A phase II study of Erlotinib as 2nd-line treatment for patients with StageIIIB/IV non-small cell lung cancer

A phase II study of Erlotinib as 2nd-line treatment for patients with StageIIIB/IV non-small cell lung cancer - A phase II study of Erlotinib as 2nd-line treatment for patients with StageIIIB/IV non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006078

Enrollment

Registered

2011-07-30

Start date

2011-07-01

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

non-small cell lung cancer

Interventions

Patients were given Erlotinib(150mg/day) until PD or appearing unacceptable toxity.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)histologically or cytologically confirmed stage IIIB/IV non-squamous non-small-cell lung cancer 2)Patients who have previously treated with conbination therapy of Carboplatin/ Paclitaxel/ Bavacizumab 3)No prior treatment with HER related agents (gefitinib, lapatinib, trastuzumab, cetuximab, etc.). 4)Patient who has at least one or more measurable lesion by RECIST 5)Performance Status(ECOG) 0-2 6)Patients who can be hospitalized for 1-2 weeks after beginning of the treatment or under management to apply to it. 7)Patients aged 20-75 year old 8)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria *Leukocyte counts >= 3,000/mm3 *Neutrophil counts >= 1,500/mm3 *Platelets >= 100,000/mm3 *Hemoglobin concentration >= 9.0 g/dL *AST and ALT, x 2.5 of upper limit of normal (ULN) or less. *Total bilirubin <=1.5mg/dL. *Serum creatinin, x 1.5 of ULN or less. *Electrocardiogram Nomal *SpO2 >=90% or SaPO2 >=65mmHg 9)Patients who are considered to survive for more than 3 months. 10)interval: (1) chemotherapy *More than 4 weeks after the last chemotherapy. *More than 2 weeks after the maintenance chemotherapy. (2) Radiation *More than 12 weeks after the thoracic irradiation or more than 1 weeks after the last irradiation to other organs. (3) Operation (including pleurodesis) *More than 2 weeks after the last operation 11)Patients providing 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 active severe infections 3)Impossible cases with oral administration 4)Patients with active opthalmological disease 5)Pregnancy or lactation 6)Patients with active concomitant malignancy 7)Patients with uncontrollable diabetes mellitus 8)Patients with uncontrollable complications 9)Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression free survival, Adverse events, Overall survival, Response rate of each EGFR status	—

Countries

Japan

Outcome results

None listed

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