Phase 2 trial of the efficacy and safety of Afatinib for EGFR-TKI untreated EGFR gene mutation-Positive Elderly advanced or recurrent non-small cell lung Cancer. (APEC)

Phase 2

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-UMIN000020370
• Lead Sponsor: Saitama Lung Cancer Research Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-27
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with active double cancers (simultaneous double cancers and metachronous double cancers with less than 5 years disease-free interval) Exclusion: carcinoma in situ of cervix, gastric and colorectal cancers which can be radically resected by endoscope, and locally-resectable skin cancer except malignant melanoma 2) Patients with apparent interstitial pneumonia or pulmonary fibrosis on chest computed tomography 3) Patients with symptomatic brain metastases Exclusion: patients who have had stable symptoms more than 2 weeks after radiation therapy or more than 4 weeks after surgery 4) Patients with active infection 5) Patients requring continuous oxgen therapy 6) Patients who are in pregnancy or intend to get pregnant 7) Patients with a history of serious drug allergy 8) Patients with other serious complications 9) Patients with a history of allergy for a component of afatinib 10) Patients who are considered to have difficulty in enrollment of this trial based on clinically important psychiatric reasons 11) Patients who are considered to be inappropriate in enrollment of this trial by attending physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified