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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011411

Enrollment

Registered

2013-08-07

Start date

2013-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung adenocarcinoma

Interventions

Erlotinib 150mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven stage IIIB, IV or relapsed lung adenocarcinoma. 2) Tumor specimen is available for biomarker analysis 3) Patients without activating EGFR mutation, EML4-ALK fusion gene, K-Ras mutation and MET protein over expression 4) Patients who have previously treated chemotherapy 5) Measurable region evaluable according to the RECIST 6) ECOG performance status of 0-1 7) Expected to be observed for at least 2 weeks in a hospital or in a comparable institution after the initiation of erlotinib treatment 8) Patients aged 20 years or older 9) Sufficient function of main organ 10) Patients who are considered to survive for more than 3 months 11) Written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS)	—

Secondary

Measure	Time frame
Response Rate (RR), Overall Survival (OS), Safety, Quality of life (QOL)	—

Countries

Japan

Contacts

Public ContactHIsashi Takaya

Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL Department of Respiratory Medicine

hisashi5240@yahoo.co.jp03-3588-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026