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

Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy

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.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer; Chemotherapy; Adoptive Cellular Immunotherapy; Maintenance; Extensive Disease
• Intervention / Treatment: Drug: sintilimab maintenance

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: treatment group; 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

Drug: sintilimab maintenance; the patients with CR, PR or SD after the chemotherapy plus R-CIK will receive sintilimab maintenance therapy. The dose of sintilimab is fixed at 200mg every three weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
median survival time	the period from the day of enrollment to the date of death	two years.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Publications and helpful links

General Publications

• Ma B, Zhou Y, Shang Y, Zhang Y, Xu B, Fu X, Guo J, Yang Y, Zhang F, Zhou M, Huang H, Li F, Lin H, Zhao L, Wang Z, Gao Q. Sintilimab maintenance therapy post first-line cytokine-induced killer cells plus chemotherapy for extensive-stage small cell lung cancer. Front Oncol. 2022 Sep 9;12:852885. doi: 10.3389/fonc.2022.852885. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2019
• Primary Completion (ANTICIPATED): May 31, 2021
• Study Completion (ANTICIPATED): May 31, 2021

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (ACTUAL): June 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: HenanCH immunotherapy002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No