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

• Status: Unknown status
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital

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)