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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.

• Age ≥ 18 years.

• Histopathology or cytology confirmed and recorded local progression or metastatic Advanced Squamous Cell Carcinoma without systemic treatment.

• ALK fusion positive evaluated by IHC (ventana), NGS or FISH.

• ECOG 0 - 1.

• Predicted survival ≥ 12 weeks.

• Adequate bone marrow hematopoiesis and organ function

• Presence of measurable lesions according to RECIST 1.1.

• Subjects with stable brain metastases may be included in the study.

Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
Contact Information
Primary
Yongchang Zhang, MD
zhangyongchang@csu.edu.cn
+8613873123436
Backup
Nong Yang, MD
yangnong0217@163.com
+8613873123436
Time Frame
Start Date: 2021-11-13
Estimated Completion Date: 2027-08-08
Participants
Target number of participants: 90
Treatments
Experimental: Cohort A, first line ALK-TKIs
All the patients were treated with first line ALK-TKis including Crizotinib, Alectinib, Brigatinib and Lorlatinib etc. Approximately 30 patients.
Experimental: Cohort B, second line ALK-TKIs
All the patients were treated with second line ALK-TKis including Crizotinib, Alectinib, Brigatinib and Lorlatinib etc. Approximately 30 patients.
Experimental: Cohort C, post second line ALK-TKIs
All the patients were treated with post second ALK-TKis including Crizotinib, Alectinib, Brigatinib and Lorlatinib etc. Approximately 30 patients.
Sponsors
Leads: Hunan Province Tumor Hospital

This content was sourced from clinicaltrials.gov