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New treatment option for NSCLC
Official title RGL-270 + ICI in Advanced NSCLC
ClinicalTrials.gov ID: NCT07652125
What this study is testing
What is RGL-270 in Combination with PD-1/PD-L1 Inhibitors?
RGL-270 in Combination with PD-1/PD-L1 Inhibitors is an investigational medicine, being studied as a potential treatment for nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people capable of understanding/compliance with study procedures and voluntarily signing informed consent.
- Age ≥18, any gender.
- Histologically/cytologically confirmed NSCLC. 5.ECOG performance status 0 or 1. 6.Life expectancy ≥6 months. 7\. Subject must have at least one...
You likely can't join if
- Histologically/cytologically confirmed small cell lung cancer (SCLC), mixed tumors with SCLC components, neuroendocrine tumors with large cell...
- Actionable driver mutations (e.g., EGFR/ALK) where targeted therapy is accessible per investigator assessment, except for patients refusing targeted...
- Prior radiotherapy within 5 years or history of immunotherapy/cancer vaccines (including but not limited to TILs, CAR-T, TCR-T, therapeutic cancer...
- Live vaccines administered ≤28 days pre-screening or planned during study/within 90 days post-treatment (inactivated vaccines permitted).
- Investigator-assessed contraindications for immunotherapy.
- Active autoimmune diseases (exclusion: hypothyroidism from autoimmune thyroiditis requiring hormone replacement only).
See the full eligibility criteria
- people capable of understanding/compliance with study procedures and voluntarily signing informed consent.
- Age ≥18, any gender.
- Histologically/cytologically confirmed NSCLC. 5.ECOG performance status 0 or 1. 6.Life expectancy ≥6 months. 7\. Subject must have at least one measurable tumor lesion by RECIST 1.1 criteria at baseline prior to...
- 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.
- Active autoimmune diseases (exclusion: hypothyroidism from autoimmune thyroiditis requiring hormone replacement only).
- 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...
- Uncontrolled or significant cardiovascular disease, including: Symptomatic congestive heart failure (NYHA Class III or IV) Myocardial infarction within 6 months prior to screening Unstable angina within 1 month prior to...
- Any other condition deemed by the investigator to potentially compromise trial conduct or outcome interpretation, including but not limited to: Anticipated poor compliance with study procedures Comorbidities posing...
- people who experienced severe irAE during the run-in treatment period resulting in permanent discontinuation of PD-1/PD-L1 inhibitors.
- If a subject experiences comprehensive disease progression during the introduction treatment but only has clinical deterioration, or if the intracranial lesion stabilizes after local treatment and the investigator...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Other (Non U.s.), China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Other (Non U.s.), China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.