Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer

NCT07379398 | Not Yet Recruiting Phase 2

• 1 other identifier: E20251143A
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC

Keywords

lparomlimab and Tuvonralimab Injection; SBRT; early-stage

Outcome Measures

Primary Outcomes (1)

• 1-year EFS

  up to 12 month

Secondary Outcomes (3)

• Objective response rate

  up to 12 month

• Overall survival

  up to 36 month

• Adverse Events

  up to 36 month

Study Arms (1)

lparomlimab and Tuvonralimab Injection in Combination with SBRT

EXPERIMENTAL

lparomlimab and Tuvonralimab Injection in Combination with SBRT

Drug: lparomlimab and Tuvonralimab Injection in Combination with SBRT

Interventions

lparomlimab and Tuvonralimab Injection in Combination with SBRT DRUG

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.

lparomlimab and Tuvonralimab Injection in Combination with SBRT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Zhiyong Yuan

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Ningbo Liu

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ningbo Liu

CONTACT

15822117210; liuningbo@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): January 31, 2031
• Last Updated: April 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)