Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer

Phase 2

• Conditions: Maintenance; Small Cell Lung Cancer; Extensive Disease; Adoptive Cellular Immunotherapy; Chemotherapy
• Interventions: Drug: sintilimab maintenance

• Registration Number: NCT03983759
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

Small cell lung cancer is a highly aggressive malignancy. Currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. The prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. Most patients with small cell lung cancer have a long history of smoking, and the tumor mutation burden is relatively high, which provides potential for immunological checkpoint inhibitors represented by PD-1 antibodies. A number of studies have shown that chemotherapy combined with adoptive cellular immunotherapy could prolong the survival of patients. This study is a clinical study to explore the efficacy and safety of maintenance therapy with sintilimab after 4-6 cycles of first-line chemotherapy combined with adoptive cellular immunotherapy in patients with advanced small cell lung cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Study Start: 2019-06-20
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-11
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• small cell lung cancer confirmed by pathology
• extensive small cell lung cancer by imaging
• at least one measurable lesion by RECIST 1.1
• ECOG 0-1
• adequate organ function
• no other severe diseases conflicting with this regimen (such as autoimmune diseases, immunodeficiency, organ transplantation, etc)
• no history of other maliganancies
• Women of childbearing period must examinate for a negative pregnancy test within 7 days, use appropriate contraceptive measures during the study and 6 months after the trial.
• agreement to participate in the study and signed informed consent from the patients

Exclusion Criteria

• serious infectious diseases four weeks before enrollment
• requirement intermittent use of bronchodilators or medical interventions;
• the use of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks;
• severe allergies
• severe mental disorders
• abnormal coagulation function
• previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc.
• other situations considered by investigators not meet the inclusion criteria (including but not limited to symptomatic brain metastases)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	sintilimab maintenance	phlebotomation 50ml 1-7 days before chemotherapy for culture of R-CIK cells chemotherapeutic regimen EP or EC as follows: VP-16 100mg/m2 D1-3 plus cisplatin 75mg/m2 D1 or VP-16 100mg/m2 D1-3 plus carboplatin AUC=5 D1 R-CIK cells were transfused back to the patients 2-7 days after the end of chemotherapy, and the amount of R-CIK cells returned each time was about 5×109 three weeks each cycle efficacy evaluated every two cycles patients with the efficay is CR, PR or SD after 4-6 cycles enter the sintilimab maintenance therapy for one year or until the progression of disease, or occurrence of intolerable adverse events. the dose of sintilimab is fixed dose of 200mg every three weeks

Primary Outcome Measures

Name	Time	Method
median survival time	two years.	the period from the day of enrollment to the date of death

Secondary Outcome Measures

Name	Time	Method
progression-free survival	six months	the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first.
objective response rate of sintilimab	six month	from the date of first dose of sintilimab to the date of confirmed progression following
adverse events rate of sintilimab	one year	the rate of adverse events during the maintenance therapy of sintilimab

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China