New pill shows promise against tough lung cancer in early trial
NCT ID NCT05463224
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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150 people
The number who actually took part.
- Started
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Jan 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Samsung Medical Center
Seoul, Gangnamgu, 06351, South Korea
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