Afatinib and Best Supportive Care vs Placebo and Best Supportive Care in Non-Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib
Phase IIb/III, randomized, double-blind trial of afatinib* plus best supportive care (BSC) vs placebo plus BSC in patients with non-small cell lung cancer after failure of erlotinib or gefitinib.
Trial CT.gov-Identifier: NCT00656136
Stage IIIB/IV adenocarcinoma of the lung
Progressed after one or two lines of chemotherapy (including one platinum-based regimen) and ≥12 weeks of treatment with erlotinib or gefitinib
Eastern Cooperative Oncology Group performance status of 0–2
Primary outcome measure:
Secondary outcome measures:
Median OS was 10.8 months with afatinib and 12.0 months with placebo; the difference was not statistically significant.
CI, confidence interval.
Median PFS was significantly longer with afatinib (3.3 months) than with placebo (1.1 months). Twenty-nine patients (7%) had a confirmed objective response to afatinib by independent review, compared with one partial response in the placebo group.
CI, confidence interval.
The most common adverse events for afatinib were:
In the LUX-Lung 1 trial, afatinib improved PFS and response rate but not OS compared with placebo in patients with advanced lung adenocarcinoma that has progressed after one or two lines of chemotherapy and ≥12 weeks of treatment with either erlotinib and/or gefitinib.
Miller VA, et al. Lancet Oncol 2012;13(5):528–538.
Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT00656136 (Accessed: September 2020).
*Afatinib is approved in more than 80 markets including the EU, Japan, Taiwan, and Canada under the brand name GIOTRIF®, in the US under the brand name GILOTRIF® and in India under the brand name Xovoltib®; for the full list please see here. Registration conditions differ internationally; please refer to locally approved prescribing information.
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Last updated: January 2021
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