New hope for lung cancer: targeted pill tested after other treatments fail
NCT ID NCT05297890
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing the drug lorlatinib in about 70 Chinese patients with advanced ROS1-positive non-small cell lung cancer that has worsened after prior treatments (crizotinib and chemotherapy). The goal is to see how many patients respond to the drug and how long the response lasts. Lorlatinib is taken as a daily pill, and the study is open-label (everyone knows they are getting the drug).
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, lorlatinib could offer a new treatment option for people with ROS1-positive lung cancer whose disease has worsened after other therapies.
- What could go wrong
- This is a small, early-phase study (70 people) with no comparison group, so results may not apply broadly. Side effects from lorlatinib are possible, and the drug may not work for everyone.
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
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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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70 people
The number who actually took part.
- Started
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May 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: * Subjects with histologically or cytologically confirmed diagnosis of locally advanced or metastatic ROS1 gene arrangement positive NSCLC. * Subject should have radiological disease progression while on treatment with crizotinib as the only prior ROS1 inhibitor. * Participants must have been treated with platinum-based doublet chemotherapy for locally advanced/metastatic disease for at least 1 cycle and must have radiological disease progression on or after that. Participants who do not tolerate platinum-based doublet chemotherapy may be included provided they have been treated for at least 1 cycle. * Prior treatment with small molecules or cytotoxic agents must have completed ≥5 half-lives prior to initiating study treatment; Prior treatment with antibodies must have completed at least 3 weeks prior to initiating study treatment. * All Subjects must have at least 1 measurable target lesion (intracranial or extracranial) according to RECIST v1.1. * Eastern Cooperative Oncology Group performance status (ECOG PS) 0, 1, or 2. * Age ≥18 years. * Subjects must have adequate organ function as assessed in the laboratory tests. * Acute effects of prior anti-cancer treatment resolved to baseline severity or to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 except for AEs that in the investigator's judgment do not constitute a safety risk for the subject. * Serum or urine pregnancy test (for females of childbearing potential) negative at screening. * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * Willing and able to comply with the study scheduled visits, treatment plans, laboratory tests, and other procedures. Exclusion Criteria: * More than 1 prior chemotherapy regimen prior to enrollment in the locally advanced/metastatic setting. * Subject's cancer has a known primary driver alteration other than ROS1 gene rearrangement. * Major surgery within 4 weeks prior to the first dose. * Radiation therapy within 2 weeks prior to the first dose. Palliative radiation must have been completed at least 48 hours prior to the first dose. Stereotactic or partial brain irradiation must have completed at least 2 weeks prior to the first dose. Whole brain irradiation must have completed at least 4 weeks prior to the first dose. * Spinal cord compression unless the subject has good pain control attained through therapy, and there is complete recovery of neurological function for the 4 weeks prior to the first dose. * Gastrointestinal abnormalities, including inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection or lap band; active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer disease in the past 6 months; malabsorption syndromes. * Known prior or suspected severe hypersensitivity to lorlatinib or any component in the formulation; known prior therapy with lorlatinib. * Severe acute or chronic infections. * Clinically significant cardiovascular disease (both arterial and venous) and non-vascular cardiac conditions (active or within 3 months prior to the first dose). * Subject with predisposing characteristics for acute pancreatitis according to investigator judgment, including but not limited to uncontrolled hyperglycemia, current gallstone disease, in the last month prior to the first dose. * History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis. * Evidence of active malignancy within the last 3 years prior to the first dose. * Concurrent use of any of the prohibited food or drugs required in protocol within 12 days prior to the first dose of administration of lorlatinib. * Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, would make the subject inappropriate for entry into this study. * Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation. * Pregnant female subjects; breastfeeding female subjects. * Any use of traditional Chinese medicines or herbal preparations with anti-tumor indications within 7 days before the first dose of investigational product.
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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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Beijing Cancer Hospital
Beijing, China
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
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Chinese PLA Army Medical Center
Chongqing, China
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Fudan University Shanghai Cancer Center
Shanghai, China
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Fujian Cancer Hospital
Fuzhou, China
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Guangdong Provincial People's hospital
Guangzhou, Guangdong, 510080, China
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Harbin Medical University Cancer Hospital
Harbin, China
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Henan Cancer Hospital
Zhengzhou, China
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Henan Provincial People's Hospital
Zhengzhou, China
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Hunan Cancer Hospital
Changsha, China
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Jiangsu Province Hospital
Nanjing, China
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Liaoning Cancer Hospital and Institute
Shenyang, China
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Shandong Cancer Hospital&Institute
Jinan, China
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Shanghai Pulmonary Hospital
Shanghai, China
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Shanxi Cancer hospital
Taiyuan, China
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Sichuan Cancer Hospital & Institute
Chengdu, China
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Sun Yat-sen University Cancer Center
Guangzhou, China
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Tangdu Hospital of The fourth Military Medical University Peoples Liberation Army of China
Xi'an, China
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The 1st Affiliated hospital of Wenzhou Medical University
Wenzhou, China
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The First Affiliated Hospital of Anhui Medical University
Hefei, China
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The First Affiliated Hospital of Nanchang University
Nanchang, China
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
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The First Hospital of Jilin University
Changchun, China
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The Second Affiliated Hospital of Nanchang University
Nanchang, China
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The first Affiliated hospital, Sun Yat-Sen University
Guangzhou, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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West China Hospital of Sichuan University
Chengdu, China
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Xiamen Humanity Hospital
Xiamen, China
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Yunnan Cancer Hospital
Kunming, China
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Zhejiang Cancer Hospital
Hangzhou, China