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Iparomlimab and Tuvonralimab Injection Combined With SBRT in Patients With Early-Stage Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

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

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

NCT07379398•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.
+5 more criteria

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

April 1, 2026

Primary Completion Date

June 30, 2029

Completion Date

January 31, 2031

Last Updated

January 30, 2026

Enrollment

ESTIMATED participants

Conditions

NSCLC

Interventions

lparomlimab and Tuvonralimab Injection in Combination with SBRT

DRUG

Contacts

Ningbo Liu

CONTACT

15822117210 liuningbo@tjmuch.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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