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Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

A Phase II Open-label, Single-arm Study Assessing the Efficacy and Safety of Combination Therapy of Sintilimab and Metformin With Relapsed PD-L1 Positive Small Cell Lung Cancer

NCT03994744•Hunan Cancer Hospital

View on ClinicalTrials.gov

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),

Detailed Description

Exploratory Endpoints: The association between the efficacy of the combination treatment and changes in CTC counts after administration of the treatment. Evaluating the correlation between programmed death ligand 1 (PD-L1) expression derived from circulating tumor cells (CTC) and tumor tissue cells, and the predictive role of CTC PD-L1 expression in ED-SCLC. The compositional changes in the gut microbiota after administration of the treatment and its association with the efficacy of the combination treatment.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female patient, age≥18 and≤65;
•2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
•3. The life expectancy of greater than 12 weeks;
•4. Participants must have histologically or cytologically confirmed metastatic or extended disease of SCLC (ED-SCLC).
•5. According to RECIST1.1, participants must have been confirmed Disease progression (within 6 months, confirmed by imaging test)after platinum-based doublet chemotherapy OR after (PFS\>6 months, ) platinum-based doublet chemotherapy and refused to continue chemotherapy, OR after second-line or more lines of systemic chemotherapy limited disease SCLC (LD-SCLC) patients with disease progression after Synchronous chemoradiotherapy, must receive firstline systematic platinum-based doublet chemotherapy and refused to receive chemotherapy again.
•6. Evaluable or measurable lesion is required, defined as at least one lesion (not brain metastasis) that can be accurately measured based on RECIST 1.1;
•7. Participant need to provided tumor tissue (from an archival tumor sample obtained within 1 year or from a new biopsy sample) for PD-L1 immunohistochemical (IHC) assay, and PD-L1expression in more than 1% cells is required;
•8. Participant is able to the ability to swallow oral medications
•9. Participants have to meet the following criteria to ensure function of vital organs:
•Absolute neutrophil count (ANC) ≥1.5×109/L or White blood cell count \>3.5×109/L;Platelets \>80×109/L; Hemoglobin (HGB)≥90 g/L;Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤2.5 ×ULN; ALB≥2.8g/dL;Serum creatinine ≤ 1.5 x institutional ULN OR creatinine clearance ≥40 mL/min using the Cockcroft-Gault equation
+1 more criteria

Exclusion Criteria

•1. Participants who were diagnosed as mixed pathological type of small cell lung cancer
•2. Participants who had long-term use of metformin (\>2 weeks) 6 months prior to study entry, or diagnosed with type-2 diabetes,
•3. Participants received treatment with anti-PD1, -PDL1, -CTLA4, -CD137 inhibitors before, or any therapy specifically targeting T-cell co-stimulation or checkpoint pathways.
•4. Participants received cellular immunotherapy before
•5. Participants with Uncontrolled intercurrent illness including, but not limited to:
•Ongoing or active infection; Known history of Human Immunodeficiency Virus (HIV) infection Acute or chronic active hepatitis B (HBV DNA \>1\*10\^3 copies/ml or \>200 IU/mL) or, acute or chronic active hepatitis C (with a positive Hepatitis C antibody test result) Active tuberculosis Congestive heart failure (Class III-IV, according to New York Heart Association classification), or and clinically significant Cardiac arrhythmia if poorly controlled; Uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) Any arterial thrombosis, embolism, ischemia, myocardial infarction, unstable angina, or cerebrovascular accident within 6 months prior to enrollment,
•6. Participants with symptomatic Central nervous metastasis or meningeal carcinomatosis are excluded; Participants with asymptomatic brain metastases or with brain metastases that have been treated and stable in a subsequent scan are allowed to include if there is measurable lesion outside the Central nervous system and no history of intracranial hemorrhage, and not midbrain, pons, cerebellum, medulla or spinal cord metastasis, and do not need glucocorticoid therapy.
•7. Participants receiving glucocorticoid (\>30 mg prednisone equivalent a day) or any Immunosuppressive drug within 14 days prior to study recruitment; Participants receiving inhaled or Topical corticosteroids, adrenal corticosteroid replacement therapy (\>10 mg prednisone equivalent a day) are allowed if they have no active autoimmune disease
•8. Participants with a known additional malignancy (Except for Non-melanoma skin cancer and the following in situ carcinoma: in situ bladder carcinoma, in situ gastric carcinoma, in situ colonic carcinoma, in situ endometrial carcinoma, in situ cervical carcinoma /dysplasia, in situ melanoma carcinoma and in situ breast Carcinoma) unless they Maintained Complete Remission for at least 5 years and do not need corresponding treatment during the study
•9. Participants who have not recovered (i.e., ≤ Grade 1 according to NCI CTCAE V4or at baseline) from adverse effects due to a previously administered agent.
+6 more criteria

Locations (1)

Hunan Cancer hospital

Changsha, Hunan, China

Key Dates

Start Date

August 20, 2019

Primary Completion Date

August 1, 2021

Completion Date

July 1, 2022

Last Updated

August 28, 2019

Enrollment

ESTIMATED participants

Conditions

Small-cell Lung CancerSmall Cell Lung CarcinomaSmall Cell Lung Cancer RecurrentSmall Cell Lung Cancer Extensive Stage

Interventions

PD-1 inhibitor

DRUG

Metformin

DRUG

Contacts

Lin Wu, Prof.

CONTACT

+86 13170419973 wulin-calf@vip.163.com

Xingxiang Pu, Prof.

CONTACT

+86 15874180022 pxx_1354@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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