Statement: In the primary trial The Percentage of Participants With Objective Response (OR) for the Afatinib Monotherapy was 13% lower than the Afatinib and Paclitaxel or Vinorelbine Combination Therapy group.
Primary_evidence: Outcome Measurement:    Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1   Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.   Time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days Results 1:    Arm/Group Title: Afatinib Monotherapy   Arm/Group Description: Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.   Overall Number of Participants Analyzed: 74   Measure Type: Number   Unit of Measure: Percentage of participants  18        (10 to 28) Results 2:    Arm/Group Title: Afatinib and Paclitaxel or Vinorelbine Combination Therapy   Arm/Group Description: Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy   Overall Number of Participants Analyzed: 39   Measure Type: Number   Unit of Measure: Percentage of participants  31        (17 to 48)