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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983759
• Other study ID #: HenanCH immunotherapy002
• Status: Recruiting
• Phase: Phase 2
• Start date: June 20, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2019
• Source: Henan Cancer Hospital
• Contact: Quanli Gao, Dr.
• Phone: +86-15038171966
• Email: gaoquanli2015[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adoptive Cellular Immunotherapy
• Chemotherapy
• Extensive Disease
• Lung Neoplasms
• Maintenance
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median survival time	the period from the day of enrollment to the date of death	two years.
Secondary	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
Secondary	objective response rate of sintilimab	from the date of first dose of sintilimab to the date of confirmed progression following	six month
Secondary	adverse events rate of sintilimab	the rate of adverse events during the maintenance therapy of sintilimab	one year