Patients with limited-stage small cell lung cancer (LS-SCLC) without disease progression after chemoradiotherapy (CRT)
Conditions
Brief summary
OS, BIRC-assessed PFS (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1).
Detailed description
Investigator-assessed PFS, 1-year and 2-year OS rates, - Investigator-assessed ORR - Investigator-assessed DCR. - Investigator-assessed DoR., - Safety: incidence of AEs, abnormal laboratory parameters. - PK of tifcemalimab and toripalimab: trough concentrations. - Immunogenicity of tifcemalimab and of toripalimab: incidence and titers of anti-drug antibodies (ADAs) and, if ADA positive, neutralizing antibodies (NAbs).
Interventions
Sponsors
Shanghai Junshi Biosciences Co. Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS, BIRC-assessed PFS (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator-assessed PFS, 1-year and 2-year OS rates, - Investigator-assessed ORR - Investigator-assessed DCR. - Investigator-assessed DoR., - Safety: incidence of AEs, abnormal laboratory parameters. - PK of tifcemalimab and toripalimab: trough concentrations. - Immunogenicity of tifcemalimab and of toripalimab: incidence and titers of anti-drug antibodies (ADAs) and, if ADA positive, neutralizing antibodies (NAbs). | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland, Romania, Spain
Outcome results
None listed