NSCLCNCT07652125
RGL-270 + ICI in Advanced NSCLC
A study testing RGL-270 in Combination with PD-1/PD-L1 Inhibitors and Physician's Choice SOC in people with NSCLC, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- RGL-270 in Combination with PD-1/PD-L1 Inhibitors and Physician's Choice SOC
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
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- 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:
- Symptomatic congestive heart failure (NYHA Class III or IV) Myocardial infarction within 6 months prior to screening Unstable angina within 1 month prior to screening Clinically significant arrhythmias requiring therapeutic intervention Refractory hypertension despite adequate treatment (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg)
- 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 unacceptable safety risks Insufficient neoantigen burden for vaccine production (based on tumor sequencing analysis) Vaccine manufacturing failure
- Subjects 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 assesses that medication can continue, they are allowed to continue participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wang Hao contact
Xiaojun Tan contact
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Perople's Hospital
Guangzhou, Other (Non U.s.), 510080
Qing Zhou, 02083827812, gzzhouqing@126.com
About this study
Official title: 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
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
- Being tested
- RGL-270 in Combination with PD-1/PD-L1 Inhibitors, Physician's Choice SOC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGL-270 in Combination with PD-1/PD-L1 InhibitorsBiological
Personalized neoantigen mRNA vaccines
Physician's Choice SOCOther
a real-world observational cohort as the parallel control
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Physician's Choice SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 3 years.
Secondary outcomes (2)
Evaluate the immunogenicity of personalized tumor vaccine
Measured: 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
Measured: through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start25 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-arm, open-label trial with approximately 20 subjects each in the study cohort and the real-world observational cohort.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Regenelead Theraples,Co,Ltd.
- Responsible party
- Principal investigator, Zhou Qing, Guangdong Association of Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652125
- Sponsor's protocol ID
- CTONG2504/Ad-NSCLC-IIT-RGL-27
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07652125
- Acronym / sponsor ID
- CTONG2504/Ad-NSCLC-IIT-RGL-27
- Conditions
- NSCLC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Collaborators
- Shanghai Regenelead Theraples,Co,Ltd.
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-arm, open-label trial with approximately 20 subjects each in the study cohort and the real-world observational cohort.
| Arm | Type | Receives |
|---|---|---|
| the study cohort | Experimental | Biological: RGL-270 in Combination with PD-1/PD-L1 InhibitorsThe 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) |
| the real-world observational cohort | Other | Other: Physician's Choice SOCPhysician's Choice SOC as the parallel control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGL-270 in Combination with PD-1/PD-L1 InhibitorsPersonalized neoantigen mRNA vaccines | Biological | the study cohort |
| Physician's Choice SOCa real-world observational cohort as the parallel control | Other | the real-world observational cohort |
Primary outcome
Safety Endpoints
Time frame: through study completion, an average of 3 years.
To evaluate the safety and tolerability of personalized tumor vaccine in combination with PD-1/PD-L1 inhibitors in patients with advanced NSCLC.
2 secondary outcomes
Evaluate the immunogenicity of personalized tumor vaccine
Time frame: 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
Time frame: through study completion, an average of 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wang Hao contact
Xiaojun Tan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RGL-270 in Combination with PD-1/PD-L1 Inhibitors and Physician's Choice SOC in people with NSCLC, run by Guangdong Association of Clinical Trials at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Hao (hao.wang@regenelead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoints (time frame: through study completion, an average of 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.