ClinicalTrials.gg
Not yet recruitingNCT07936578Updated Nov 13, 2026

Clinical Study of Ivonescimab Combined With Concurrent Chemoradiotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

A Phase 2 interventional study of Ivonescimab plus chemotherapy followed by 2-year ivonescimab maintenance after concurrent chemoradiotherapy in stage IV non-small cell lung cancer in Concurrent Chemoradiotherapy, Immunotherapy and Lung Cancer (NSCLC), sponsored by Guizhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

Primary conditionCarcinoma, Non-Small-Cell LungRegistry: Lung NeoplasmsReclassifiedWhy we changed it
Registry
Lung Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Carcinoma, Non-Small-Cell Lung
Why
  1. The study's title name Carcinoma, Non-Small-Cell Lung, a narrower term within Lung Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Guizhou Medical University · Phase 2, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China — 763 open to participants now, 986 under way, 203 of them phase 3. Carcinoma, Non-Small-Cell Lung · China.

Planned enrollment
1,192nd of 1,592
40 · median 100
Started
2026
with 188 others
Phase 2
650 of 1,878
273 open now
Primary completion
2028-10
later than 807 of 985 live
Registered
1,878th of 1,878
by date

Among the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China, this one is the 1,192nd largest by planned enrollment of the 1,592 interventional ones that give a count, is one of 189 that started in 2026, is one of 650 in phase 2, reaches primary completion later than 807 of the 985 other live ones, and was the 1,878th registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

763 of the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China are open now. Recruiting first, the newest first:

758 more — sign in →

All 763 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China, or all of them as a file.
02

Study summary

This prospective, exploratory study will evaluate the objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and toxicity of ivonescimab plus chemotherapy for 2-4 cycles after concurrent chemoradiotherapy, followed by 2 years of ivonescimab maintenance therapy, in patients with stage IV non-small cell lung cancer (NSCLC). The findings will be compared with those of previous studies and with our institutional data on patients with stage IV NSCLC who received concurrent chemoradiotherapy followed by PD-1 inhibitor plus chemotherapy for 2-4 cycles and then 2 years of PD-1 inhibitor maintenance therapy. This comparison may demonstrate that, after concurrent chemoradiotherapy for stage IV NSCLC, ivonescimab plus chemotherapy for 2-4 cycles followed by 2 years of ivonescimab maintenance therapy achieves superior efficacy compared with PD-1 inhibitor plus chemotherapy for 2-4 cycles followed by 2 years of PD-1 inhibitor maintenance therapy, with a comparable toxicity profile.

03

Conditions studied

  • Concurrent Chemoradiotherapy
  • Immunotherapy
  • Lung Cancer (NSCLC)

Browse trials for

04

In context

Carcinoma, Non-Small-Cell Lung Reclassified

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

This study's planned enrollment of 40 is below the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Guizhou Medical University is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Compared within Carcinoma, Non-Small-Cell Lung, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have fully understood this study and voluntarily signed the Form (ICF)
  • Aged 18 to 75 years, regardless of gender
  • Previously untreated, histopathologically or confirmed unresectable TPS ≥ 1% Stage IV non-small cell lung cancer
  • Have according to version 1.1
  • Have adequate pulmonary function tests (PFTs)
  • Subjects must be able to provide a prior driver gene report based on tissue or blood testing, and the test results must show that targetable driver genes such as EGFR sensitive mutations, ALK rearrangement or fusion, and ROS1 fusion are all negative; or if a certain type of driver gene is positive but the targeted drug is not available, the subject may be enrolled. If the subject does not have a driver gene test report, tumor samples (archived or fresh, primary or ) or blood samples must be collected before enrollment for driver gene testing to confirm negativity (at a local laboratory or central laboratory)
  • performance status score of 0-1
  • Adequate organ and bone marrow function

    ① Hematology: (ANC) ≥ 1500/μL; ≥ 100,000/μL; ≥ 9.0 g/dL or ≥ 5.6 mmol/L.

    ② Renal: Serum creatinine ≤ 1.5 × or calculated (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).

    ③ Hepar: Total ≤ 1.5 × ULN, or for subjects with total bilirubin levels > 1.5 × ULN, direct bilirubin within normal limits; (SGOT) and ALT (SGPT) ≤ 2.5 × ULN.

    ④ Adequate coagulation function: (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Known (LVEF) ≥ 50%; Urine protein \< 1+ or if urine protein is 1+, further 24-hour urine protein quantification \< 1.0 g.

  • Endocrine System: Thyroid-stimulating hormone (TSH) within normal limits. Note: If TSH is not within the normal range at baseline, the subject may still meet the inclusion criteria if T3 and free T4 are within the normal range;Coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN, except for subjects receiving anticoagulant therapy, as long as PT or aPTT is within the intended therapeutic range of the anticoagulant drug.
  • Willing and able to comply with the study plan's visits, treatment plans, laboratory tests, and other study procedures.
  • Childbearing age women must have a serum pregnancy test within 3 days before the first dose, and the result must be negative. Female subjects of childbearing age and male subjects with partners of childbearing age must agree to use highly effective methods of during the study and for 180 days after the last dose of the study drug.

