RGL-270 + ICI in Advanced NSCLC

NCT07652125 | Recruiting

• 1 other identifier: CTONG2504/Ad-NSCLC-IIT-RGL-27
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC

Outcome Measures

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.

  through study completion, an average of 3 years.

Secondary Outcomes (2)

• Evaluate the immunogenicity of personalized tumor vaccine

  through study completion, an average of 3 years.

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

  through study completion, an average of 3 years.

Study Arms (2)

the study cohort

EXPERIMENTAL

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)

Biological: RGL-270 in Combination with PD-1/PD-L1 Inhibitors

the real-world observational cohort

OTHER

Physician's Choice SOC as the parallel control

Other: Physician's Choice SOC

Interventions

Physician's Choice SOC OTHER

a real-world observational cohort as the parallel control

the real-world observational cohort

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

Personalized neoantigen mRNA vaccines

the study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).
• Investigator-assessed contraindications for immunotherapy.
• Evidence of active tuberculosis within 1 year pre-screening, regardless of treatment.
• History of interstitial lung disease (ILD), suspected active ILD on screening CT, or idiopathic pulmonary fibrosis/organizing pneumonia (e.g., BOOP/cryptogenic OP).
• Severe active infection requiring IV antibiotics/antifungals/antivirals ≤28 days pre-screening or during screening.
• Clinically uncontrolled effusions requiring drainage ≤14 days pre-screening (pleural/peritoneal/pericardial).
• Hypersensitivity to study drug excipients or severe vaccine allergy history.
• Other malignancies within 5 years (exceptions: cured cervical CIS, basal/squamous skin cancer, localized prostate cancer post-radical therapy, DCIS, papillary thyroid cancer).
• Allogeneic organ or hematopoietic stem cell transplantation.
• Congenital/acquired immunodeficiency (e.g., DiGeorge syndrome, T-/B-cell deficiencies, Wiskott-Aldrich, ataxia-telangiectasia, CVID) or HIV infection.
• Active hepatitis B (defined as positive hepatitis B surface antigen \[HBsAg\] at screening AND HBV DNA ≥500 IU/mL or above the upper limit of normal \[ULN\] at the local institution), OR active hepatitis C (defined as positive hepatitis C antibody \[HCV-Ab\] at screening AND detectable HCV-RNA).
• Uncontrolled or significant cardiovascular disease, including:

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead
• Shanghai Regenelead Theraples,Co,Ltd.: collaborator

Study Sites (1)

Guangdong Provincial Perople's Hospital

Guangzhou, Other (Non U.s.), 510080, China

RECRUITING

Central Study Contacts

Wang Hao

CONTACT

hao.wang@regenelead.com

Xiaojun Tan

CONTACT

xiaojun.tan@regenelead.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-arm, open-label trial with approximately 20 subjects each in the study cohort and the real-world observational cohort.

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: June 16, 2026
• Study Start: October 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

CN (1)