Phase II study of Erlotinib for previously treated advanced or recurrent non-small-cell lung cancer with EGFR wild type and KRAS wild type

Phase II study of Erlotinib for previously treated advanced or recurrent non-small-cell lung cancer with EGFR wild type and KRAS wild type - Phase II study of Erlotinib for previously treated advanced or recurrent non-small-cell lung cancer with EGFR wild type and KRAS wild type

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008398

Enrollment

Registered

2012-07-11

Start date

2012-03-01

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

advanced or recurrent non-small-cell lung cancer

Interventions

Erlotinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-squamous non small cell lung cancer 2)Patients with EGFR wild type and KRAS wild type 3)Patients with Stage3B/4 4)Patients who have previously treated with one or two chemotherapy 5)Patients who has measurable by RECIST criteria 6)Patients aged 20 years or older 7)ECOG Performance status 0-2 8)Adequate organ function 9)Life expectancy more than 3 months 10)Signed 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)Cases with past history of administration of HER related agents 3)4) Patients having EGFR mutation (exon 18,19,20,21) 4)Patients with gastrointestinal disorders 5)Patients with active opthalmological disease 6)Patients with spinal cord compression syndrome 7)Patients with symptomatic brain 8)Patients with active severe infections 9)Patients with active cardiac disease 10)Patients with severe clinical symptom 11)Patients active concomitant malignancy 12)Severe psychological disease 13)Pregnant or breast-feeding females or those who declined contraception 14)Inappropriate patients for this study judged by the attending physician

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Response Rate Overall survival Safety	—

Countries

Japan

Outcome results

None listed

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