Phase II study of erlotinib monotherapy for patients with advanced stage of non-small cell lung cancer, undetectable epidermal growth factor receptor (EGFR) mutations by PNA LNA PCR clamp method, but positive immuno-staining with anti-EGFR mutation-specific antibodies.

Phase II study of erlotinib monotherapy for patients with advanced stage of non-small cell lung cancer, undetectable epidermal growth factor receptor (EGFR) mutations by PNA LNA PCR clamp method, but positive immuno-staining with anti-EGFR mutation-specific antibodies. - OPH-RM/P-LC-1401

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014299

Enrollment

Registered

2014-07-01

Start date

2014-07-01

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

Erlotinib monotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically or cytologically confirmed non-small cell lung cancer (2) 20 years-old or older (3) Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery (4) No active EGFR mutation was detected by PNA-LNA PCR clamp method, and immunostainning was positive with anti-EGFR mutation-specific antibodies (Ex 19 deletion and Ex21 L858R point mutation). No additional biopsy was expected for sufficient specimen for EGFR mutation re-evaluation. (5) Liquid Based Cytology (ThinPrep) was used for pathological diagnosis and EGFR mutation detections. (6) Recurrence / progressive disease after prior chemotherapy for patients with ECOG PS 0-2. Chemo-na&iuml;ve or recurrence / Progressive disease after prior chemotherapy for patients with ECOG PS 3-4. (7) Evaluable disease (RECIST ver1.1), irrespective of measurable disease (8) No history of EGFR-TKI (9) Adequate organ function, evaluated within 14 days before enrollment as; ALT =or< 100IU/L and total bilirubin =or< 2.0mg/dL (10) Interval; one week after immunotherapy or hormone therapy, 2 weeks after pleurodesis with anti-tumor agent (11) Written informed consent

Exclusion criteria

Exclusion criteria: 1. Problematic infection that requires anti-biotic, anti-fungal agent or anti-viral agent. 2. Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest CT or with clinical symptoms. 3. A history of severe hypersensitivity against erlotinib 4. Difficulty in oral administration of erlotinib, functional / organic impairment or inflammatory bowel disease that disturbs absorption of erlotinib 5. Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer. 6. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 7. Psychologically ineligible 8. Decision of ineligibility by a physician.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival(PFS)	—

Secondary

Measure	Time frame
Response Rate(RR), 1-year survival rate, Overall Survival(OS), Time to treatment failure:TTF, Toxicities	—

Countries

Japan

Contacts

Public ContactSeigo Minami

Osaka Police Hospital Dept. of Respiratory Medicine

seigominami@oph.gr.jp06-6771-6051

Outcome results

None listed

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