A Phase 1/2 interventional study of TXN10128 in NSCLC (Non-small Cell Lung Cancer), sponsored by Txinno Bioscience Inc.. Recruiting at 8 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Txinno Bioscience Inc. · Phase 1/2, Interventional, and Treatment
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Among 700 studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of — 123 open to participants now, 264 under way, 101 of them phase 3. Carcinoma, Non-Small-Cell Lung · Korea, Republic of.
Among the 700 studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of, this one is the 456th largest by planned enrollment of the 657 interventional ones that give a count, is one of 22 that started in 2026, is one of 84 in phase 1/2, reaches primary completion later than 190 of the 263 other live ones, and was the 699th registered.
7,621 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,836 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →123 of the 700 studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in Korea, Republic of, United States, Argentina and 16 more countries
Ages 18+
Eun Hye Lee · Sites in Korea, Republic of
Ages 19+
Bristol-Myers Squibb · Sites in Korea, Republic of, United States, Argentina and 13 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in Korea, Republic of, United States, Canada and 3 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in Korea, Republic of, United States, Argentina and 15 more countries
Ages 18+
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 1,327 Carcinoma, Non-Small-Cell Lung studies recruiting now, 989 (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: 19 Years and older · 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.
700 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 194 · Phase 2 313 · Phase 3 232 · Phase 4 6
First in 1994; this study’s year is marked. 22 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 104 is above the median of 62 across 6,020 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 200 across the 657 interventional studies, 339 across the 39 observational. Of the 373 that completed or were terminated, 230 (62%) have results posted.
This tab as a report to print or save as PDF → With an account.
571 of 700 have an industry lead sponsor. The 10 most frequent:
Txinno Bioscience Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Txinno Bioscience Inc. has 1 study filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
64 of the studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of that are under way reach primary completion within a year, 18 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT06430866Phase 3AmgenPharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) | 2026-12-14 |
| NCT05221840Phase 3AstraZenecaA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | 2027-01-08 |
| NCT06417814Phase 3AstraZenecaA Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2027-01-11 |
| NCT05609968Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46) | 2027-01-12 |
Add all 64 to your calendar (.ics) → With an account.
Among the 700 studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a multicenter, open-label, multi-cohort, Phase 1b/2 clinical study. This study evaluates TXN10128 in combination with either irinotecan (a topoisomerase I inhibitor) or a TROP2-directed antibody-drug conjugate (TROP2 ADC) in participants with advanced or metastatic NSCLC with confirmed EGFR mutations.
The study consists of three cohorts. It enrolls participants who have progressed after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based doublet chemotherapy.
Part B enrolls participants who are currently receiving TROP2 ADC therapy or whose disease has progressed following such therapy (with no restriction on the number of prior lines).
In Part C, participants who are naïve to TROP2 ADC therapy and have received no more than three prior lines of systemic anticancer therapy will be enrolled. A safety run-in will first be conducted to confirm the safety of the combination with a TROP2 ADC. Based on the results, the Safety Review Committee (SRC) will select the recommended dose for expansion phase, which will follow Simon's two-stage design.
Participants with advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring epidermal growth factor receptor (EGFR) mutations 3.1 Number of targeted participants Part A (Main Cohort): Approximately 45 participants (including a 10% dropout rate) Part B (Exploratory Cohort): Approximately 15 participants Part C (Expansion Cohort): about 44 participants (including a 10% dropout rate)
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.
They must also meet the prior treatment requirements for each cohort.
* EGFR TKI-sensitizing mutations: mutations that are highly responsive to TKIs, such as exon 19 deletion or exon 21 L858R point mutation.
3) Participants who have experienced disease progression on or after prior third-generation EGFR TKI therapy, either during or after treatment, and who meet the following criteria
(1) Part A:
Have received no more than four* prior lines of anticancer therapy, including one platinum-based doublet chemotherapy regimen.
(2) Part B: Prior treatment with a TROP2 ADC (3) Part C:
Have received no more than three* prior lines of anticancer therapy, including one platinum-based doublet chemotherapy regimen
*Counting of prior lines of anticancer therapy and adjuvant anticancer therapies are, in principle, not counted as prior lines. However, if disease recurrence or progression occurs within 6 months after completion of adjuvant therapy, such therapy will be counted as a prior line.
4) Participants with documented evidence of an EGFR TKI-sensitizing mutation in the tumor, as confirmed by liquid or tissue biopsy performed prior to enrollment in this study, with the result* properly documented
*EGFR mutation testing must be performed using a validated polymerase chain reaction (PCR) or next-generation sequencing (NGS) assay at an appropriately certified/accredited laboratory (e.g., a study specimen analysis facility or a laboratory holding a clinical laboratory standard accreditation).
5) Participants with at least one per v1.1. If the participant has received prior radiotherapy, the measurable lesion must be located outside the prior radiation field unless there is clear evidence of progression of a lesion within the irradiated field.
6) Participants who agree to provide either: a fresh tumor biopsy (core needle biopsy or excisional biopsy) obtained before the first dose of TXN10128 (C1D1), or an archival tumor specimen collected after the most recent prior anticancer therapy.
