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Phase II study of cisplatin, docetaxel, and irinotecan, followed by gefitinib, gemcitabine and vinorelbine for patients with non-small-cell lung cancer harboring active EGFR gene mutations (OLCSG0704)

Phase II study of cisplatin, docetaxel, and irinotecan, followed by gefitinib, gemcitabine and vinorelbine for patients with non-small-cell lung cancer harboring active EGFR gene mutations (OLCSG0704) - CDDP/DOC(/CPT-11), followed by Gefitinib, GEM/VNB for non-small-cell lung cancer patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002095
Enrollment
30
Registered
2009-08-01
Start date
2007-12-01
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

Cisplatin, docetaxel, (and irinotecan), followed by gefitinib, gemcitabine and vinorelbine for patients with non-small-cell lung cancer harboring active EGFR gene mutation

Sponsors

Okayama Lung Cancer Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically and/or cytologically proven NSCLC No prior surgery, chemotherapy, or radiotherapy Age ≤ 65 Stage IIIB (unfit for curative thoracic radiation) or IV ECOG performance status 0 or 1 Measurable disease Ample bone marrow, lung, hepatic, and renal function Signed informed consent

Exclusion criteria

Exclusion criteria: Symptomatic brain metastasis, Symptomatic malignant pleural/pericardial effusion Active concomitant malignancy Unstable angina, recent myocardial infarction, heart failure Uncontrolled diabetes or hypertension Pregnant or lactating women Other severe complications

Design outcomes

Primary

MeasureTime frame
Overall survival—

Secondary

MeasureTime frame
Response rate, progression-free survival, adverse events, treatment compliance, relationship between response rate and expression levels of ERCC1 and thioredoxin in the tumors, Comparison of outcomes with EGFR mutation negative patients—

Countries

Japan

Contacts

Public ContactNagio Takigawa

Okayama Lung Cancer Study Group Office

ntakigaw@md.okayama-u.ac.jp086-235-7227

Outcome results

None listed

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