ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma
ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Prior systemic therapy for locally advanced or metastatic disease.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Crizotinib
DrugCrizotinib 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
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Cohort A, first line ALK-TKIsExperimental treatment 1 intervention
Group B: Cohort B, second line ALK-TKIsExperimental treatment 1 intervention
Group C: Cohort C, post second line ALK-TKIsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
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
Time frame
Time from first subject dose to study completion, or up to 36 monthSecondary outcomes
1
Overall survival (OS)
To assess overall survival, define as first dose to the death of the subject due to any cause
Time frame
Time from first subject dose to study completion, or up to 36 month.2
Objective Response Rate (ORR)
To assess ICI and TKIs overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Time frame
Time from first dose to last dose, or up to 24 month.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov