A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)

A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605) - A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000828

Enrollment

180

Registered

2007-09-20

Start date

2007-09-01

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

Sensitive relpased small-cell lung cancer

Interventions

A: nogitecan (1.0 mg/m2/day) on days 1 through 5 every 3 weeks, for 4 courses B: irinotecan, cisplatin and etoposide (PEI) 1 course (2 weeks) consisted of cisplatin (25 mg/m2, day1, 8), etoposide (60

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) histologically or cytologically confirmed small-cell lung cancer 2) received first-line chemotherapy or chemoradiotherapy with platinum-based regimen 3) underwent no operation of small-cell lung cancer 4) relapsed more than 90 days after the completion of first-line treatment 5) pathologically confirmed local relapse of small-cell lung cancer, if it was difficult to distinguish from radiation pneumonitis 6) responded to first-line chemotherapy or chemoradiotherapy (CR or PR) 7) performance status of 0-2 on the Eastern Cooperative Oncology Group scale 8) age from 20 to 75 years 9) unnecessary to have measurable disease 10) adequate organ function (1) WBC >= 3,000 /mm3 (2) Neutrophil >= 1,500 /mm3 (3) Hemoglobin >= 9.0 g/dL (4) Platelet >= 100,000 /mm3 (5) Total serum bilirubin <= 2.0 mg/dL (6) GOT (AST) <= 100 IU/L (7) GPT (ALT) <= 100 IU/L (8) Serum creatinine <= 1.5 mg/dL (9) PaO2 >= 70 torr 11) written informed consent

Exclusion criteria

Exclusion criteria: 1) no active concomitant malignancy 2) pregnancy or lactation 3) serious psychiatric illness 4) steroid treatment 5) massive pleural or pericardial effusion 6) symptomatic brain metastasis 7) interstitial pneumonia or severe pulmonary emphysema 8) diarrhea 9) ileus 10) myocardial infarction within 6 months or unstable angina 11) uncontrollable hypertension 12) uncontrollable diabetes mellitus 13) active infection

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
progression-free survival, adverse events, response rate	—

Countries

Japan

Contacts

Public ContactKoichi Goto

JCOG0605 Coordinating Office National Cancer Center Hospital East, Thoracic Oncology Division

JCOG_sir@ml.jcog.jp04-7133-1111

Outcome results

None listed

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