HEALTH PROFESSIONAL · SOURCE READING
Ceritinib
Source: Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 15, 2025 · Captured 2026-09-09.
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Evidence (ceritinib):
A single-arm open-label trial enrolled 163 patients with ALK-translocated stage IIIB/IV NSCLC who had disease progression while receiving crizotinib or were intolerant to the drug.[35] The primary end point was objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) with a secondary end point of DOR.
Source links and citations
A single-arm open-label trial enrolled 163 patients with ALK-translocated stage IIIB/IV NSCLC who had disease progression while receiving crizotinib or were intolerant to the drug.[35] The primary end point was objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) with a secondary end point of DOR.
The objective response rate by blinded independent review was 43.6% (95% CI, 36%–52%), and the median DOR was 7.1 months (range, 5.6–not estimable [NE]).[35][Level of evidence C3]
Source links and citations
A single-arm open-label trial enrolled 163 patients with ALK-translocated stage IIIB/IV NSCLC who had disease progression while receiving crizotinib or were intolerant to the drug.[35] The primary end point was objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) with a secondary end point of DOR.
Of note, 38% of patients required dose modification because of gastrointestinal toxicity; elevation of alanine transaminase to more than five times the upper limit of normal occurred in 27% of patients.
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