Clinical trial · Observational
Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
NCT02727335CI-TRIAL-00066667CLINALKcompletedClinicalTrials.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)
Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Lymphoma Kinase Gene Mutation | — | UNRESOLVED | — |
| 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 (1)
- label
- patients ALK + who received crizotinib
- description
- patients with ALK rearrangement who started treatment with crizotinib (250 mg twice a day) between the 18/11/2010 and the 31/12/2013 (will include patients from the ATU programs and patients treated after the marketing of crizotinib)
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 5 years
- description
- overall survival post-progression on crizotinib
Secondary outcomes (1)
- measure
- rare and severe complications of crizotinib therapy
- timeFrame
- 5 years
- description
- Incidence of rare and severe complications of crizotinib therapy: hepatotoxicity, interstitial pneumonitis, diastolic heart failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have locally advanced or metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK determined by IHC and/or FISH. * Patient who received crizotinib on an expanded access basis (compassionate use) (ATU) due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable * Patient who received marketed crizotinib as a result of the standard care of metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK will also be eligible. * Patient was able to swallow capsules and had no surgical or anatomical condition that precluded the patient from swallowing and absorbing oral medications on an ongoing basis. * Patient has taken at least 1 week of treatment Exclusion Criteria: * Patient included in a crizotinib clinical trial * Patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
References
Publications (1)
- RESULTDuruisseaux M, Besse B, Cadranel J, Perol M, Mennecier B, Bigay-Game L, Descourt R, Dansin E, Audigier-Valette C, Moreau L, Hureaux J, Veillon R, Otto J, Madroszyk-Flandin A, Cortot A, Guichard F, Boudou-Rouquette P, Langlais A, Missy P, Morin F, Moro-Sibilot D. Overall survival with crizotinib and next-generation ALK inhibitors in ALK-positive non-small-cell lung cancer (IFCT-1302 CLINALK): a French nationwide cohort retrospective study. Oncotarget. 2017 Mar 28;8(13):21903-21917. doi: 10.18632/oncotarget.15746. PMID 28423535