CarcinomaPhase 1NCT07798921
JIN-A02 Plus Amivantamab in EGFR-Mutant NSCLC After Third-Generation EGFR-TKI Failure
A Phase 1 study testing JIN-A02 in Combination with Amivantamab in people with Carcinoma and Non-Small-Cell Lung, run by Yonsei University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- JIN-A02 in Combination with Amivantamab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2026to 31 Dec 2030
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 19 years or older.
- Subjects with advanced and/or metastatic NSCLC harboring an activating EGFR mutation (Ex19del or L858R), as confirmed by testing of tissue or blood samples, whose disease has progressed following treatment with a third-generation EGFR-TKI, such as osimertinib or lazertinib. Subjects who received platinum-based chemotherapy after EGFR-TKI treatment may have received no more than one such regimen.
- Subjects with at least one measurable lesion according to RECIST v1.1.
- Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- Subjects with NSCLC histologically diagnosed as having a mixed squamous cell component or with histologic transformation, including transformation from NSCLC to small cell lung cancer (SCLC) or the presence of epithelial-to-mesenchymal transition.
- Subjects with uncontrolled symptomatic spinal cord compression or central nervous system (CNS) metastases; subjects requiring an increase in corticosteroid dose within 28 days before study initiation for the treatment of CNS disease; subjects requiring local treatment for CNS disease; or subjects with leptomeningeal disease. However, subjects whose condition remains stable or who are systemically asymptomatic at least 2 weeks after gamma knife treatment or at least 4 weeks after whole-brain irradiation may be eligible to participate in the study.
- Subjects who have received any of the following treatments:
- EGFR-TKI therapy or systemic anticancer therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of the investigational product, or any prior treatment with a fourth-generation EGFR-TKI.
- Limited-field radiotherapy within 7 days or extended-field thoracic radiotherapy within 14 days before the first dose of the investigational product.
- Immunotherapy or other antibody-based therapy within 28 days before the first dose of the investigational product.
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- 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.
- Subjects with toxicities related to prior anticancer therapy or radiotherapy that have not recovered to CTCAE Grade ≤1 or baseline. Exceptions may be made for toxicities considered clinically acceptable by the investigator, such as alopecia or stable peripheral neuropathy.
- Subjects who have previously received amivantamab.
About this study
Official title: A Phase 1, Investigator-Initiated, Open-Label, Dose-Escalation Study to Evaluate the Safety, MTD, and Antitumor Activity of JIN-A02 in Combination With Amivantamab in EGFR-Mutant NSCLC Patients Following 3rd-Generation EGFR-TKI Failure
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- JIN-A02 in Combination with Amivantamab
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JIN-A02 in Combination with AmivantamabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| JIN-A02 Plus Amivantamab | Experimental | 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. Receives: Drug: JIN-A02 in Combination with Amivantamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through completion of the dose-escalation phase, approximately 8 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From the first dose through 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798921
- Sponsor's protocol ID
- 4-2026-0527
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Investigator-Initiated, Open-Label, Dose-Escalation Study to Evaluate the Safety, MTD, and Antitumor Activity of JIN-A02 in Combination With Amivantamab in EGFR-Mutant NSCLC Patients Following 3rd-Generation EGFR-TKI Failure
- ClinicalTrials.gov ID
- NCT07798921
- Acronym / sponsor ID
- 4-2026-0527
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Sep 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JIN-A02 Plus Amivantamab | Experimental | Drug: JIN-A02 in Combination with AmivantamabParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 19 years or older.
- Subjects with advanced and/or metastatic NSCLC harboring an activating EGFR mutation (Ex19del or L858R), as confirmed by testing of tissue or blood samples, whose disease has progressed following treatment with a third-generation EGFR-TKI, such as osimertinib or lazertinib. Subjects who received platinum-based chemotherapy after EGFR-TKI treatment may have received no more than one such regimen.
- Subjects with at least one measurable lesion according to RECIST v1.1.
- Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (10 listed)
- Subjects with NSCLC histologically diagnosed as having a mixed squamous cell component or with histologic transformation, including transformation from NSCLC to small cell lung cancer (SCLC) or the presence of epithelial-to-mesenchymal transition.
- Subjects with uncontrolled symptomatic spinal cord compression or central nervous system (CNS) metastases; subjects requiring an increase in corticosteroid dose within 28 days before study initiation for the treatment of CNS disease; subjects requiring local treatment for CNS disease; or subjects with leptomeningeal disease. However, subjects whose condition remains stable or who are systemically asymptomatic at least 2 weeks after gamma knife treatment or at least 4 weeks after whole-brain irradiation may be eligible to participate in the study.
- Subjects who have received any of the following treatments:
- 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.
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 |
|---|---|---|
| JIN-A02 in Combination with AmivantamabParticipants 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. | Drug | JIN-A02 Plus Amivantamab |
Primary outcome
Incidence of Dose-Limiting Toxicities
Time frame: During Cycle 1, up to 28 days after the first dose
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.
Maximum Tolerated Dose of JIN-A02 in Combination With Amivantamab
Time frame: Through completion of the dose-escalation phase, approximately 8 months
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.
Recommended Phase 2 Dose of JIN-A02 in Combination With Amivantamab
Time frame: Through completion of the dose-escalation phase, approximately 8 months
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.
3 secondary outcomes
Objective Response Rate According to RECIST Version 1.1
Time frame: From baseline until documented disease progression, up to approximately 2 years
Progression-Free Survival According to RECIST Version 1.1
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
Time frame: From the first dose through 30 days after the last dose
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 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JIN-A02 in Combination with Amivantamab in people with Carcinoma and Non-Small-Cell Lung, run by Yonsei University.
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 4 inclusion and 10 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (time frame: During Cycle 1, up to 28 days after the first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.