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Recruiting Phase 2

ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma

NCT05014464 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2021-11-13
Last updated
2024-09-20

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Crizotinib →

Crizotinib: Crizotinib 250mg po bid Aectinib 600mg po bid Lorlatinib 100mg po qd Brigatinib, 90mg po qd for one week and than 180mg po qd forever Pemetrexed 500mg/m2

Study summary

This study was to explore the efficacy of ALK-TKI in lung squamous cell carcinoma. Approximately 5% of lung adenocarcinomas have oncogenic fusions of EML-4 and ALK a mutation associated with tumorigenesis and migration.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. Age ≥ 18 years. 3. Histopathology or cytology confirmed and recorded local progression or metastatic Advanced Squamous Cell Carcinoma without systemic treatment. 4. ALK fusion positive evaluated by IHC (ventana), NGS or FISH. 5. ECOG 0 - 1. 6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1. 9. Subjects with stable brain metastases may be included in the study. Exclusion Criteria: 1. Prior systemic therapy for locally advanced or metastatic disease. 2. Subjects who have received any of the following treatments must be excluded: * Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug. * Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose. * Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose. 3. Presence of spinal cord compression or meningeal metastasis. 4. History of other malignant tumors within 2 years. 5. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose. 6. History of stroke or intracranial hemorrhage within 6 months prior to the first dose. 7. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator. 8. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection. 9. Heart-related diseases or abnormalities 10. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy. 11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection. 12. Live vaccine was given 2 weeks before the first medication. 13. Women who are breastfeeding or pregnant. 14. Hypersensitivity to the test drug and the ingredients. 15. Other conditions assessed by the investigator to be unsuitable for participation in the study.

Primary outcome measure(s)

  • Progression-free survival (PFS) — Time from first subject dose to study completion, or up to 36 month
    To assess progression-free survival of patients treated by different treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause

Trial sites (1)

FacilityCityRegionStatus
Hunan Cancer Hospital Changsha Hunan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05014464 on ClinicalTrials.gov ↗ ← All trials in China