NCT03874000 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Afzal MZ, Mercado RR, Shirai K
Efficacy of metformin in combination with immune checkpoint inhibitors (anti-PD-1/anti-CTLA-4) in metastatic malignant melanoma. J Immunother Cancer. 2018 Jul 2;6(1):64. doi: 10.1186/s40425-018-0375-1.
Kubo T, Ninomiya T, Hotta K, Kozuki T, Toyooka S, Okada H, Fujiwara T, Udono H, Kiura K
Study Protocol: Phase-Ib Trial of Nivolumab Combined With Metformin for Refractory/Recurrent Solid Tumors. Clin Lung Cancer. 2018 Nov;19(6):e861-e864. doi: 10.1016/j.

An Open-Label Single-Arm Phase Ⅱ Study to Evaluate Efficacy and Safety of Sintilimab Combined With Metformin Hydrochloride in Patients With Advanced Non-small Cell Lung Cancer Refractory to First-Line Treatment

Details for clinical trial NCT03874000

Clinical trial NCT03874000 - References