Phase II study of erlotinib monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status (OSAKA-LCSG1304)

Phase II study of erlotinib monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status (OSAKA-LCSG1304) - OSAKA-LCSG1304

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011473

Enrollment

Registered

2013-08-27

Start date

2013-08-27

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) 20 years-old or older (2) Histologically or cytologically confirmed non-small cell lung cancer (3) Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery, or recurrence 6 months after postoperative adjuvant chemotherapy (4) With positive EGFR mutation status (deletion of exon 19 or L858R point mutation in exon 21), and without T790M point mutation status in exon 20 (5) ECOG performance status of 3 to 4 (6) Evaluable disease (RECIST ver1.1) (7) No history of EGFR-TKI (8) Adequate organ function, evaluated within 14 days before enrollment as; ALT =or< 100IU/L Total bilirubin =or< 2.0mg/dL (9) Interval; 3 weeks after immunotherapy or hormone therapy, 2 weeks after pleurodesis with anti-tumor agent (10) 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
Overall Survival (OS)	—

Secondary

Measure	Time frame
Progression Free Survival (PFS), Response Rate (RR), Frequency and grade of adverse event, QOL(EORTC QLQ-PAL15)	—

Countries

Japan

Contacts

Public ContactSeigo Minami

Osaka Police Hospital Dept. of Respiratory Medicine

06-6771-6051

Outcome results

None listed

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