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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.

Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary.

Context: Treatment of Progressive Stage IV, Relapsed, and Recurrent NSCLC / Treatment Options for Progressive Stage IV, Relapsed, and Recurrent NSCLC (Second-Line Therapy) / ALK-directed TKIs / ALK-directed TKIs after prior ALK TKI therapy

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.

Publication references

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Preserved source evidence · Not medical advice