Targeted pill may shrink lung tumors before surgery in new trial
NCT ID NCT05740943
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether taking the targeted drug lorlatinib for three months before surgery can shrink tumors in people with stage III ALK-positive non-small cell lung cancer. The study involves 48 participants and aims to see if the drug can eliminate all signs of cancer in the removed tissue. It also explores how genetic testing in the blood can help guide treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lorlatinib (a targeted cancer pill)
- What this could lead to
- If successful, this approach could shrink advanced lung tumors enough to allow surgery, potentially improving long-term control of the disease.
- What could go wrong
- This is a small, early-phase trial with only 48 participants. It is not yet proven to work better than standard treatment, and side effects from lorlatinib or surgery are possible.
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
-
About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2023
- Expected to finish
-
Apr 2026
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
-
18 to 75 years
- 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 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: * Age :18 Years to 75 Years; * ECOG physical score 0-2 points; expected survival time ≥ 1 year; * Pathologically confirmed diagnosis with Stage III NSCLC which harbored ALK fusion detected by next generation sequencing (NGS) or immunohistochemistry (IHC) with or without FISH. Suspected N2 (station 2/4/7) for stage III disease should be confirmed by either mediastinoscopy or EBUS. * At least one measurable target lesion according to the RECIST 1.1 standard; * The main organ function meets the following criteria: 1) blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L; 2) blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal; * Subjects voluntarily joined the study and signed informed consent, with good compliance to follow-up. Exclusion Criteria: * Stage I, stage II and metastatic stage IV NSCLC; * Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer); * Patients who have previously used any other anti-tumor drugs or received surgery/radiotherapy; * Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease or serious infections. * Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy; * Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; * Patients with low compliance or willingness to take the drugs and surveillance.
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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
-
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
-
Guangzhou Twelfth People's Hospital
Guangzhou, Guangdong, China
-
Peking Union Medical College Hospital
Beijin, Beijin, 100730, China
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The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
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