Phase II study of RG1415(erlotinib hydrochloride) for NSCLC patients with EGFR mutations

Phase II study of RG1415(erlotinib hydrochloride) as first-line treatment for non-small cell lung cancer(NSCLC) patients with epidermal growth factor receptor (EGFR) mutations

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221052

Enrollment

100

Registered

2010-03-31

Start date

2010-03-31

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 with EGER mutation (1st line therapy)

Interventions

investigational material(s) Generic name etc : Erlotinib hydrochloride INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investiga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Histologically or cytologically documented EGFR mutation positive NSCLC. -Stage III, IV or recurrent NSCLC (Chemo naive patient). -Having Measurable lesions by RECIST (Ver.1.0) -ECOG PS 0-1 -Adequate organ function -Informed consent

Exclusion criteria

Exclusion criteria: -Co-existence or history of interstitial lung disease clearly detected by imaging. -Symptomatic brain metastases. -Presence of gastrointestinal disorder meeting following criteria. The disorder renders oral drug administration impossible. The disorder necessitates intravenous nutrition. Abnormalities of gastrointestinal absorption resulting from surgery such as partial resection. -Having intestinal diverticulitis. -Having severe ophthalmological abnormalities.

Design outcomes

Primary

Measure	Time frame
Progression free survival(PFS), safety According to RECIST ver1.0 (PFS) and NCI-CTC ver4.0 (Safety)	—

Secondary

Measure	Time frame
Response rate, Disease control rate, Overall survival(OS), Duration of response and PK profile According to RECIST ver1.0	—

Outcome results

None listed

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