A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer
NCT ID: NCT05297890
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2022-05-27
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lorlatinib
Drug：Lorlatinib 100mg, oral, Quaque Die (QD), continuous administration in 21 days as a cycle
Lorlatinib
Dosage Form: Lorlatinib tablet, Dosage: 25mg/tablet, Dosing Regimens: 100mg, oral, Quaque Die (QD), continuous administration in 21 days as a cycle
Interventions
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Lorlatinib
Dosage Form: Lorlatinib tablet, Dosage: 25mg/tablet, Dosing Regimens: 100mg, oral, Quaque Die (QD), continuous administration in 21 days as a cycle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
CStone Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Guangdong Provincial People's hospital
Guangzhou, Guangdong, China
Beijing Cancer Hospital
Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
Sichuan Cancer Hospital & Institute
Chengdu, , China
West China Hospital of Sichuan University
Chengdu, , China
Chinese PLA Army Medical Center
Chongqing, , China
Fujian Cancer Hospital
Fuzhou, , China
Sun Yat-sen University Cancer Center
Guangzhou, , China
The first Affiliated hospital, Sun Yat-Sen University
Guangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
The First Affiliated Hospital of Anhui Medical University
Hefei, , China
Shandong Cancer Hospital&Institute
Jinan, , China
Yunnan Cancer Hospital
Kunming, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Jiangsu Province Hospital
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Liaoning Cancer Hospital and Institute
Shenyang, , China
Shanxi Cancer hospital
Taiyuan, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
The 1st Affiliated hospital of Wenzhou Medical University
Wenzhou, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Tangdu Hospital of The fourth Military Medical University Peoples Liberation Army of China
Xi'an, , China
Xiamen Humanity Hospital
Xiamen, , China
Henan Cancer Hospital
Zhengzhou, , China
Henan Provincial People's Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Other Identifiers
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CS3011-201
Identifier Type: -
Identifier Source: org_study_id