Summary
Bleomycin 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 4 registered trials linking Bleomycin to Lung Cancer: 1 is currently recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00132613). The largest enrolment is 300 participants (NCT01660399). Registration activity spans 1999 to 2021. The literature layer holds 13 publications for this pair: 4 meta-analyses, 1 systematic review, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 1997 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
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 | 62.0 (trials 12.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 1 recruiting, 0 active / not yet recruiting, 2 completed, 1 other |
| Linked publications | 13 (5 clinical trial publications, 4 meta-analyses, 3 randomised controlled trial publications, 1 systematic review) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00132613 | Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion 1999 | completed | Phase 3 | 80 |
| NCT01660399 | Clinical Trial of Boanmycin Hydrochloride With Docetaxel for Patients With Lung Squamous Cell Cancer as Chemotherapy 2012 | status unknown | Phase 2 | 300 |
| NCT00165438 | Pulmonary Function in Patients With Hodgkin's Disease Receiving Bleomycin-Based Chemotherapy 2001 | completed | Not applicable | 60 |
| NCT05427136 | Early Pulmonary Dysfunction in Childhood Cancer Patients 2021 | recruiting | Not applicable | 140 |
Published literature
- Meta-analysis Group I pharmaceuticals of IARC and associated cancer risks: systematic review and meta-analysisLim W, Moon S, Lee NR et al. · Scientific reports · 2024 · PMID 38172159
- Meta-analysis Iodopovidone pleurodesis for malignant pleural effusions: an updated systematic review and meta-analysisMuthu V, Dhooria S, Sehgal IS et al. · Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021 · PMID 33515303
- Clinical trial publication Ablation of soft tissue tumours by long needle variable electrode-geometry electrochemotherapy: final report from a single-arm, single-centre phase-2 studySimioni A, Valpione S, Granziera E et al. · Scientific reports · 2020 · PMID 32042142
- Systematic review Intrapericardial instillation of bleomycin prevents recurrence of malignant pericardial effusions: Series of 46 cases and comprehensive literature reviewLambert A, Salleron J, Kieffer A et al. · Bulletin du cancer · 2020 · PMID 32513434
- Meta-analysis 15q12 variants, sputum gene promoter hypermethylation, and lung cancer risk: a GWAS in smokersLeng S, Liu Y, Weissfeld JL et al. · Journal of the National Cancer Institute · 2015 · PMID 25713168
- Meta-analysis Herbal extract elemene intrathoracic injection in the treatment of lung cancer patients with malignant pleural effusion: a meta-anaylsisChen J, Chen YJ, Wu MD · Journal of cancer research and therapeutics · 2014 · PMID 25207893
- Clinical trial publication Telomerase and telomere length in pulmonary fibrosisLiu T, Ullenbruch M, Young Choi Y et al. · American journal of respiratory cell and molecular biology · 2013 · PMID 23526226
- Clinical trial publication A randomised trial of intrapericardial bleomycin for malignant pericardial effusion with lung cancer (JCOG9811)Kunitoh H, Tamura T, Shibata T et al. · British journal of cancer · 2009 · PMID 19156149
- Clinical trial publication Randomized phase II trial of three intrapleural therapy regimens for the management of malignant pleural effusion in previously untreated non-small cell lung cancer: JCOG 9515Yoshida K, Sugiura T, Takifuji N et al. · Lung cancer (Amsterdam, Netherlands) · 2007 · PMID 17716779
- Clinical trial publication Catheter drainage followed by the instillation of bleomycin to manage malignant pericardial effusion in non-small cell lung cancer: a multi-institutional phase II trialMaruyama R, Yokoyama H, Seto T et al. · Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2007 · PMID 17410012
- Randomized controlled trial Mutagen sensitivity may predict lung protection by amifostine for patients with locally advanced non-small cell lung cancer treated by chemoradiotherapyKomaki R, Chang JY, Wu X et al. · Seminars in oncology · 2005 · PMID 16015542
- Randomized controlled trial [Pleurodesis in malignant pleural effusion: bleomycin vs. mitoxantrone]Schmidt M, Schaarschmidt G, Chemaissani A · Pneumologie (Stuttgart, Germany) · 1997 · PMID 9221383
- Randomized controlled trial [Induction chemotherapy followed by concomitant combined radiotherapy and chemotherapy in stage III non-small cell bronchial carcinoma]Bouillet T, Morère JF, Mazeron JJ et al. · Cancer radiotherapie : journal de la Societe francaise de radiotherapie oncologique · 1997 · PMID 9273182
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 Bleomycin approved for Lung Cancer?
Bleomycin 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 Bleomycin in clinical trials for Lung Cancer?
ClinicalTrials.gov lists 4 registered trials linking Bleomycin to Lung Cancer: 1 is currently recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00132613). The largest enrolment is 300 participants (NCT01660399). Registration activity spans 1999 to 2021.
What does the evidence show for Bleomycin in Lung Cancer?
Bleomycin has both completed registered trials and synthesis-level publications linked to Lung Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. 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.