NCT03874000

Sintilimab Combined With Metformin in First-Line Chemotherapy Refractory Advanced NSCLC Patients

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the Efficacy and Safety of Sintilimab Combined with Metformin Hydrochloride in Patients with Advanced Non-small Cell Lung Cancer Refractory to First-Line Platinum-Containing Chemotherapy

Detailed description

This study is an open-label, single-arm, phase II clinical study on the efficacy and safety of Sintilimab combined with metformin in the treatment of locally advanced, recurrent or metastatic NSCLC patients who fail to receive first-line platinum-containing chemotherapy in patients with locally advanced, recurrent or metastatic non-small-cell lung cancer in China. Simon two stages optimal design criteria are used in the test, and 18 subjects are enrolled in the first stage, and if two or more patients reach the PR/CR evaluation criteria, the sample size will be increased to 43. If 7 or more of the 43 subjects meets the PR/CR evaluation criteria, it indicates that the test achieves the expected results. After the subject signs the informed consent, the subject will receive the treatment of 200 mg IV Q3W (3 weeks using a) of Sintilimab combine with 500mg of metformin for oral bid until disease progression, death, toxicity intolerance, withdrawal of the informed consent, initiation of new anti-tumor treatment or termination of treatment for other reasons specified in the program. The longest duration of treatment for Sintilimab is 24 months. The main endpoint of the study is ORR evaluated by the researchers based on RECIST v1.1. RECIST v1.1 is used for clinical tumor imaging evaluation. Based on the clinical conditions of the patients, it is used every 2 cycles (±7 days) until disease progression, initiation of new anti-tumor therapy, withdrawal of Inform Consent Form (ICF) or death of the subjects. For the first time, if the clinical status of the subjects with disease progression is stable, those who meet the criteria determined by the investigator can continue to receive treatment of Sintilimab combined with metformin, and must undergo imaging evaluation after 4 weeks (± 7 days) to confirm the disease progression. Patients with disease progression will enter the survival follow-up stage (every 60 ± 7 days); Patients who stop treatment due to other causes other than disease progression will continue to receive the tumor assessment every 6 weeks (± 7 days) until the next event (initiation of new anti-tumor treatment, disease progression, withdrawal of ICF or death), and then enter the survival follow-up stage (every 60 ± 7 days). The investigator will evaluate and manage the adverse reactions during the treatment period and within 30 ± 7 days after the last use of the study drug in accordance with the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 and immune-related adverse reactions standard Immune-Related Response Criteria (irRC), evaluation and management of severe adverse reactions during the treatment period and 90 ± 7 days after the last use of the study drug (unless patients start new anti-tumor treatment 31 to 90 days after the last use of the study drug).

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Sintilimab	Given IV
DRUG	Metformin Hydrochloride	Given PO

Timeline

• Start date: 2019-03-08
• Primary completion: 2022-02-28
• Completion: 2022-06-05
• First posted: 2019-03-14
• Last updated: 2019-03-19

Locations

1 site across 1 country: China