A Phase 1 interventional study of JIN-A02 in Combination with Amivantamab in Carcinoma and Non-Small-Cell Lung, sponsored by Yonsei University. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Yonsei University · Phase 1, Interventional, and Treatment
This Phase 1 study will evaluate the safety, maximum tolerated dose, recommended Phase 2 dose, and preliminary antitumor activity of JIN-A02 in combination with amivantamab in participants with advanced EGFR-mutant non-small cell lung cancer whose disease has progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor.
The study includes a dose-escalation phase and a dose-expansion phase. During dose escalation, participants will receive oral JIN-A02 once daily at planned dose levels of 120 mg, 160 mg, or 200 mg in combination with weight-based intravenous amivantamab. Dose escalation will follow a Bayesian optimal interval design, and dose-limiting toxicities during the first 28-day treatment cycle will be used to determine the maximum tolerated dose and recommended Phase 2 dose.
After the recommended Phase 2 dose is determined, additional participants will be enrolled in the dose-expansion phase to further evaluate safety and preliminary antitumor activity. Efficacy assessments will include objective response rate and progression-free survival according to RECIST version 1.1. Exploratory analyses may evaluate changes in EGFR mutations and resistance-associated genomic alterations using circulating tumor DNA collected before and during treatment and at the end of treatment.
736 studies on the registry are indexed under Carcinoma; 149 are open to participants now.
This study's planned enrollment of 36 is below the median of 49 across 571 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Subjects who have received any of the following treatments:
Major surgery, other than procedures such as central venous catheter placement, within 28 days before the first dose of the investigational product, or subjects who, in the investigator's judgment, have not recovered from surgery-related adverse effects.
*Major surgery is defined as surgery involving the abdominal, pelvic, cranial, thoracic, or localized tissues that, considering the surgical site, the subject's condition, the complexity of the procedure, or the duration of surgery, may pose a risk to organ or tissue function or to resuscitation. Major surgery generally requires general anesthesia, hospitalization of varying duration, often approximately 1 week, and may be performed by a surgical specialist.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Participants will receive JIN-A02 orally once daily in combination with intravenous amivantamab in 28-day treatment cycles during the dose-escalation and dose-expansion phases.
Drug: JIN-A02 in Combination with Amivantamab
Drug page: Amivantamab
Participants will receive oral JIN-A02 once daily in continuous 28-day treatment cycles in combination with intravenous amivantamab. During dose escalation, the planned JIN-A02 dose levels are 120 mg, 160 mg, and 200 mg once daily. Amivantamab will be administered at 1,050 mg for participants with a baseline body weight of less than 80 kg or 1,400 mg for participants weighing 80 kg or more. The first amivantamab dose will be split between Cycle 1 Days 1 and 2, followed by administration on Days 8, 15, and 22 of Cycle 1 and every 2 weeks from Cycle 2 onward. On combination-treatment days, JIN-A02 will be administered within approximately 15 minutes before amivantamab.
Incidence of Dose-Limiting Toxicities
The incidence of dose-limiting toxicities will be evaluated during the first 28-day treatment cycle. Dose-limiting toxicities will be defined and graded according to the criteria specified in the protocol.
Time frame: During Cycle 1, up to 28 days after the first dose
Maximum Tolerated Dose of JIN-A02 in Combination With Amivantamab
The maximum tolerated dose will be determined based on dose-limiting toxicities observed during Cycle 1 and dose-escalation decisions made according to the Bayesian optimal interval design.
Time frame: Through completion of the dose-escalation phase, approximately 8 months
Recommended Phase 2 Dose of JIN-A02 in Combination With Amivantamab
The recommended Phase 2 dose will be determined based on the totality of available safety, tolerability, pharmacokinetic, and preliminary antitumor activity data from the dose-escalation phase.
Time frame: Through completion of the dose-escalation phase, approximately 8 months
Objective Response Rate According to RECIST Version 1.1
Objective response rate is defined as the proportion of participants with a confirmed best overall response of complete response or partial response according to RECIST version 1.1. Tumor assessments will be performed at baseline, every 8 weeks from Cycle 3 Day 1 through 1 year after the first dose, and every 12 weeks thereafter until disease progression. For participants with long-term stable disease, assessments may be performed every 16 weeks.
Time frame: From baseline until documented disease progression, up to approximately 2 years
Progression-Free Survival According to RECIST Version 1.1
Progression-free survival is defined as the time from the first dose of study treatment to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Participants without documented disease progression at the End-of-Treatment visit will continue progression-free survival follow-up every 12 weeks.
Time frame: From the first dose until documented disease progression or death from any cause, whichever occurs first, up to approximately 2 years
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability will be assessed based on the incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse events and serious adverse events. Safety assessments will also include clinical laboratory tests, vital signs, physical examinations, 12-lead electrocardiograms, and other protocol-specified evaluations.
Time frame: From the first dose through 30 days after the last dose
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Amivantamab