Non Small Cell Lung Cancer (Stage III)Phase 2IVO LungNCT07204548
The IVO-LUNG Study
A Phase 2 study testing Ivonescimab in people with Non Small Cell Lung Cancer (Stage III), run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer (Stage III)
- What is being tested?
- Ivonescimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- Oct 2025to Oct 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Known active tuberculosis (TB); subjects suspected of having active TB require clinical evaluation to rule it out (e.g., sputum TB test, chest X-ray, etc.); Known active syphilis infection.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Subjects with active hepatitis B (HBsAg positive and HBV-DNA >1000 copies/ml or above the lower limit of detection); Subjects with active hepatitis C (HCV-RNA positive).
- Major surgery or severe trauma within 30 days prior to the first dose, or planned major surgery within 30 days after the first dose (as determined by the investigator); Minor local surgery within 3 days prior to the first dose (excluding PICC line placement, port implantation).
- Received live attenuated vaccines within 30 days prior to the first dose, or plans to receive live attenuated vaccines during the study period; Note: Live attenuated influenza vaccines cannot be administered within 90 days after the last dose of study treatment.
- Known allergy to any component of the study drug; History of severe hypersensitivity reactions to other monoclonal antibodies.
- Known history of mental illness, drug abuse, alcoholism, or substance abuse.
- Pregnant or lactating women.
- Any disease, treatment, or laboratory abnormality, historical or current, that may confound the study results, interfere with the subject's full participation in the study, or for which participation may not be in the best interest of the subject.
- Uncontrolled metabolic disorders; or local or systemic diseases not caused by malignancy; or secondary diseases or symptoms caused by the tumor that could pose a high medical risk and/or uncertainty in survival evaluation, such as tumor-related leukemoid reaction (white blood cell count >20×10⁹/L), cachexia (e.g., known weight loss >10% in the 3 months prior to screening), etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ivonescimab Consolidation After Concurrent/Sequential Chemoradiation for Unresectable Stage III NSCLC- A Phase II Study
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.
Read the detailed description
This is an open-label, single-arm, Phase II clinical study. The study plans to enroll previously untreated patients with Stage III (AJCC 8th edition) unresectable NSCLC who have not progressed after definitive concurrent/sequential chemoradiotherapy (≥2 cycles of platinum-based doublet chemotherapy). Induction therapy prior to concurrent or sequential chemoradiation is permitted. Subjects will receive Ivonescimab consolidation therapy for one year. The study aims to evaluate the efficacy and safety of Ivonescimab as consolidation therapy, alongside the exploration of efficacy-related biomarkers.
- Conditions
- Non Small Cell Lung Cancer (Stage III)
- Being tested
- Ivonescimab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvonescimabDrug
Also called AK112, AK-112
Ivonescimab is given after definitive concurrent/sequential chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ivonescimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of enrollment untill 12 month
Secondary outcomes (4)
Objective Response Rate(ORR)
(Number of patients with CR + Number of patients with PR) / Total number of evaluable patients based on the RECIST V1.1
Measured: 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 date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Measured: 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
Survival time from enrollment to death
Measured: From enrollment to death
Treatment related adverse event
Any unfavorable and unintended sign, symptom, or disease that occurs in a participant during a clinical trial, which is deemed to have a reasonable possibility of being caused by the study treatment.
Measured: From enrollment to discontinuation of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung Cancer (Stage III)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-kun Chen, Sun Yat-sen University
- Investigators
- Likun Chen, Doctor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204548
- Sponsor's protocol ID
- 2025-FXY-236
- Acronym
- IVO Lung
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28885881
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivonescimab Consolidation After Concurrent/Sequential Chemoradiation for Unresectable Stage III NSCLC- A Phase II Study
- ClinicalTrials.gov ID
- NCT07204548
- Acronym / sponsor ID
- IVO Lung / 2025-FXY-236
- Conditions
- Non Small Cell Lung Cancer (Stage III)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 2 Oct 2025 (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 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.
Detailed description
This is an open-label, single-arm, Phase II clinical study. The study plans to enroll previously untreated patients with Stage III (AJCC 8th edition) unresectable NSCLC who have not progressed after definitive concurrent/sequential chemoradiotherapy (≥2 cycles of platinum-based doublet chemotherapy). Induction therapy prior to concurrent or sequential chemoradiation is permitted. Subjects will receive Ivonescimab consolidation therapy for one year. The study aims to evaluate the efficacy and safety of Ivonescimab as consolidation therapy, alongside the exploration of efficacy-related biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab as consolidation after definitive concurrent/sequential chemoradiotherapy | Experimental | Drug: IvonescimabIvonescimab as consolidation after definitive concurrent/sequential chemoradiotherapy. Ivonescimab is given by 20mg/kg BW,q3w, last for one year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| IvonescimabAlso: AK112, AK-112Ivonescimab is given after definitive concurrent/sequential chemoradiotherapy | Drug | Ivonescimab as consolidation after definitive concurrent/sequential chemoradiotherapy |
Primary outcome
12-month PFS rate
Time frame: From the date of enrollment untill 12 month
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.
4 secondary outcomes
Objective Response Rate(ORR)
Time frame: 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
Time frame: 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
Time frame: From enrollment to death
Treatment related adverse event
Time frame: From enrollment to discontinuation of the study
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 2 Oct 2025.
- Background: PubMed 28885881Antonia 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.
- 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.
Likun Chen, Doctor principal investigator
Sun Yat-Sen University Cancer Center
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 Ivonescimab in people with Non Small Cell Lung Cancer (Stage III), run by Sun Yat-sen University 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 12 inclusion and 25 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 2 Oct 2025. 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 Prof. Likun Chen (020-87343410, chenlk@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month PFS rate (time frame: From the date of enrollment untill 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07204548, which also lists 1 linked publication.
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 2 Oct 2025.