We conducted a phase 3, open-label trial comparing crizotinib with chemotherapy in 347 patients with locally advanced or metastatic ALK-positive lung cancer....The median progression-free survival was 7.7 months in the crizotinib group and 3.0 months in the chemotherapy group (hazard ratio for progression or death with crizotinib, 0.49; 95% confidence interval [CI], 0.37 to 0.64; P<0.001). The response rates were 65% (95% CI, 58 to 72) with crizotinib, as compared with 20% (95% CI, 14 to 26) with chemotherapy (P<0.001).

...- positive for the ALK fusion gene (test provided by either a central laboratory....

...resulting in echinoderm microtubule associated protein like 4 [EML4]-ALK fusion) as determined by the Vysis Break Point fluorescence in situ hybridization (FISH) assay and defined by an increase in the distance between 5?...

...These samples served as a part of negative sample set for evaluation of IHC test and/or polymerase chain reaction (PCR) to determine ALK fusion events. ...

...- The institution's pre-enrollment biomarker screening at a Clinical Laboratory Improvement Amendments (CLIA) certified lab documents presence of known "sensitive" mutations in epidermal growth factor receptor tyrosine kinase (EGFR TK) domain (exon 19 deletion, L858) and/or EML4-anaplastic lymphoma kinase (ALK) fusion arrangement; either the primary tumor or the metastatic lymph node tissue may be used for testing of mutations...

...harbored ALK fusion gene and took crizotinib 3....

...- positive for the ALK fusion gene (test provided by a central laboratory)...

We enrolled 11patients from January 2019 to December 2022 at the Department of Thoracic Surgery II, Peking University Cancer Hospital & Institute with stage IIB-IIIB ALK-positive NSCLC who received Crizotinib or Alectinib as inductive treatment strategy before surgery....All patients were confirmed clinical stage IIB-IIIB and with ALK fusion mutation. Nine patients received ALK-TKI as initial inductive treatment, among which three (patient 1, 6 and 10) received crizotinib at dose of 250 mg twice daily and six (patient 2, 4, 7, 8, 9 and 11) received alectinib at dose of 600 mg twice daily....According to the radiologic assessment before surgery, nine patients (72.7%) achieved a partial regression (PR), and two patients (patient 2 and 6) remained SD.

A total of 55 patients were included in the study, of which 36 with ALK fusion, and 13 with ROS1 fusion.... the ORR of crizotinib was 53% with a median PFS of 12 months (range: 1–102 months)...confirmed the therapeutic benefit of crizotinib in ALK/ROS-1fusion-positive advanced NSCLC, and also in NSCLC with MET ex14 mutation. Our data showed crizotinib is tolerable and effective, which is comparable with literature report.

The study highlighted and confirmed that treatment with crizotinib led to clinical improvement in PFS among patients with advanced NSCLC with ALK fusion…

The 1-year and 2-year survival rates on crizotinib for v1 were 78.6% and 63% respectively...Patients with v2 variant were found to be prognostically superior to both v1 and v3 variants with a median PFS on crizotinib as 17.7 months, and a 1 year survival rate of 88.9% on crizotinib....Variant group V1 was found to have an overall inferior outcome with higher frequency of brain metastases when compared to V3...

Survival in 30 ALK-positive patients who were given crizotinib in the second-line or third-line setting was significantly longer than in 23 ALK-positive controls given any second-line therapy (median overall survival not reached [95% CI 14 months to not reached] vs 6 months [4–17], 1-year overall survival 70% [95% CI 50–83] vs 44% [23–64], and 2-year overall survival 55% [33–72] vs 12% [2–30]; hazard ratio 0·36, 95% CI 0·17–0·75; p=0·004).