Disease × agent evidence record

Nicotine for Lung Cancer: evidence, trials and status

Nicotine 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 19 publications Evidence tier A · Strong Score 74.0
Research Tracker › Pairs › Lung Cancer › Nicotine
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

Nicotine 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 Nicotine to Lung Cancer: 1 is active or not yet recruiting; 7 have completed. The most advanced is Phase 3 (NCT03200236). It plans or enrolled 1114 participants. Registration activity spans 2002 to 2026. The literature layer holds 19 publications for this pair: 5 Cochrane reviews, 5 meta-analyses, 4 systematic reviews and 5 clinical trial publications. Publication years run from 2015 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 & interventionsChEMBLOpen Targets

Evidence table

Evidence tierA · Strong
Evidence score74.0 (trials 24.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 0 recruiting, 1 active / not yet recruiting, 7 completed, 0 other
Linked publications19 (5 Cochrane reviews, 5 meta-analyses, 5 clinical trial publications, 4 systematic reviews)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesOpen Targets, ChEMBL
Linked via biomarker / targetALK
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
NCT03200236The Lung Screening, Tobacco and Health Project
2017
completedPhase 31,114
NCT04616768PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers
2020
completedPhase 3108
NCT01434342Feasibility of Delivering a Quitline Based Smoking Cessation Intervention in Cancer Patients
2011
completedEarly Phase 1146
NCT00310141Computer-Assisted Counseling in Helping African American Smokers Stop Smoking
2002
completedNot applicable462
NCT00957424Acceptability of Less Harmful Alternatives to Cigarettes
2009
completedNot applicable67
NCT02658032Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
2016
completedNot applicable276
NCT01176383Impact of a Gene Test for Susceptibility to Lung Cancer in Smokers
2011
completedNot applicable67
NCT07111936Evaluating the Impact of CONNECT in a Multilingual Population
2026
not yet recruitingNot applicable439

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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 Open Targets and ChEMBL, in this case via the biomarker or target ALK. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Nicotine approved for Lung Cancer?

Nicotine 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 Nicotine in clinical trials for Lung Cancer?

ClinicalTrials.gov lists 8 registered trials linking Nicotine to Lung Cancer: 1 is active or not yet recruiting; 7 have completed. The most advanced is Phase 3 (NCT03200236). It plans or enrolled 1114 participants. Registration activity spans 2002 to 2026.

What does the evidence show for Nicotine in Lung Cancer?

Nicotine 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 Open Targets and ChEMBL, in this case via the biomarker or target ALK. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

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