A Randomized, phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small-cell lung cancer HOT1401/NJCLG1401

A Randomized, phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small-cell lung cancer HOT1401/NJCLG1401 - Randomized P2 ED SCLC maintenance CPT vs AMR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013882

Enrollment

Registered

2014-06-10

Start date

2014-07-20

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

chemotherapy-naive extensive disease small-cell lung cancer

Interventions

Patients receive induction therapy of cisplatin plus irinotecan followed by irinotecan maintenance therapy (60mg/m2, day1,8, every 3 weeks). Patients receive induction therapy of cisplatin plus irinot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) non-small-cell lung cancer 2) Chemotherapy-naive 3) Radiotherapy-naive 4) IIIB to IV or postoperative recurrent without indication of resection or radiation. 5) ECOG-PS 0 or 1 or 2 6) Measurable lesion by RECIST ver.1.1 criteria 7) Adequate organ function 8) Life expectancy more than 3 months 9) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Clinically active interstitial pneumonia or pulmonary fibrosis, detectable on CT scan 2) History of heart disorder. 3) Severe co-morbidities (ex. uncontrolled heart or lung or hepatic or renal disease or diabetes) 4) Regular use of corticosteroid (less than 2 weeks interval after cessation) 5) Pregnancy or lactation, or those who decline contraception 6) Contraindication with chemotherapy 7) Active concomitant malignancy. Except carcinoma in situ or those who did not relapse 5-years or more 8) Those judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
progression free survival rate at 6 months	—

Secondary

Measure	Time frame
progression free survival, overall survival,progression free survival of maintenance therapy, adverse events, 1 year survival rate, transition rate to maintenance therapy	—

Countries

Japan

Contacts

Public ContactHisashi Tanaka

Hirosaki University Graduate School of Medicine Cardiology, Respiratory medicine and Nephrology

xyghx335@gmail.com0172-39-5057

Outcome results

None listed

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