A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
2026年8月30日 更新者：Qilu Pharmaceutical Co., Ltd.
A Phase III, Randomized, Controlled, Open-label Clinical Study to Compare the Efficacy and Safety of QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy as First-line Treatment in Participants With Extensive-stage Small Cell Lung Cancer
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 in combination with QL2107 versus Tislelizumab plus platinum and etoposide as first-line treatment in participants with extensive-stage small cell lung cancer.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
556
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Haiying Yu, Bachelor
- 電話番号：+86-17821799566
- メール：haiying.yu@qilu-pharma.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Age ≥18 years.
- Participants with histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the Veterans Administration Lung Cancer Study Group (VALG) staging system.
- No prior systemic treatment for ES-SCLC.
- At least one extracranial measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, without deterioration within 2 weeks prior to the first dose of study treatment.
- Life expectancy ≥12 weeks.
- Has adequate organ function.
- Male and female participants of reproductive/childbearing potential must agree to avoid pregnancy.
- Voluntarily sign the written informed consent form and comply with the protocol requirements.
Exclusion Criteria:
Has received or undergoing any of the following treatment:
Previous or current treatment with B7-H3 targeted therapy. Previous or current treatment with topoisomerase I inhibitors.
- Participants with transformed Non-Small Cell Lung Cancer (NSCLC), epidermal growth factor receptor (EGFR) mutation-positive NSCLC that has transformed to SCLC, or mixed SCLC-NSCLC histology.
- Presence with active brain metastases, leptomeningeal metastasis, brainstem metastasis or spinal cord compression.
- Radiotherapy with a limited field of radiation within 2 weeks prior to the study treatment; more than 30% of the bone marrow irradiation or large-scale radiotherapy within 4 weeks prior to study treatment.
- Major surgery within 4 weeks prior to the study treatment.
- Unresolved AEs ≥ Grade 2 (CTCAE v6.0) from prior therapy.
- Previous or concurrent primary malignancies.
- History of severe heart disease or cerebrovascular disease.
- History of Severe or uncontrolled hypertension or diabetes mellitus.
- Severe infection within 4 weeks prior to study treatment; or uncontrolled active infection at screening.
- Known or suspected interstitial lung disease/non-infectious pneumonitis; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity.
- Known history of pre-existing or newly diagnosed autoimmune disease.
- History of severe neuropathy or mental disorders.
- History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to study drugs or any components of the study drugs.
- Unlikely to comply with study procedures and requirements in the opinion of the investigator.
- Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：QLC5508 in combination with QL2107
|
QLC5508 will be administered intravenously once every 3 weeks.
Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first.
QL2107 will be administered intravenously once every 3 weeks.
Treatment will continue until disease progression or unacceptable toxicity.
The maximum treatment duration for QL2107 will be 2 years.
|
|
アクティブコンパレータ：Tislelizumab in Combination with Platinum-based Chemotherapy
|
Tislelizumab will be administered intravenously once every 3 weeks.
Treatment will continue until disease progression or unacceptable toxicity.
The maximum treatment duration for Tislelizumab will be 2 years.
Carboplatin will be administered intravenously once every 3 weeks.
Carboplatin treatment will be administered for up to 4 cycles.
Cisplatin will be administered intravenously once every 3 weeks.
Cisplatin treatment will be administered for up to 4 cycles.
Etoposide will be administered intravenously once every 3 weeks.
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 36 months
|
OS is defined as the duration from the date of randomization to the date of death due to any cause.
|
Up to approximately 36 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)
時間枠：Up to approximately 36 months
|
PFS is defined as the duration from the date of randomization to the date of first documented progressive disease (PD) based on investigator assessment, or death from any cause, whichever occurs first.
|
Up to approximately 36 months
|
|
Objective response rate (ORR)
時間枠：Up to approximately 36 months
|
ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria.
|
Up to approximately 36 months
|
|
Duration of response (DOR)
時間枠：Up to approximately 36 months
|
DOR is defined as the duration from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
|
Up to approximately 36 months
|
|
Disease control rate (DCR)
時間枠：Up to approximately 36 months
|
DCR is defined as the percentage of participants achieved complete response, partial response, or stable disease as assessed according to RECIST v1.1 criteria.
|
Up to approximately 36 months
|
|
6-month PFS rate
時間枠：Up to approximately 36 months
|
The 6-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 6 months from the date of randomization.
|
Up to approximately 36 months
|
|
12-month PFS rate
時間枠：Up to approximately 36 months
|
The 12-month PFS rate is defined as the proportion of participants who have not experienced PD and who are alive at 12 months from the date of randomization.
|
Up to approximately 36 months
|
|
12-month OS rate
時間枠：Up to approximately 36 months
|
The 12-month OS rate is defined as the proportion of participants who are alive at 12 months from the date of randomization.
|
Up to approximately 36 months
|
|
24-month OS rate
時間枠：Up to approximately 36 months
|
The 24-month OS rate is defined as the proportion of participants who are alive at 24 months from the date of randomization.
|
Up to approximately 36 months
|
|
Treatment Emergent Adverse Event (TEAE)
時間枠：Up to approximately 36 months
|
TEAEs are defined as any adverse event (AE) that occurs after the initiation of study treatment, or any pre-existing condition that worsens in severity or frequency after the initiation of study treatment, regardless of the causal relationship to the study 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 36 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月15日
一次修了 (推定)
2029年3月15日
研究の完了 (推定)
2030年6月15日
試験登録日
最初に提出
2026年8月30日
QC基準を満たした最初の提出物
2026年8月30日
最初の投稿 (実際)
2026年9月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年8月30日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- QLC5508-304
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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