NCT04931017

Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer

Active, enrolled Phase 2 Last updated 7 October 2025

What this trial tests

Phase 2 trial testing Biopsy in Lung Carcinoma in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 September 2022

Primary endpoint
31 December 2026

30 June 2027

Quick facts

Lead sponsor	Northwestern University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	50
Start date	9 September 2022
Primary completion	31 December 2026
Estimated completion	30 June 2027
Sites	4 locations across Canada, United States

Drugs / interventions tested

• Biopsy — full drug profile →
• Biospecimen Collection — full drug profile →
• Bronchoscopy
• Extended Release Metformin Hydrochloride
• Questionnaire Administration

Conditions studied

• Lung Carcinoma — all drugs for Lung Carcinoma →

Sponsor

Northwestern University

Who can join

30 and older, any sex, with Lung Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial determines the effect of metformin extended release on the risk for developing lung cancer in overweight/obese patients that are at high-risk for developing lung cancer. Metformin is widely used to treat type II diabetes and has a long history of safety and minimal side effects. At similar dosage, the drug may have potential anti-cancer activity. Metformin use has been associated with improved survival in patients with non-small cell lung carcinoma, a specific type of lung cancer, and it has also been shown to enhance immune mobilization against tumors. This trial aims to see whether metformin extended release as a preventative treatment may lower the chance of developing lung cancer, and whether it may help patients' immune system learn ("reprogram") to lower a certain type of immune cell (called regulatory T cells) that are linked to tumor development.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Obesity and Cancer: A Current Overview of Epidemiology, Pathogenesis, Outcomes, and Management.
   Pati S, Irfan W, Jameel A, Ahmed S, et al · · 2023 · cited 393× · PMID 36672434 · DOI 10.3390/cancers15020485
2. Tumor initiation and early tumorigenesis: molecular mechanisms and interventional targets.
   Zhang S, Xiao X, Yi Y, Wang X, et al · · 2024 · cited 192× · PMID 38890350 · DOI 10.1038/s41392-024-01848-7
3. Advances in metformin‑based metabolic therapy for non‑small cell lung cancer (Review).
   Chen N, Zhou YS, Wang LC, Huang JB. · · 2022 · cited 18× · PMID 35039878 · DOI 10.3892/or.2022.8266
4. Research progress on the therapeutic effect and mechanism of metformin for lung cancer (Review).
   Han P, Zhou J, Xiang J, Liu Q, et al · · 2023 · cited 13× · PMID 36367180 · DOI 10.3892/or.2022.8440
5. Immunometabolism Modulation in Therapy.
   Monferrer E, Sanegre S, Vieco-Martí I, López-Carrasco A, et al · · 2021 · cited 10× · PMID 34356862 · DOI 10.3390/biomedicines9070798
6. The Past and Future of Inflammation as a Target to Cancer Prevention.
   Antonucci L, Karin M. · · 2024 · cited 9× · PMID 38271694 · DOI 10.1158/1940-6207.capr-23-0423
7. Metformin as a promising target for DPP4 expression: computational modeling and experimental validation.
   El-Arabey AA, Zhang H, Abdalla M, Al-Shouli ST, et al · · 2023 · cited 8× · PMID 37624423 · DOI 10.1007/s12032-023-02140-4
8. Randomized Study of Metformin and Intensive Lifestyle Intervention on Cancer Incidence over 21 Years of Follow-up in the Diabetes Prevention Program.
   Heckman-Stoddard BM, Crandall JP, Edelstein SL, Prorok PC, et al · · 2025 · cited 4× · PMID 40243198 · DOI 10.1158/1940-6207.capr-23-0461