Disease × agent evidence record

Gemcitabine for Lung Cancer: evidence, trials and status

Gemcitabine 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.

8 registered trials 0 recruiting 17 publications Evidence tier A · Strong Score 72.0
Research Tracker › Pairs › Lung Cancer › Gemcitabine
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Gemcitabine 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trials linking Gemcitabine to Lung Cancer: 1 is active or not yet recruiting; 3 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02299765). The largest enrolment is 597 participants (NCT02352948). Registration activity spans 2001 to 2023. The literature layer holds 17 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2020 to 2026. 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.

Open in Repurposing ExplorerLung Cancer hubLung Cancer biomarkers & interventions

Evidence table

Evidence tierA · Strong
Evidence score72.0 (trials 22.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 0 recruiting, 1 active / not yet recruiting, 3 completed, 4 other
Linked publications17 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 3 randomised controlled trial publications, 1 systematic review)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesDGIdb
Linked via biomarker / targetBRCA1
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 IDTitleStatusPhaseEnrolment
NCT02299765Intercalating and Maintenance Gefitinib in Combination With Chemotherapy for Advanced EGFR-mutant NSCLC
2014
terminatedPhase 461
NCT02352948A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
2015
completedPhase 3597
NCT04222972A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
2020
terminatedPhase 3223
NCT05500092An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer
2023
active, not recruitingPhase 217
NCT00024271Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer
2001
status unknownPhase 2—
NCT05867121A Study to Evaluate Safety, Pharmacokinetics, & Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors; Urothelial Carcinoma Substudy in Association With RO7496353 Study GO44010
2023
completedPhase 1102
NCT02797977A Phase 1/2 Trial SRA737 in Combination With Gemcitabine and Cisplatin or Gemcitabine Alone in Advanced Cancer Subjects
2016
completedPHASE1, PHASE2153
NCT02873416Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
2016
status unknownPHASE1, PHASE240

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Published literature

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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 Gemcitabine approved for Lung Cancer?

Gemcitabine 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 Gemcitabine in clinical trials for Lung Cancer?

ClinicalTrials.gov lists 8 registered trials linking Gemcitabine to Lung Cancer: 1 is active or not yet recruiting; 3 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02299765). The largest enrolment is 597 participants (NCT02352948). Registration activity spans 2001 to 2023.

What does the evidence show for Gemcitabine in Lung Cancer?

Gemcitabine 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

Open Source Medicine Foundation. Gemcitabine for Lung Cancer: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/lung-cancer/gemcitabine.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.