Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
Amrubicin + nedaplatin is a chemotherapy combination that has been studied primarily for the treatment of non-small cell lung cancer (NSCLC) and squamous cell lung cancer (SCC). This combination brings together two distinct mechanisms of action to target cancer cells. ### Components and Mechanism The combination consists of: 1. **Amrubicin**: A novel DNA topoisomerase II inhibitor that works by interfering with the DNA replication process in cancer cells[1][5]. Amrubicinol is the active metabolite of amrubicin[5]. 2. **Nedaplatin**: A second-generation platinum compound developed to decrease the nephrotoxicity and gastrointestinal toxic effects induced by cisplatin, while maintaining its anti-tumor properties[1]. It functions as a DNA cross-linking agent. ### Clinical Studies Several clinical trials have evaluated this combination: - A phase I/II study determined that the recommended dosage is nedaplatin 100 mg/m² on day 1 and amrubicin 25 mg/m² on days 1-3, administered intravenously every 3-4 weeks[1][2]. - In a phase II study for treatment-naïve patients with advanced NSCLC, the overall response rate (ORR) was 48.6% (17 out of 35 patients achieved a partial response)[2]. - For squamous cell lung cancer specifically, a phase II study demonstrated efficacy comparable to other conventional chemotherapeutic regimens[1][6]. ### Safety Profile The combination therapy has shown manageable toxicity profiles: - Common adverse events include hematological toxicities such as neutropenia, anemia, and thrombocytopenia[2]. - Febrile neutropenia occurred in 3.9% of treatment cycles but was manageable in all cases[2]. - The combination appears to have reduced gastrointestinal and neuromuscular toxicities compared to some other platinum-based regimens[1]. ### Potential Applications This combination may be particularly valuable for: - Patients with squamous cell lung cancer, where subset analysis suggested higher efficacy (ORR of 70% in SCC vs. 40% in non-SCC)[1]. - Potentially for patients with SCLC refractory to irinotecan and/or cisplatin, as in vitro studies showed that amrubicin in combination with cisplatin or irinotecan was effective against resistant cell lines[5]. The combination of nedaplatin and amrubicin represents a promising treatment approach, particularly for squamous cell lung cancer, with efficacy comparable to conventional regimens but potentially improved toxicity profiles.
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on Amrubicin + Nedaplatin.