Actively Recruiting
Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC
Led by Guangdong Association of Clinical Trials · Updated on 2023-10-23
126
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II study is aim to investigate the efficacy, resistance mechanism, safety profile of first-line lorlatinib in China advanced ALK+ non-small cell lung cancer (NSCLC). Participants will receive continuous daily PO dosing of lorlatinib 100mg QD.
CONDITIONS
Official Title
Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed advanced ALK-positive NSCLC based on specific diagnostic tests
- At least 1 extracranial measurable target lesion that has not been previously irradiated
- CNS metastases allowed if asymptomatic and meeting specific corticosteroid and treatment conditions
- Available archival tissue specimen or mandatory new biopsy before randomization
- No prior systemic treatment for advanced or metastatic NSCLC including targeted agents, immunotherapy, or chemotherapy
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- Age 18 years or older
- Adequate bone marrow, pancreatic, renal, and liver function as defined by specific laboratory values
- Prior radiotherapy effects resolved to baseline or mild severity without safety risk
- Negative serum pregnancy test for females of childbearing potential
- Female patients of non-childbearing potential must meet specific criteria related to menopause or reproductive status
- Signed informed consent indicating understanding of the study
- Willing and able to comply with scheduled visits, treatments, and tests
- Compassionate use cohort: diagnosed ALK-positive NSCLC not meeting some CROWN criteria
- No prior ALK TKI treatment for advanced or metastatic disease
- Negative serum pregnancy test for females of childbearing potential
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Spinal cord compression without good pain control and neurological stability
- Major surgery within 4 weeks prior to randomization
- Radiation therapy within 2 weeks prior to randomization or recent whole brain or palliative radiation
- Gastrointestinal conditions affecting oral medication absorption or recent active peptic ulcer disease
- Known severe hypersensitivity to study drugs or components
- Active bacterial, fungal, or viral infections including hepatitis B, hepatitis C, or HIV/AIDS
- Significant vascular or non-vascular cardiac conditions within 3 months prior to enrollment
- Predisposing factors for acute pancreatitis in the last month
- History of severe interstitial lung disease or related pulmonary conditions
- Active malignancies other than specific exceptions within the last 3 years
- Concurrent use of strong CYP3A inhibitors, inducers, or substrates with narrow therapeutic index within 12 days prior to dosing
- Other severe acute or chronic medical or psychiatric conditions increasing study risk or interfering with results
- Investigational site staff or Pfizer employees involved in the study and their family members
- Participation in other investigational drug studies within 2 weeks prior to or during this study
- Pregnant or breastfeeding women and those unwilling or unable to use highly effective contraception as required
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial Perople's Hospital
Guangzhou, Guangdong, China, 023187
Actively Recruiting
Research Team
J
Jiaxin Lin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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