A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of YL201 in Combination With Serplulimab Versus Carboplatin and Etoposide in Combination With Serplulimab as First-line Treatment in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：MediLink Study Team
- 電話番号：+86 512 62858368
- メール：clinicaltrials@medilinkthera.com
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510060
- 募集
- Sun Yat-sen University Cancer Center
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コンタクト：
- Study Coordinator
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Liaoning
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Shenyang、Liaoning、中国、110042
- 募集
- Liaoning Cancer Hospital & Institute
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コンタクト：
- Study Coordinator
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Voluntarily sign the written informed consent form and comply with the protocol requirements
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- No prior systemic treatment for ES-SCLC.
- At least one extracranial measurable lesion according to RECIST v1.1.
- Adequate organ function.
- Life expectancy ≥3 months.
Exclusion Criteria:
- Any histological types of transformed SCLC or combined SCLC.
- History of immune-related adverse events (irAEs) of CTCAE Grade ≥3 during prior immunotherapy, or unresolved adverse events from previous antitumor therapy.
- Major surgery (excluding diagnostic procedures) or severe trauma within 4 weeks prior to randomization or planned major surgery during the study period.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Presence of active brain metastases, brainstem metastases, or leptomeningeal metastases.
- Presence of severe and uncontrolled cardiovascular or cerebrovascular disease.
- History of interstitial lung disease (ILD) /pneumonitis requiring steroid treatment, or current diagnosis of ILD/pneumonitis, or concurrent pulmonary disease leading to clinically severe impairment of respiratory function.
- Active autoimmune or inflammatory diseases within 2 years prior to randomization.
- Severe infection within 4 weeks prior to randomization, or active infection requiring intravenous anti-infective therapy within 2 weeks or oral anti-infective therapy within 1 week prior to randomization.
- Known active tuberculosis or active syphilis infection.
- History of immunodeficiency or positive for human immunodeficiency virus (HIV) antibodies test.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Participants with inactive HBV infection must receive antiviral therapy throughout the study.
- History of other primary malignancies within 5 years prior to randomization.
- Known hypersensitivity to any component of the investigational product.
- Females who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study period.
- Any condition that, in the opinion of the investigator, would make the participant unsuitable for study participation.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：YL201 in combination with serplulimab
Participants will receive YL201 in combination with serplulimab until disease progression or unacceptable toxicity, whichever occurs first.
The total number of treatment cycles of YL201 in this study is not fixed, and the maximum duration of serplulimab treatment is 2 years.
|
YL201 will be administered by intravenous infusion at a dose of 2.0 mg/kg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed,
他の名前：
Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for serplulimab will be 2 years. |
|
アクティブコンパレータ：Carboplatin and etoposide in combination with serplulimab
Participants will receive 4 cycles of carboplatin plus etoposide in combination with serplulimab as induction therapy, followed by maintenance treatment with serplulimab for up to 2 years.
|
Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for serplulimab will be 2 years. Carboplatin will be administered by intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle. Carboplatin treatment will be administered for up to 4 cycles. Etoposide will be administered by intravenous infusion at a dose of 100 mg/m2 on Days 1 to 3 of each 3-week cycle. Etoposide treatment will be administered for up to 4 cycles. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival (OS)
時間枠：Up to approximately 5 years
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OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause.
OS was estimated using KM methodology.
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Up to approximately 5 years
|
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Progression-free survival (PFS) as assessed by BIRC
時間枠：Up to approximately 30 months
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PFS, as assessed by Blinded Independent Review Committee (BIRC), is defined as the time from randomization to the first documented progressive disease (PD) based on BIRC imaging assessment, or death from any cause, whichever occurs first.
|
Up to approximately 30 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free survival (PFS) as assessed by investigator
時間枠：Up to approximately 30 months
|
PFS assessed by investigator is defined as the time from randomization to the first documented PD based on investigator assessment, or death from any cause, whichever occurs first.
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Up to approximately 30 months
|
|
Objective response rate (ORR)
時間枠：Up to approximately 30 months
|
ORR is defined as the percentage of participants with (confirmed) complete response or partial response as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
|
Up to approximately 30 months
|
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Disease control rate (DCR)
時間枠：Up to approximately 30 months
|
DCR is defined as the percentage of participants with (confirmed) complete response, partial response, or stable disease as assessed according to RECIST v1.1
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Up to approximately 30 months
|
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Duration of response (DOR)
時間枠：Up to approximately 30 months
|
DOR is defined as the time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
|
Up to approximately 30 months
|
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Time to response (TTR)
時間枠：Up to approximately 30 months
|
TTR is defined as the time from randomization to the first documented objective response.
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Up to approximately 30 months
|
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Treatment Emergent Adverse Event (TEAE)
時間枠：Up to approximately 30 months
|
Treatment-emergent adverse events (TEAEs) are defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new onset or worsening) that occurs after initiation of YL201, or any worsening of a pre-existing condition during YL201 treatment. TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0. |
Up to approximately 30 months
|
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Pharmacokinetic (PK) characteristics
時間枠：Up to approximately 30 months
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PK parameters of YL201 and serplulimab will be evaluated.
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Up to approximately 30 months
|
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Anti-drug antibody (ADA)
時間枠：Up to approximately 30 months
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Frequency of anti-YL201 antibody (ADA) will be investigated.
|
Up to approximately 30 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。