This study aims to compare the efficacy of afatinib maintenance with pemetrexed maintenance following induction therapy with platinum/ pemetrexed in patients with metastatic epidermal growth factor receptor (EGFR) mutated non-small-cell lung cancer (NSCLC) progressing after first-line treatment with afatinib with respect to progression-free survival.
Description: The primary endpoint of this study is progression-free survival (RECIST 1.1).Measure: Progression-free survival Time: 40 months
Description: Efficacy measureMeasure: Overall survival Time: 40 months
Description: Objective response rate (ORR), clinical benefit rate (RECIST 1.1); Efficacy measureMeasure: Objective response rate Time: 40 months
Description: Health-Related Quality of Life (HRQoL)Measure: Quality of Life Time: 40 month
Description: Safety, toxicity (intensity and incidence of adverse events, graded according to US NCI CTCAE Version 4.03)Measure: Safety (intensity and incidence of adverse events, graded according to US NCI CTCAE Version 4.03) Time: 40 month
There is one SNP
Ability to comply with the protocol for the duration of the study, including hospital/office visits for treatment and scheduled follow-up visits and examinations Exclusion Criteria: 1. Systemic therapy for metastatic disease or relapse other than (a) first-line therapy with afatinib or (b) afatinib given as first EGFR-targeting agent following up to 4 courses of platinum-based chemotherapy with no disease progression between first-line chemotherapy and initiation of afatinib (prior adjuvant chemotherapy is allowed) and 3 to 4 cycles of induction chemotherapy with cisplatin or carboplatin and pemetrexed following afatinib failure 2. Prior treatment with erlotinib, gefitinib or other investigational or approved EGFR-targeting small molecules or antibodies 3. Known EGFR T790M mutation (analysis not mandatory) 4. Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study 5. Extended radiotherapy within 4 weeks prior to randomization, except as follows: 1. Palliative, limited local radiation to non-target lesions (e.g. --- T790M ---