Clinical trial NCT03983759: Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Extensive Disease
Adoptive Cellular Immunotherapy
Chemotherapy
Maintenance
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: median survival time
timeFrame: two years.
Secondary outcomes:
measure: progression-free survival
timeFrame: six months
measure: objective response rate of sintilimab
timeFrame: six month
measure: adverse events rate of sintilimab
timeFrame: one year
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Jing Ding, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.