Clinical trial · Observational
Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
NCT04317651CI-TRIAL-00044240SPECIALKunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, observational, retrospective cohort study aimed at assessing the efficacy and safety of crizotinib in ALK positive NSCLC treated in real life setting.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sistematic review of medical records
- timeFrame
- Six months
- description
- To assess the overall efficacy of crizotinib (250 mg/bid) in terms of Response rate, Progression-Free Survival and Overall Survival in the treatment of NSCLC in real life setting. Median PFS, as reported by a recent metanalysis, is 9.4 months (first and second line together) corresponding to a 12 months PFS rate of about 40%. The analysis of 500 patients will allow to estimate the median PFS with a semi-width 95% confidence interval of 1.2 months. OS will be calculated from the first day of treatment until the date of death from any cause. Any patient not known to have died at the time of data analysis will be censored at the time of the last recorded date on which the patient was known to be alive. Time to events will be summarized using Kaplan-Meier estimation. ORR, defined as the proportion of patients with a best overall response of either Complete response or Partial response, will be calculated based on disease status evaluated by the investigator according to RECIST v1.1
Secondary outcomes (1)
- measure
- Secondary Objectives
- timeFrame
- Six months
- description
- 1. To define clinical and biological characteristics of patients not responding to crizotinib therapy at the first tumor assessment versus individuals with complete or deep partial response (\> 50% reduction in the sum of target lesions) 2. To define additional biomarkers selectively present in the ALK positive population 3. To explore outcome of individuals with brain metastases 4. To define timing of local ablative therapy in presence of brain metastas
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Males and Females aged 18 years with diagnosis of advanced or metastatic NSCLC * 2\. Former participation in the Italian NPU program between December 2010 - April 2013 or receiving crizotinib according to 648 legislative Decrete from April 2013 to February 2015 and thereafter in clinical practice up to December 31st, 2017. * 3\. Ascertained compliance to the Crizotinib therapy as prescribed by the relevant physician * 4\. ALK rearrangement report including details of method and cutoff used for ALK testing * 5\. Data on prior therapies * 6\. Data on toxicity * 7\. Data on crizotinib therapy efficacy including response to the therapy and survival * 8\. Data on site of metastases * 9\. Availability of archival tissue (not mandatory) * 10\. Signed Informed Consent for alive and contactable patients Exclusion Criteria: * 1\. Lack of clinical data * 2\. No evidence of ALK rearrangemement * 3\. Early death defined as fatal outcome within 30 days since the first crizotinib dose * 4\. Absence of any radiological assessment * 5\. No data on crizotinib efficacy including survival
References
Publications (0)
Data not yet available
No reference posted for this study.