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New pill shows promise against tough lung cancer in early trial

NCT ID NCT05463224

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests a daily pill called lazertinib in 150 people with advanced non-small cell lung cancer that has specific EGFR mutations. The goal is to see how well the drug controls the cancer and delays its growth, while also checking for side effects. Participants have not had prior targeted therapy, and the study will also explore why the cancer might become resistant to the drug over time.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

150 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Dec 2027

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: * Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g. surgery or radiation). Patients who underwent curative intent surgery or definitive CRT and experience recurrence after 6 months are eligible. * Stage IIIC or IV by AJCC 8th edition * Confirmed EGFR mutations (exon 19 deletion, L858R)(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.) * Age of 19 or more. * Performance status of Eastern Cooperative Oncology Group 0 to 2. * Expected minimum life expectancy of 12 weeks * Adequate organ function. * Available to provide the adequate tissue and blood for the genomic tests- At least 15 unstained slide and 20 cc of blood at baseline (mandatory) and disease progression. * Agreed to perform re-biopsy at the timepoint of disease progression. * At least two weeks after the chemotherapy * Female subjects must either be of non-reproductive potential * Subject willing and able to comply with the protocol * Signed written informed consent Exclusion Criteria: * Previously treatment with any kind of EGFR TKI (Previously chemotherapy treated patients is allowed) * Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. (allowed for participation if investigator decided that previous malignancy is cured and not need for any additional treatment) * Uncontrolled central nervous system metastases- patient with asymptomatic brain metastases or CNS symptom manageable with TKI and evaluated by investigator can be enrolled. * Spinal cord compression, leptomeningeal carcinomatosis * Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection * Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week * Any unresolved toxicities from prior therapy, greater than CTCAE grade 1 * Mean QT interval corrected for heart rate (QTc) ≥ 470 ms * No measurable lesion * Unable to swallow the product due to refractory nausea, vomiting or chornic gastrointestinal disease.

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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.

Contacts and locations

Locations

  • Samsung Medical Center

    Seoul, Gangnamgu, 06351, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.