TriangleHEALTH PROFESSIONAL · SOURCE READING
Erlotinib
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.
Evidence (erlotinib):
An open-label phase III trial (NCT00874419) from China included 165 patients older than 18 years with histologically confirmed stage IIIB/IV NSCLC and confirmed activating EGFR variants (i.e., EGFR exon 19 deletion or EGFR L858R single nucleotide variant). Patients were randomly assigned to receive either oral erlotinib (150 mg/day) until they experienced disease progression or unacceptable toxic effects, or up to four cycles of gemcitabine plus carboplatin.[57]
Source links and citations
An open-label phase III trial (NCT00874419) from China included 165 patients older than 18 years with histologically confirmed stage IIIB/IV NSCLC and confirmed activating EGFR variants (i.e., EGFR exon 19 deletion or EGFR L858R single nucleotide variant). Patients were randomly assigned to receive either oral erlotinib (150 mg/day) until they experienced disease progression or unacceptable toxic effects, or up to four cycles of gemcitabine plus carboplatin.[57]
The median PFS was significantly longer in patients who received erlotinib than in patients who received chemotherapy (13.1 months [95% CI, 10.58–16.53] vs. 4.6 months [range, 4.21–5.42 months]; HR, 0.16; 95% CI, 0.10–0.26; P < .0001).[57][Level of evidence B1]
Source links and citations
In a European study (EURTAC [NCT00446225]), 1,227 patients with advanced NSCLC were screened for EGFR variants. Of these, 174 patients with EGFR variants were randomly assigned to receive erlotinib or platinum-based chemotherapy.[58] The primary end point was PFS.
In a European study (EURTAC [NCT00446225]), 1,227 patients with advanced NSCLC were screened for EGFR variants. Of these, 174 patients with EGFR variants were randomly assigned to receive erlotinib or platinum-based chemotherapy.[58] The primary end point was PFS.
In an interim analysis of the first 153 patients, PFS in the chemotherapy arm was 5.2 months (95% CI, 4.5–5.8) compared with 9.7 months (95% CI, 8.4–12.3) in the erlotinib arm (HR, 0.37; P < .0001). Median survival was 19.3 months in patients in the chemotherapy arm and 19.5 months in patients in the erlotinib arm (HR, 0.80; P = .42).[59][Level of evidence B1]
Source links and citations
Studies cited in this source section
Source citation is not a determination that a study applies to you.
Publication references
Read the original reference and check its publication notices.
Preserved source evidence · Not medical advice