Can a two-drug combo outsmart resistant lung cancer?

NCT ID NCT07798921

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This phase 1 trial tests whether combining an experimental oral drug, JIN-A02, with an existing intravenous drug, amivantamab, is safe and can shrink tumors in people with advanced EGFR-mutant non-small cell lung cancer that has progressed after treatment with a third-generation EGFR inhibitor. The study enrolls about 36 adults and first finds the safest dose, then checks how well the combination works. Researchers also look for changes in tumor DNA in the blood to understand resistance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JIN-A02 (oral drug) combined with amivantamab (intravenous drug)
What this could lead to
If it works, this combination could offer a new treatment option for people with EGFR-mutant lung cancer whose tumors stop responding to current targeted therapies.
What could go wrong
This is an early, small phase 1 trial focused on safety and dosing, so it may not lead to an approved treatment. The combination may cause side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects aged 19 years or older. 2. 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. 3. Subjects with at least one measurable lesion according to RECIST v1.1. 4. Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: 1. 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. 2. 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. 3. Subjects who have received any of the following treatments: 1. 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. 2. Limited-field radiotherapy within 7 days or extended-field thoracic radiotherapy within 14 days before the first dose of the investigational product. 3. Immunotherapy or other antibody-based therapy within 28 days before the first dose of the investigational product. 4. 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. 5. 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. 6. Subjects who have previously received amivantamab.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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