7) Participants with an (ECOG) performance status (PS) of 0 or 1.
8) Participants with a of at least 12 weeks. 9) Adequate hematologic and adequate major organ/cardiac function, as defined by the following laboratory results obtained within 7 days prior to the first dose of TXN10128 (C1D1):
Adequate bone marrow function*: count ≥100,000/mm³, (Hb) ≥10 g/dL, (ANC) ≥1,500/mm³.
* Hematologic parameters must be met without transfusion, granulocyte colony-stimulating factor (G-CSF), or other hematopoietic growth factor support within 1 week prior to the relevant laboratory assessment.
10) Recovery from adverse events (AEs) of prior therapy to Grade ≤1 (except for alopecia or stable Grade 2 peripheral neuropathy).
11) For participants of , agreement to practice adequate abstinence and , and agreement not to donate ova or sperm. Males and females of must agree to use one of the following medically acceptable methods of contraception from the last dose of TXN10128 through 28 weeks after the last dose.
Complete abstinence from sexual intercourse is also acceptable when, in the investigator's judgment, the participant's age, occupation, lifestyle, or sexual orientation assures contraception. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods), abstinence, and withdrawal are not considered acceptable methods of contraception.
12) Participants who are willing and able to comply with the procedures required by this clinical study protocol, including hospitalization, procedures and interventions, tumor biopsy (core needle biopsy or excisional biopsy), and laboratory tests, and who have voluntarily provided written informed consent.
Exclusion Criteria:
1) Participants with any of the following concurrent medical conditions:
However, at the investigator's discretion, participants may be enrolled if they meet any of the following:
- Neurologically stable that have either been off for at least 4 weeks prior to the first dose of TXN10128 or have been maintained on a stable dose of corticosteroids [hydrocortisone ≤30 mg/day, dexamethasone ≤2 mg/day, or prednisone ≤10 mg/day (or equivalent)].
- At least 2 weeks have elapsed since the completion of brain radiotherapy. (3) confirmed (4) coagulation disorders, including disseminated intravascular coagulation (DIC).) (5) Participants with histologically mixed small cell lung cancer (SCLC) and NSCLC.
(6) Uncontrolled diarrhea of Grade ≥2 per version 6.0 2) Participants with any of the following medical history:
Clinically significant (e.g., active) cardiovascular disease within 24 weeks prior to the first dose of TXN10128 (C1D1):
- History of long syndrome;
3) Participants who have received any of the following treatments:
Use of the following anticancer therapies within the specified timeframes prior to the first dose of TXN10128 (C1D1):
- Cytotoxic chemotherapy, targeted therapy, or hormonal therapy within 2 weeks; however, nitrosourea or mitomycin administered within 6 weeks prior to the first dose;
- Prior antibody or protein-based immunotherapy, or IP within 4 weeks;
4) Participants with a history of to the combination anticancer therapy, any of its components, or agents of similar class, including anaphylaxis/anaphylactoid reactions and angioedema, or who have any other to treatment.
5) Pregnant or lactating women. 6) Participants who, in the opinion of the investigator, are not suitable for study participation [Part A, B] 7) Participants who are homozygous (UGT1A1*6/*6, UGT1A1*28/*28) or compound heterozygous (UGT1A1*6/*28) for UGT1A1*6 or UGT1A1*28.
8) Participants who are receiving atazanavir sulfate.
[Part C] 9) Clinically significant corneal disease that may affect treatment or assessment, as judged by the investigator.
10) Participants who, at screening, are receiving strong inhibitors (e.g., cyclosporine, verapamil) or inducers of major drug transporters (P-gp, OATP1B1/1B3, BCRP, MRP1, MATE2-K), and who require continuation of such agents during the study period.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
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.
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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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).
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.
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.
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.
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.
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.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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 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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TXN10128 in combination with irinotecan in participants who had not previously received a TROP2 ADC.
Drug: TXN10128
TXN10128 in combination with irinotecan in participants who had previously received a TROP2 ADC.
Drug: TXN10128
TXN10128 in combination with TROP2 ADC in participants who had not previously received a TROP2 ADC.
Drug: TXN10128
oral ENPP1 inhibitor
Progression Free Survival
By central independent reviewer
Time frame: From enrollment until disease progression or the end of the study; tumor assessments every 8 weeks through Week 24 and every 12 weeks thereafter.
objective Response Rate
By central independent reviewer
Time frame: From enrollment until disease progression or the end of the study; tumor assessments every 8 weeks through Week 24 and every 12 weeks thereafter.
Disease Control Rate
By central independent reviewer
Time frame: From enrollment until disease progression or the end of the study; tumor assessments every 8 weeks through Week 24 and every 12 weeks thereafter.
Plan to share: Undecided
Started Oct 2026 (actual). Primary completion is estimated for Sep 2028, 23 months after the start.
Of 309 industry-sponsored phase 1/2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 77. This study's planned 23 months is below that.
Counting every sponsor, half of 432 studies reached it within 63 months; a quarter within 42 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Carcinoma, Non-Small-Cell Lung →
Txinno Bioscience Inc.