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RECRUITINGPHASE2

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

Molecular Characterization and Clinical Outcomes of ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma

NCT05014464•Hunan Province Tumor Hospital

View on ClinicalTrials.gov

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.

Detailed Description

This research focuses on exploring epidemiology, distributions and the efficacy and prognosis 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. Several studies have shown that in patients with ALK-rearranged non-small cells, the use of ALK inhibitors can achieve better efficacy and significantly prolong overall survival. However few of them performed Fish or NGS tests. Our data demonstrates that lung squamous cell carcinoma with ALK rearrangement responds well to ALK-TKI, and correspondingly has a significant improvement in survival time and prognosis, providing a basis for the treatment of ALK-positive patients with lung squamous cell carcinoma. At the same time, we believe that genetic testing is also required for lung squamous cell carcinoma to achieve more accurate medication.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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 more criteria

Locations (1)

Hunan Cancer Hospital

Changsha, Hunan, China

Key Dates

Start Date

November 13, 2021

Primary Completion Date

June 1, 2026

Completion Date

August 8, 2027

Last Updated

September 20, 2024

Enrollment

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer

Interventions

Crizotinib

DRUG

Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436 zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613873123436 yangnong0217@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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