Summary
Daunorubicin Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lung Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lung Cancer. ClinicalTrials.gov lists 8 registered trials linking Daunorubicin Hydrochloride to Lung Cancer: 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02566993). It plans or enrolled 613 participants. Registration activity spans 1994 to 2019. No published literature item is linked to Daunorubicin Hydrochloride and Lung Cancer in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Lung Cancer ranks 465 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression is rare (<0.5% of cases); 5-year survival without treatment: <5% for advanced NSCLC; ~20% for stage I-II with surgery.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 48.0 (trials 28.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 4 completed, 3 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | BRCA1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00002822 | Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer 1996 | completed | Phase 3 | 400 |
| NCT02566993 | Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer 2016 | completed | Phase 3 | 613 |
| NCT00003034 | ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen 1997 | status unknown | Phase 3 | 300 |
| NCT00011921 | Chemotherapy Followed by Peripheral Stem Cell or Bone Marrow Transplant Compared With Chemotherapy Alone in Treating Patients With Small Cell Lung Cancer 1997 | status unknown | Phase 3 | 430 |
| NCT03678883 | 9-ING-41 in Patients With Advanced Cancers 2019 | active, not recruiting | Phase 2 | 350 |
| NCT00634205 | Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma 2006 | completed | Phase 2 | 45 |
| NCT00002608 | Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors 1994 | completed | Phase 2 | 30 |
| NCT00024271 | Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer 2001 | status unknown | Phase 2 | — |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Daunorubicin Hydrochloride approved for Lung Cancer?
Daunorubicin Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Lung Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Lung Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Daunorubicin Hydrochloride in clinical trials for Lung Cancer?
ClinicalTrials.gov lists 8 registered trials linking Daunorubicin Hydrochloride to Lung Cancer: 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02566993). It plans or enrolled 613 participants. Registration activity spans 1994 to 2019.
What does the evidence show for Daunorubicin Hydrochloride in Lung Cancer?
Daunorubicin Hydrochloride has 4 completed registered trials for Lung Cancer but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.