Exclusion criteria

Exclusion Criteria:

  • Presence of resectable or disease
  • History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring therapy, or currently receiving drug treatment or other clinical interventions, or presence of active pulmonary interstitial lesions or imaging findings of interstitial lung disease.
  • Known history of active tuberculosis
  • Known active infection requiring systemic therapy
  • Any known or suspected disease or immunodeficiency, except for: patients with a history of hypothyroidism who do not require hormone therapy or are receiving physiological doses of hormone replacement therapy; patients with stable blood glucose-controlled type 1 diabetes.
  • Uncontrolled active (defined as positive hepatitis B surface antigen [HBsAg] test at screening with HBV-DNA levels above the of the study center's laboratory; patients with HBV-DNA \<500 IU/mL within 28 days before enrollment who have received at least 14 days of standard local antiviral therapy and are willing to continue antiviral therapy during the study may be enrolled); active (defined as positive hepatitis C virus surface antibody [HCsAb] test at screening with positive HCV-RNA).
  • Known (HIV) infection (known HIV antibody positive)
  • Vaccination with within 30 days before the first dose, including but not limited to: mumps, rubella, measles, varicella/zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccine (inactivated virus vaccines are allowed).
  • History of severe allergic reactions to other monoclonal antibodies;
  • Known severe or uncontrolled underlying diseases
  • Patients with a history of another within 5 years before the first dose, other than non-small cell lung cancer, are excluded. This exclusion does not apply to malignancies with a negligible risk of metastasis or death (e.g., expected disease-free survival >5 years) that are expected to achieve a curative outcome after treatment (e.g., adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, or ductal carcinoma in situ treated with curative-intent surgery).
  • Class III-IV congestive heart failure ( classification), poorly controlled and arrhythmias.
  • Any arterial thrombosis, embolism, or ischemia within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or .
  • Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Investigators consider other conditions that may make the patient unsuitable for participation in this clinical trial.
Terms in these criteria, in plain language(27)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

06

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    ivonescimab combined with chemotherapy for 2-4 cycles followed by ivonescimab maintenance therapy

    Drug: Ivonescimab plus chemotherapy followed by 2-year ivonescimab maintenance after concurrent chemoradiotherapy in stage IV non-small cell lung cancer

Interventions

  • DrugIvonescimab plus chemotherapy followed by 2-year ivonescimab maintenance after concurrent chemoradiotherapy in stage IV non-small cell lung cancer

    After concurrent chemoradiotherapy, patients received 2-4 cycles of ivonescimab combined with chemotherapy, with each 3-week period defined as one dosing cycle. On Day 1 of each treatment cycle, ivonescimab was administered first by intravenous infusion; after an interval of at least 30 minutes, pemetrexed or paclitaxel/albumin-bound paclitaxel was administered intravenously. On Day 2, carboplatin or cisplatin was administered intravenously. Patients without disease progression received ivonescimab maintenance therapy for up to 2 years or until discontinuation due to toxicity-related intolerance.

07

What researchers measure

Primary outcomes

  1. Objective response rate

    Confirmed ORR assessed by investigators per RECIST 1.1, i.e., the proportion of subjects with CR+PR

    Time frame: From the first dose to week 24 (±7 days)

  2. Median progression-free survival

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

08

Study locations

1 site
  • the Affiliated Cancer Hospital of Guizhou Medical University
    Guiyang, Guizhou 550008, China
    • Weiwei Ouyang, MD · Contactouyangww103173@163.com · 18275356814
    • Dongdong Cao, MSc · Contactcaodd9612@163.com · 15519175632
    • Dongdong Cao, MSc · Principal investigator
    • Wengang Yang, MSc · Principal investigator
    • Mei Liu, BSc · Principal investigator
    • Zu Ma, BSc · Principal investigator
    • Qingsong Li, MD · Principal investigator
09

References and documents

Individual participant data

Plan to share: Yes — We will share the de-identified IPD that underlie the results reported in the publication, including baseline variables, randomization assignment, primary and secondary outcomes, and adverse events, together with a data dictionary. Data not required to reproduce the published results, such as [imaging data/genomic data/free-text fields], will not be shared.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.

Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's planned 24 months is below that.

Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 13, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Oct 30, 2028
CompletionEst.
Oct 30, 2029
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07936578
Lead sponsor
Guizhou Medical University
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Oct 30, 2028 (estimated)
Completion
Oct 30, 2029 (estimated)
Last update
Nov 13, 2026

Study contacts

Weiwei Ouyang, MD
Contact
ouyangww103173@163.com
18275356814
Weiwei Ouyang
principal investigator · the affiliated cancer hospital of guizhou medical university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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