Summary
Mitomycin 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8 registered trials linking Mitomycin to Lung Cancer: 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00003159). It plans or enrolled 600 participants. Registration activity spans 1997 to 2023. The literature layer holds 11 publications for this pair: 2 Cochrane reviews, 3 meta-analyses, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 1996 to 2022. 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 | 76.0 (trials 26.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 4 completed, 3 other |
| Linked publications | 11 (5 clinical trial publications, 3 meta-analyses, 2 Cochrane reviews, 1 randomised controlled trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00148395 | Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy. 2002 | completed | Phase 3 | 280 |
| NCT00003159 | Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer 1997 | completed | Phase 3 | 600 |
| NCT00004209 | Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer 1998 | status unknown | Phase 3 | — |
| NCT00128037 | Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806) 1999 | completed | Phase 2 | 75 |
| NCT05672108 | Phase II Trial of Lung Chemoemobolization 2023 | recruiting | Phase 2 | 30 |
| NCT00024271 | Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer 2001 | status unknown | Phase 2 | — |
| NCT01953406 | The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma 2015 | withdrawn | Phase 2 | — |
| NCT04200417 | Chemoembolization for Lung Tumors 2019 | completed | Phase 1 | 10 |
Published literature
- Cochrane review A network meta-analysis for efficacies and toxicities of different concurrent chemoradiotherapy regimens in the treatment of locally advanced non-small cell lung cancerZheng Q, Min S, Zhou Y · BMC cancer · 2022 · PMID 35725420
- Clinical trial publication Effect of Second-generation vs Third-generation Chemotherapy Regimens With Thoracic Radiotherapy on Unresectable Stage III Non-Small-Cell Lung Cancer: 10-Year Follow-up of a WJTOG0105 Phase 3 Randomized Clinical TrialZenke Y, Tsuboi M, Chiba Y et al. · JAMA oncology · 2021 · PMID 33734289
- Clinical trial publication Veliparib Alone or in Combination with Mitomycin C in Patients with Solid Tumors With Functional Deficiency in Homologous Recombination RepairVillalona-Calero MA, Duan W, Zhao W et al. · Journal of the National Cancer Institute · 2016 · PMID 26848151
- Clinical trial publication Benefits and adverse events among elderly patients receiving concurrent chemoradiotherapy for locally advanced non-small cell lung cancer: analysis of the Okayama Lung Cancer Study Group trial 0007Takigawa N, Kiura K, Segawa Y et al. · Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2011 · PMID 21415777
- Clinical trial publication Phase III study comparing second- and third-generation regimens with concurrent thoracic radiotherapy in patients with unresectable stage III non-small-cell lung cancer: West Japan Thoracic Oncology Group WJTOG0105Yamamoto N, Nakagawa K, Nishimura Y et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · PMID 20625120
- Clinical trial publication Phase III trial comparing docetaxel and cisplatin combination chemotherapy with mitomycin, vindesine, and cisplatin combination chemotherapy with concurrent thoracic radiotherapy in locally advanced non-small-cell lung cancer: OLCSG 0007Segawa Y, Kiura K, Takigawa N et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · PMID 20530281
- Cochrane review [Kanglaite for Treating Advanced Non-small-cell Lung Cancer: A Systematic Review.]Zhu L, Yang Z, Wang S et al. · Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2009 · PMID 20716423
- Randomized controlled trial Haishengsu as an adjunct therapy to conventional chemotherapy in patients with non-small cell lung cancer: a pilot randomized and placebo-controlled clinical trialLi GY, Yu XM, Zhang HW et al. · Complementary therapies in medicine · 2009 · PMID 19114229
- Meta-analysis The role of mitomycin in the treatment of non-small cell lung cancer: a systematic review with meta-analysis of the literatureSculier JP, Ghisdal L, Berghmans T et al. · British journal of cancer · 2001 · PMID 11336463
- Meta-analysis The use of gemcitabine in non-small-cell lung cancer. Provincial Lung Cancer Disease Site Group. Provincial Systemic Treatment Disease Site GroupEvans WK, Kocha W, Gagliardi A et al. · Cancer prevention & control : CPC = Prevention & controle en cancerologie : PCC · 1999 · PMID 10474757
- Meta-analysis The cost-effectiveness of four cisplatin-containing chemotherapy regimens in the treatment of stages III B and IV non-small cell lung cancer: an Italian perspectivePalmer AJ, Brandt A · Monaldi archives for chest disease = Archivio Monaldi per le malattie del torace · 1996 · PMID 8909011
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 Mitomycin approved for Lung Cancer?
Mitomycin 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 Mitomycin in clinical trials for Lung Cancer?
ClinicalTrials.gov lists 8 registered trials linking Mitomycin to Lung Cancer: 1 is currently recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00003159). It plans or enrolled 600 participants. Registration activity spans 1997 to 2023.
What does the evidence show for Mitomycin in Lung Cancer?
Mitomycin 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.