Phase II study of Erlotinib monotherapy in EGFR mutation-negative lung adenocarcinoma excluded biomarkers against EGFR-TKI treatment.

Phase 2

Recruiting

• Conditions: lung adenocarcinoma

• Registration Number: JPRN-UMIN000011411
• Lead Sponsor: Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL Department of Respiratory Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, or drug-induced pneumonitis 2) Patients with activating EGFR mutation or EML4-ALK fusion gene or K-Ras mutation or MET protein over expression 3) Patients with no history of chemotherapy for lung cancer 4) Patients with uncontrolled ascites, pleural effusion, or pericardial effusion 5) Patients with active severe infections 6) Patients with past history of administration of HER related agents 7) Impossible cases with oral administration 8) Patients with active ophthalmological disease 9) Pregnancy, breast feeding and suspected pregnancy 10) Patients with symptomatic brain metastasis 11) Patients with double cancer 12) Patients with uncontrollable diabetes mellitus 13) Patients with uncontrollable complications 14) Inappropriate patients for this study judged by the physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)

Secondary Outcome Measures

Name	Time	Method
Response Rate (RR), Overall Survival (OS), Safety, Quality of life (QOL)