NSCLCPhase 2NCT07379398
Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer
A Phase 2 study testing lparomlimab and Tuvonralimab Injection in Combination with SBRT in people with NSCLC, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Major objectives to evaluate the efficacy and safety of lparomlimab and Tuvonralimab Injection ((QL1706, an Anti-PD-1/CTLA-4 Combined Antibody)) combined with SBRT in patients with early-stage non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- lparomlimab and Tuvonralimab Injection in Combination with SBRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Jan 2031
- Phase
- Phase 2
- 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
- Understand and voluntarily sign the informed consent form for this study;
- Age ≥ 18 years;
- ECOG performance status of 0-1;
- Histologically confirmed non-small cell lung cancer, meeting AJCC 8th edition Stage IA-IB (tumor size ≤ 4cm, N0M0), Stage IIA (≤5cm, N0M0), or Stage IIB (>5cm and ≤7cm, N0M0);
- At least one repeatable measurable lesion at baseline (according to RECIST 1.1 criteria);
- Function of vital organs within 7 days prior to initial treatment meets the following requirements (use of any blood components or colony-stimulating factors within 14 days prior to enrollment is not allowed): Hemoglobin (Hb) ≥ 90 g/L; White Blood Cell (WBC) count ≥ 3.5 × 10^9/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L; Platelets (PLT) ≥ 80 × 10^9/L; Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN); if liver metastases are present, AST and ALT ≤ 5 × ULN; Total Bilirubin (TBIL) ≤ 1.5 × ULN; Blood Urea Nitrogen (BUN) and Creatinine (Cr) ≤ 1.5 × ULN (and Creatinine Clearance (CCr) ≥ 50 mL/min); Left Ventricular Ejection Fraction (LVEF) ≥ 50%; QT interval corrected by Fridericia's formula (QTcF) < 470 milliseconds;
- Eligible patients of childbearing potential must agree to use a reliable method of contraception together with their partner during the trial period and for at least 180 days after the last dose of the study drug.
Who cannot join
- Inability to comply with the research protocol or study procedures.
- Previous receipt of any treatment, including chemotherapy or radiotherapy, for the currently diagnosed lung cancer.
- Patients with positive driver gene mutations such as EGFR, ALK, or ROS1.
- History of allergy or hypersensitivity to the investigational drug(s) or any of their excipients, or a history of atopy.
- Presence of active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other diseases, symptoms, or signs indicating severe pulmonary impairment during the screening period.
- Concurrent severe cardiovascular or cerebrovascular diseases.
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- Receipt of broad-spectrum antibiotic therapy via any route within 30 days prior to the first dose.
- Positive anti-HIV test; positive Hepatitis B surface antigen (HBsAg) with HBV-DNA above the upper limit of normal (ULN); active Hepatitis C virus (HCV) infection.
- Evident bleeding tendency or other significant evidence of coagulation disorders.
- Current interstitial pneumonia or interstitial lung disease, or a prior history of interstitial pneumonia or interstitial lung disease requiring corticosteroid treatment; or other conditions such as pulmonary fibrosis or organizing pneumonia that may interfere with the assessment and management of immune-related pulmonary toxicity.
- Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage (except for cases with only minimal ascites visible on imaging without clinical symptoms), or uncontrolled or moderate-to-large pleural effusion or pericardial effusion.
- Ongoing systemic corticosteroid therapy or other immunosuppressive agents within 14 days prior to the first dose, or use of immunostimulants (including but not limited to interferon or interleukin-2) within 4 weeks prior.
- Diagnosis of other malignancies within 5 years prior to enrollment, except for radically resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix.
- Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment.
- Patients deemed by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
About this study
Official title: A Single-center, Single-arm Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer
Major objectives to evaluate the efficacy and safety of lparomlimab and Tuvonralimab Injection ((QL1706, an Anti-PD-1/CTLA-4 Combined Antibody)) combined with SBRT in patients with early-stage non-small cell lung cancer.
Read the detailed description
This single-arm, single-center clinical study aims to evaluate the efficacy and safety of lparomlimab and Tuvonralimab Injection ((QL1706, an Anti-PD-1/CTLA-4 Combined Antibody)) combined with SBRT in patients with early-stage non-small cell lung cancer. This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.
