaccine

    Personalized neoantigen mRNA vaccines

  • Physician's Choice SOC

    Other intervention

    a real-world observational cohort as the parallel control

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: the study cohortExperimental treatment 1 intervention
Group B: the real-world observational cohortOther 1 intervention

Trial outcomes

Primary outcomes

1

Safety Endpoints

To evaluate the safety and tolerability of personalized tumor vaccine in combination with PD-1/PD-L1 inhibitors in patients with advanced NSCLC.

Time frame
through study completion, an average of 3 years.

Secondary outcomes

1

Evaluate the immunogenicity of personalized tumor vaccine

Time frame
through study completion, an average of 3 years.
2

To evaluate the preliminary efficacy of personalized tumor vaccine combined with PD-1/PD-L1 inhibitors in patients with advanced NSCLC

Time frame
through study completion, an average of 3 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Association of Clinical Trials

Lead sponsor

Shanghai Regenelead Theraples,Co,Ltd.

Collaborator

Source ClinicalTrials.gov
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