Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)

JRCT ID: jRCT2021240012

Registered date:24/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Limited-stage Small Cell Lung Cancer (LS-SCLC)
• Date of first enrollment: 31/08/2024
• Target sample size: 79
• Countries of recruitment: Belgium,Japan,China,Japan,France,Japan,Georgia,Japan,Germany,Japan,Italy,Japan,Poland,Japan,Romania,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

- 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 for both tifcemalimab and toripalimab (IV) Q3W

Outcome(s)

Primary Outcome

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 Outcome

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 for patients with LS-SCLS as measured by 2-year OS rate
ORR [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 ORR
DCR [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 DCR
DoR [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 DoR
Safety [Time Frame: up to 2 years]
To compare and evaluate the safety of tifcemalimab and toripalimab (Arm A) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters.
Safety [Time Frame: up to 2 years]
To compare and evaluate the safety of toripalimab (Arm B) versus placebo (Arm C) as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 <= 1 (except alopecia) or levels specified in the inclusion/exclusion criteria, whichever is more severe.
4. Patients with active autoimmune disease, history of autoimmune disease.
5. History of immunodeficiency, including human immunodeficiency virus (HIV) seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
6. History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).
7. The presence of active hepatitis B (HBV DNA >= 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.

Related Information

• Primary Sponsor: Zhang Kui
• Secondary ID(s): NCT06095583