- Conditions
- NSCLC
- Being tested
- lparomlimab and Tuvonralimab Injection in Combination with SBRT
- Keywords
- lparomlimab and Tuvonralimab Injection, SBRT, early-stage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lparomlimab and Tuvonralimab Injection in Combination with SBRTDrug
lparomlimab and Tuvonralimab Injection: 5 mg/kg, administered every 3 weeks (q3w). The first dose should be given within one week after the initial SBRT fraction. The treatment duration is one year.
SBRT: 50 Gy in 4 fractions or 70 Gy in 10 fractions, to be completed within 1-2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with SBRT | Experimental | lparomlimab and Tuvonralimab Injection in Combination with SBRT Receives: Drug: lparomlimab and Tuvonralimab Injection in Combination with SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year EFS
Measured: up to 12 month
Secondary outcomes (3)
Objective response rate
the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment.
Measured: up to 12 month
Overall survival
OS was defined as the time from the first dose of study drug to death due to any cause.
Measured: up to 36 month
Adverse Events
An AE was defined as any untoward medical occurrence in a pharmaceutical productwhich does not necessarily have to have a causal relationship with this treatment.
Measured: up to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Jan 2031 (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.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiyong Yuan, Principal investigator, Tianjin Medical University Cancer Institute and HospitalNingbo Liu, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379398
- Sponsor's protocol ID
- E20251143A
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07379398
- Acronym / sponsor ID
- E20251143A
- Conditions
- NSCLC
- Keywords
- lparomlimab and Tuvonralimab Injection, SBRT, early-stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 30 Jan 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.
Major objectives to evaluate the efficacy and safety of lparomlimab and Tuvonralimab Injection ((QL1706, an Anti-PD-1/CTLA-4 Combined Antibody)) combined with SBRT in patients with early-stage non-small cell lung cancer.
Detailed description
This single-arm, single-center clinical study aims to evaluate the efficacy and safety of lparomlimab and Tuvonralimab Injection ((QL1706, an Anti-PD-1/CTLA-4 Combined Antibody)) combined with SBRT in patients with early-stage non-small cell lung cancer. This study consists of three phases: screening, treatment, and follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with SBRT | Experimental | Drug: lparomlimab and Tuvonralimab Injection in Combination with SBRTlparomlimab and Tuvonralimab Injection in Combination with SBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Understand and voluntarily sign the informed consent form for this study;
- Age ≥ 18 years;
- ECOG performance status of 0-1;
- Histologically confirmed non-small cell lung cancer, meeting AJCC 8th edition Stage IA-IB (tumor size ≤ 4cm, N0M0), Stage IIA (≤5cm, N0M0), or Stage IIB (>5cm and ≤7cm, N0M0);
- At least one repeatable measurable lesion at baseline (according to RECIST 1.1 criteria);
Key exclusion criteria (15 listed)
- Inability to comply with the research protocol or study procedures.
- Previous receipt of any treatment, including chemotherapy or radiotherapy, for the currently diagnosed lung cancer.
- Patients with positive driver gene mutations such as EGFR, ALK, or ROS1.
- History of allergy or hypersensitivity to the investigational drug(s) or any of their excipients, or a history of atopy.
- Presence of active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other diseases, symptoms, or signs indicating severe pulmonary impairment during the screening period.
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 |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with SBRTlparomlimab and Tuvonralimab Injection: 5 mg/kg, administered every 3 weeks (q3w). The first dose should be given within one week after the initial SBRT fraction. The treatment duration is one year. SBRT: 50 Gy in 4 fractions or 70 Gy in 10 fractions, to be completed within 1-2 weeks. | Drug | lparomlimab and Tuvonralimab Injection in Combination with SBRT |
Primary outcome
1-year EFS
Time frame: up to 12 month
3 secondary outcomes
Objective response rate
Time frame: up to 12 month
Overall survival
Time frame: up to 36 month
Adverse Events
Time frame: up to 36 month
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 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Zhiyong Yuan principal investigator
Tianjin Medical University Cancer Institute and Hospital
Ningbo Liu principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lparomlimab and Tuvonralimab Injection in Combination with SBRT in people with NSCLC, run by Tianjin Medical University Cancer Institute and Hospital 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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 29 Apr 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ningbo Liu (15822117210, liuningbo@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year EFS (time frame: up to 12 month). 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 29 Apr 2026.