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Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC

NCT03994744 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2019-08-28

No results posted yet for this study

Summary

In this Single arm study, histologically or cytologically confirmed ED-stage small cell lung cancer (SCLC) patients resistant to or relapsed after standard chemotherapy will be enrolled to investigate the Efficacy and Safety of a Combination of Sintilimab and Metformin.

Primary outcome:

Objective response rate (ORR), Safety of the combination therapy

Secondary outcome:

Overall survival (OS), Progression-free survival (PFS), Duration of response(DOR),

Conditions

  • Small-cell Lung Cancer
  • Small Cell Lung Carcinoma
  • Small Cell Lung Cancer Recurrent
  • Small Cell Lung Cancer Extensive Stage

Interventions

DRUG

PD-1 inhibitor

Intravenous administration of Sintilimab (1200mg/3weeks)

DRUG

Metformin

Metformin treatment will be given (day20) 1 week before the second administration of Sintilimab at a dose of 2000 mg daily (1000mg BID). To reduce GI toxicity, participants start Metformin at 1000 mg daily (500mg am, 500 mg pm) for 1 week.

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Innovent Biologics (Suzhou) Co. Ltd.

    collaborator INDUSTRY

  • Hunan Cancer Hospital

    lead OTHER

Principal Investigators

  • Lin Wu · Hunan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2021-08-01
Completion
2022-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994744 on ClinicalTrials.gov