Summary
Doxorubicin 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lists 8 registered trials linking Doxorubicin Hydrochloride to Lung Cancer: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00011921). It plans or enrolled 430 participants. Registration activity spans 1994 to 2019. The literature layer holds 5 publications for this pair: 5 clinical trial publications. Publication years run from 1982 to 2003. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 54.0 (trials 24.0, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 4 completed, 4 other |
| Linked publications | 5 (5 clinical trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
| 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 |
| 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 | — |
| NCT03808480 | Nivolumab After Cyclophosphamide and Doxorubicin Induction Therapy in NSCLC With PD-L1<10% 2019 | status unknown | Phase 2 | 22 |
| NCT00041808 | Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver 2001 | completed | PHASE1, PHASE2 | 20 |
Published literature
- Clinical trial publication A phase I study of pegylated liposomal doxorubicin hydrochloride (Caelyx) in combination with cyclophosphamide and vincristine as second-line treatment of patients with small-cell lung cancerLeighl NB, Burkes RL, Dancey JE et al. · Clinical lung cancer · 2003 · PMID 14596693
- Clinical trial publication A pilot phase 2 study of surgical treatment after induction chemotherapy for resectable stage I to IIIA small cell lung cancerFujimori K, Yokoyama A, Kurita Y et al. · Chest · 1997 · PMID 9106591
- Clinical trial publication Chromatographic analysis and pharmacokinetics of liposome-encapsulated doxorubicin in non-small-cell lung cancer patientsEmbree L, Gelmon KA, Lohr A et al. · Journal of pharmaceutical sciences · 1993 · PMID 8392545
- Clinical trial publication Effect of alternating combination chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, cisplatin, and etoposide for small cell lung cancer on hematopoietic progenitors in the peripheral bloodShimizu E, Yamamoto A, Takahashi Y et al. · British journal of cancer · 1993 · PMID 8385979
- Clinical trial publication Levamisole as an adjuvant to chemotherapy in extensive bronchogenic carcinoma: a Veterans Administration Lung Cancer Group StudyDavis S, Mietlowski W, Rohwedder JJ et al. · Cancer · 1982 · PMID 7046908
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 Doxorubicin Hydrochloride approved for Lung Cancer?
Doxorubicin 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 Doxorubicin Hydrochloride in clinical trials for Lung Cancer?
ClinicalTrials.gov lists 8 registered trials linking Doxorubicin Hydrochloride to Lung Cancer: 4 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00011921). It plans or enrolled 430 participants. Registration activity spans 1994 to 2019.
What does the evidence show for Doxorubicin Hydrochloride in Lung Cancer?
Doxorubicin Hydrochloride has 4 completed trials and 5 linked publications for Lung Cancer. Completed trials may or may not have posted results; follow the NCT links to check. 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.