Sintilimab Combined With Metformin in First-Line Chemotherapy Refractory Advanced NSCLC Patients (SMART)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03874000|
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Biological: Sintilimab Drug: Metformin Hydrochloride||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 8, 2019|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||June 5, 2022|
Experimental: Sintilimab plus Metformin Hydrochloride
Patients receive metformin hydrochloride 500mg orally (PO) twice daily (BID). Patients also receive Sintilimab 200mg intravenously (IV) in 60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression, unacceptable toxicity, or withdrawal of consent.
Other Name: IBI308
Drug: Metformin Hydrochloride
Other Name: Glucophage
- Objective Response Rate (ORR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]ORR is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
- Overall Survival (OS) [ Time Frame: From enrollment until death (up to 24 months) ]OS is defined as time from date of enrollment to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.
- Progress free survival (PFS） [ Time Frame: each 42 days up to PD or death (up to 24 months) ]The PFS time is defined as time from enrollment to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of : "death", "last tumor assessment", "last follow up date" or "last date in drug log"
- Disease Control Rate (DCR） [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]DCR is defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).
- Duration of Response (DOR) [ Time Frame: From the first response date to PD or death (up to 24 months) ]For participants with response (CR or PR), the duration of response: the time from the first response date to disease progression or death, and the date of the final imaging evaluation was deleted for participants without PD or death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874000
|Contact: Dingzhi Huang, M.D.||+86 firstname.lastname@example.org|
|Tianjin Medical University Cancer Institute and Hospital||Recruiting|
|Tianjin, Tianjin, China, 300060|
|Contact: Dingzhi Huang, M.D. +86-22-23340123-3224 email@example.com|
|Principal Investigator: Dingzhi Huang, M.D.|
|Principal Investigator:||Dingzhi Huang, M.D.||Tianjin Medical University Cancer Institute and Hospital|