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Phase I/II study of Amrubicin with Cisplatin in patients with advanced Non-small cell lung cancer

Phase I/II study of Amrubicin with Cisplatin in patients with advanced Non-small cell lung cancer

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080221989
Enrollment
46
Registered
2012-12-19
Start date
2012-12-19
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

Advanced Non-small cell lung cancer

Interventions

investigational material(s) Generic name etc : Amrubicin hydrochloride, Cisplatin INN of investigational material : Therapeutic category code : 423 Antitumor antibiotics and preparations Dosage and A
30-35 mg/m2 IV bolus, day 1,2,3. Cisplatin
60 mg/m2 IV, day 1.

Sponsors

Dainippon Sumitomo Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with advanced non-small cell lung cancer who satisfy the following inclusion criteria -No prior chemotherapy -Performance status of 0-1 etc.

Exclusion criteria

Exclusion criteria: -Prior radiotherapy for primary lesion -Pneumonitis and/or pulmonary fibrosis -Active concomitant malignancy etc.

Design outcomes

Primary

MeasureTime frame
Efficacy Overall response rate—

Secondary

MeasureTime frame
Efficacy, Safety Overall survival, Adverse Events, Adverse Reactive Reactions—

Outcome results

None listed

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