Clinical trial · Interventional
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amrubicin Hydrochloride | Drug | Amrubicin | ALIAS |
| Etoposide-Cisplatin combined chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Amrubicin Hydrochloride-Cisplatin combined chemotherapy
- interventionNames
- Drug: Amrubicin Hydrochloride
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Etoposide-Cisplatin combined chemotherapy
- interventionNames
- Drug: Etoposide-Cisplatin combined chemotherapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 1.5 years after last subject enrolled
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically/cytologically proven small cell lung cancer * Extensive disease * No prior chemotherapy regimen * Age 18 years or older * ECOG performance status of 0-1 Exclusion Criteria: * Brain metastasis requiring treatment * Treatment (Surgical or radiotherapy)of primary tumor * Interstitial pneumonia or pulmonary fibrosis * Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
References
Publications (1)
- DERIVEDSun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6. PMID 27061082