Limited-stage Small Cell Lung Cancer (LS-SCLC)
Conditions
Interventions
- Arm A: Tifcemalimab (200 mg intravenous infusion [IV]) with toripalimab (240 mg IV) once every 3 weeks (Q3W)
- Arm B: Placebo for tifcemalimab (IV) with toripalimab (240 mg IV) Q3W
- Arm C: Placebos
Sponsors
Zhang Kui
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female with age >= 18 years old at the time of informed consent. 2. Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) using the Veteran's Administration Lung Study Arm (VALSG) staging criteria. Patients with TNM Stage I or II disease per AJCC 8th edition must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery. 3. Received chemoradiotherapy (CRT) defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-66 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy. 4. Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1. 6. Adequate organ function 7. Female patients of childbearing potential and male patients whose partners are women of childbearing age. If the female patients participated the clinical trial by interrupting breastfeeding, they are required not to breastfeed during treatment within and for 4 months after the last dose tifcemalimab/placebo or toripalimab/placebo. 8. Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Mixed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). 2. Received sequential chemoradiotherapy for LS-SCLC. 3. Failure to recover from toxicity of prior anticancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade = 500 IU/mL), hepatitis C (hepatitis C antibodies positive and HCV-RNA higher than the lower limit of detection of the analytical method). 8. Any other malignancy diagnosed prior to the first dose of investigational intervention, except those with a low risk for the development of metastases (5-year survival rate > 90%), such as adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated localized prostate cancer. 9. Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) [Time Frame: up to 3years] To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by OS OS [Time Frame: up to 3years] To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS Progression-free survival (PFS) [Time Frame: up to 2years] To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS PFS [Time Frame: up to 2years] To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by OS and BIRC-assessed PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS [Time Frame: up to 2years] To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by Investigator-assessed PFS 1-year OS rate [Time Frame: up to 1year] To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by 1-year OS rate 2-year OS rate [Time Frame: up to 2 years] To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by 2-year OS rate Objective response rate (ORR) [Time Frame: up to 2 years] To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by ORR Disease control rate (DCR) [Time Frame: up to 2 years] To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by DCR Duration of response (DoR) [Time Frame: up to 2years] To compare and evaluate the efficacy of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by DoR PFS [Time Frame: up to 2 years] To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by Investigator-assessed PFS 1 year OS rate [Time Frame: up to 1 years] To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLS as measured by 1-year OS rate 2 year OS rate [Time Frame: up to 2 years] To compare and evaluate the efficacy of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT | — |
Countries
Belgium, China, France, Georgia, Germany, Italy, Japan, Poland, Romania, South Korea, Spain, Taiwan, Turkey, United States
Contacts
Public ContactChikako Rosario
Parexel International Inc.
Outcome results
None listed