The IVO-LUNG Study

NCT07204548 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-FXY-236
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II, open-label, single-arm study evaluates the efficacy and safety of one-year Ivonescimab consolidation therapy in patients with unresectable Stage III NSCLC who have not progressed after definitive chemoradiotherapy.

Conditions

Non Small Cell Lung Cancer (Stage III)

Outcome Measures

Primary Outcomes (1)

• 12-month PFS rate

  The percentage of patients who has not experienced first documented progression or date of death from any cause, whichever came first, assessed up to 12 months from the date of enrollment.

  From the date of enrollment untill 12 month

Secondary Outcomes (4)

• Objective Response Rate(ORR)

  From the date of enrollment untill the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months"

• Progression free survival

  From the date of enrollment to the date of first documented progression or date of death from any cause, assessed up to 100 months.

• overall survival

  From enrollment to death

• Treatment related adverse event

  From enrollment to discontinuation of the study

Study Arms (1)

Ivonescimab as consolidation after definitive concurrent/sequential chemoradiotherapy

EXPERIMENTAL

Ivonescimab as consolidation after definitive concurrent/sequential chemoradiotherapy. Ivonescimab is given by 20mg/kg BW,q3w, last for one year.

Drug: Ivonescimab

Interventions

Ivonescimab DRUG

Ivonescimab is given after definitive concurrent/sequential chemoradiotherapy

Also known as: AK112, AK-112

Ivonescimab as consolidation after definitive concurrent/sequential chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide voluntary written informed consent.
• age: 18-75 years old
• ECOG performance status: 0 or 1
• With a life expectancy of ≥ 3 months.
• Patients with radiologically confirmed, treatment-naïve, unresectable Stage III NSCLC (staged according to the American Joint Committee on Cancer, 8th edition) who did not progress after definitive concurrent/sequential chemoradiotherapy. Induction therapy prior to chemoradiotherapy was permitted.
• Negative for EGFR L858R/19del, ALK fusion, ROS1 fusion, RET fusion, BRAF V600E mutation, NTRK fusion, and MET exon 14 skipping mutation.
• Presence of at least one measurable lesion per RECIST v1.1, which is suitable for accurate and reproducible repeated measurements.
• For the exploration of efficacy-related biomarkers, the submission of tumor tissue, peripheral blood, and stool samples is required. Patients with biologically unavailable samples may be granted an exemption from this requirement.
• Adequate organ function based on examinations within 14 days prior to the initiation of study treatment.
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test must be performed, and the serum result shall be considered definitive). If a female subject of childbearing potential engages in sexual activity with a non-sterilized male partner, the subject must use a highly effective method of contraception starting from screening and must agree to continue its use for 120 days after the last dose of the study drug; the decision to discontinue contraception after this time point should be discussed with the investigator.
• Non-sterilized male subjects who engage in sexual activity with a female partner of childbearing potential must use a highly effective method of contraception from the start of screening until 120 days after the last dose; the decision to discontinue contraception after this time point should be discussed with the investigator.
• The subject is willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and other study requirements.

You may not qualify if:

• Patients with non-small cell lung cancer (NSCLC) that contains a small cell carcinoma component.
• History of other malignancies (except carcinoma in situ of the cervix, non-melanoma skin cancer, bladder carcinoma in situ, etc.) or presence of other life-threatening diseases that may affect the completion of the study.
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study.
• Imaging during the screening period shows tumor invasion or the presence of significant necrosis or cavitation, and the investigator judges that study entry would pose a bleeding risk.
• History of severe bleeding tendency or coagulation dysfunction; presence of clinically significant bleeding symptoms within 1 month prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or spitting up ≥1 teaspoon of fresh blood or small blood clots, or coughing up blood without sputum; subjects with blood-tinged sputum are allowed), epistaxis (excluding minor nosebleeds and blood-tinged postnasal drip); received continuous antiplatelet or anticoagulant therapy within 10 days prior to the first dose.
• Tumor compression of surrounding vital organs (e.g., esophagus) accompanied by related symptoms, compression of the superior vena cava, or invasion of mediastinal great vessels, heart, etc.
• Received non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for treating thrombocytopenia) within 2 weeks prior to the first dose; received Chinese herbal medicine or Chinese proprietary medicine with anti-tumor indications within 2 weeks prior to the first dose.
• Previously received surgical resection and experienced postoperative recurrence of Stage III NSCLC.
• History of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy, or current non-infectious pneumonitis.
• Presence of uncontrolled serous cavity effusion.
• Presence of uncontrolled comorbid diseases, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements or impair the ability to provide written informed consent.
• History of myocarditis, cardiomyopathy, or malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or above), or vascular disease (e.g., aortic aneurysm at risk of rupture) requiring hospitalization within 12 months prior to the first dose, or other cardiac damage that may affect the evaluation of study drug safety (e.g., poorly controlled arrhythmia, myocardial ischemia); History of esophageal/gastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose; Any arterial thromboembolic event, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first dose; Acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to the first dose; Current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive medication.
• Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; Active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C).
• Active or history of definite autoimmune diseases, including but not limited to inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea), systemic lupus erythematosus, or other conditions unsuitable for treatment with immune checkpoint inhibitors.
• History of immunodeficiency; Positive HIV antibody test; Current long-term use of systemic corticosteroids or other immunosuppressants.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Li-Kun Chen

Guangzhou, Guangzhou, 510006, China

Location

Related Publications (1)

• Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

  PMID: 28885881 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Likun Chen, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Likun Chen

CONTACT

020-87343410; chenlk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)