New targeted pill may keep ALK lung cancer in check after standard treatment
NCT ID NCT07235306
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the targeted drug ensartinib can help people with ALK-mutated stage III lung cancer that cannot be removed by surgery. After completing standard chemoradiotherapy, 45 participants will receive either ensartinib or a placebo to see if the drug delays cancer growth. The goal is to improve disease control without a cure, as ongoing treatment is needed.
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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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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
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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18 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: * Male or female aged at least 18 years * Histologically or cytologically confirmed Stage III unresectable non-small cell lung cancer (NSCLC) with curative treatment intent * ALK mutations assessed by FISH, IHC, or NGS * ECOG Performance Status of 0 or 1 * Completion of platinum-based concurrent or sequential chemoradiotherapy as per protocol requirements * Chemoradiotherapy must have been completed ≤ 6 weeks prior to randomization * No disease progression during or after chemoradiotherapy * Life expectancy \> 12 weeks * Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment * Signed informed consent form obtained from the patient or their legally authorized representative * Male and female patients of childbearing potential agree to use highly effective contraception methods from before entering the trial, throughout the study, and until 8 weeks after discontinuation of study treatment Exclusion Criteria: * Mixed histology of small cell and non-small cell lung cancer * Symptomatic pneumonitis following chemoradiotherapy that has not resolved to ≤ Grade 1 (per CTCAE criteria) prior to randomization; * Any unresolved toxicity from prior chemoradiotherapy with toxicity ≥ Grade 2 (according to CTCAE criteria); * Poor cardiac function, including but not limited to any of the following: * Mean resting corrected QT interval (QTc) \> 470 msec (obtained from 3 ECGs); * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; * Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or concomitant use of any known drugs that prolong the QT interval and may lead to Torsades de Pointes; * Inadequate bone marrow reserve or organ function; * History of other malignant malignancies, except for adequately treated non-melanoma skin cancer or malignant lentigo, cured carcinoma in situ, or other solid tumors cured \> 5 years ago with no evidence of disease and considered by the treating physician to have a low risk of recurrence; * Severe or uncontrolled systemic diseases: including uncontrolled hypertension and active bleeding tendency; or active infections, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV); * Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of ensartinib; * Any prior chemotherapy, radiotherapy, immunotherapy, or investigational drug therapy beyond the definitive treatment for locally advanced disease; * Prior treatment with any ALK tyrosine kinase inhibitor (ALK-TKI); * Major surgery within 4 weeks prior to the first dose of study drug; * Current use of medications known to be strong inducers of CYP3A4 (which cannot be discontinued at least 3 weeks prior to the first dose of study drug); * Known hypersensitivity to ensartinib or any excipient in this product; * Pregnant or lactating women; * History of definite neurological or psychiatric disorders, including epilepsy or dementia; * Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation in the study.
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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.
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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.
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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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