A Phase II Study of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
A Multicenter, Randomized, Open-Label, Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HS-20093 Injection Combined With Adebrelimab Versus HS-20093 Injection in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
調査の概要
詳細な説明
This is a multicenter, randomized, open-label, controlled phase II clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus HS-20093 injection in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.
Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093 and adebrelimab) or the control arm (HS-20093 injection). Participants in the experimental arm will receive intravenous infusions of HS-20093 and adebrelimab until disease progression or other treatment discontinuation criteria are met. Participants in the control arm will receive HS-20093 injection until disease progression or other treatment discontinuation criteria are met. Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedures.
研究の種類
入学 (推定)
段階
- フェーズ2
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:
- Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
- Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
- Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC).
- Presence of at least one measurable target lesion.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
- Minimum life expectancy >12 weeks.
- Adequate organ function.
- Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
- Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.
Exclusion Criteria:
- Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.
Prior or ongoing treatment with any of the following:
- Prior or current treatment targeting B7-H3;
- Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.;
- Prior treatment with docetaxel monotherapy or in combination with other agents.
- Persistent adverse reactions caused by prior treatment.
- Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms).
- History of other primary malignancies.
Presence of any of the following abnormal cardiac findings:
- Evidence of currently clinically significant important arrhythmia or ECG abnormality;
- Presence of risk factors causing QT interval prolongation or arrhythmic events.
- Severe, uncontrolled, or active cardiovascular or cerebrovascular disease.
- Severe or poorly controlled hypertension.
- Severe or poorly controlled diabetes mellitus.
- Clinically significant bleeding symptoms or significant bleeding tendency.
- Severe infection.
- History of severe arterial or venous thromboembolic events.
- Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
- Participants with active or history of autoimmune disease with potential for recurrence.
- Prior occurrence of severe or life-threatening immune-mediated adverse events.
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:HS-20093とアデブレリマブ
|
The patient will be treated with HS-20093.
他の名前:
The patient will be treated with Adebrelimab
|
|
アクティブコンパレータ:HS-20093
|
The patient will be treated with HS-20093.
他の名前:
|
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 |
|---|---|---|
|
Objective Response Rate (ORR)
時間枠:Up to 3 years
|
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
|
Up to 3 years
|
|
Progression-Free Survival (PFS)
時間枠:Approximately 3 years
|
2. Progression-Free Survival (PFS) assessed by investigator per RECIST v1.1
|
Approximately 3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
duration of response (DoR)
時間枠:Approximately 3 years
|
DoR assessed by investigator per RECIST v1.1
|
Approximately 3 years
|
|
Overall survival (OS)
時間枠:Approximately 5 years
|
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
|
Approximately 5 years
|
|
Adverse event (AE) and serious adverse event (SAE)
時間枠:3 years
|
Incidence and severity of AEs and SAEs
|
3 years
|
|
Changes from baseline in cardiac function [electrocardiogram (ECG)]
時間枠:3 years
|
Changes from baseline in cardiac function [electrocardiogram (ECG)].
For all ECGs performed during the study, the following parameters will be recorded and assessed: cardiac rhythm, heart rate, PR interval, RR interval, QRS duration, and QT interval (with QTcF correction using Fridericia's formula).
A global interpretation of the ECG tracing will also be provided.
|
3 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
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