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Efficacy and Safety Study of Anlotinib With Pembrolizumab in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Non-small Cell Lung Cancer

2019年11月13日 更新者:Li Zhang、Peking Union Medical College Hospital

The purpose of this study is to assess the safety and efficacy of Anlotinib (AL3818) combined with pembrolizumab (MK-3475) in treatment-naïve adults with no prior systemic therapy for advanced non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

The primary study hypotheses is that the combination of Anlotinib and pembrolizumab is superior to pembrolizumab alone(historical data) as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

調査の概要

状態

わからない

条件

研究の種類

介入

入学 (予想される)

49

段階

  • フェーズ2

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

研究場所

    • Beijing
      • Beijing、Beijing、中国、100730
        • 募集
        • Peking Union Medical College Hospital
        • コンタクト:

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. volunteered to join the study, signed the informed consent, had good compliance and cooperated with the follow-up.
  2. age: ≥18 years old.
  3. Histologically or cytologically confirmed locally advanced NSCLC(not suitable for or refuse to do radical radiotherapy and chemotherapy)/advanced NSCLC, have not previously received systemic treatment for locally advanced or advanced NSCLC. The completion time of previous neoadjuvant / adjuvant treatment for recurrent subjects should be ≥ 6 months.
  4. Negative in EGFR,ALK and ROS1(tumor tissue sample results).
  5. Has tumor tissue that demonstrates PD-L1 expression in ≥1% of tumor cells (TPS≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay at a central laboratory.
  6. Diagnosed with advanced or recurrent NSCLC through pathology, with measurable nidus(using RECIST 1.1).
  7. Has a life expectancy of ≥3 months.
  8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  9. Has adequate organ function:

    1. .HB≥90g/L;
    2. ANC≥1.5×109/L;
    3. PLT≥100×109/L;
    4. WBC≥4.0×109/L and ≤15×109/L;
    5. ALT and AST≤1.5×ULN(≤5×ULN in patients with liver metastases);
    6. ALP≤2.5×ULN;
    7. TBiL≤1.5×ULN;
    8. ALB≥30g/L;
    9. TSH≤ULN(If abnormal, T3 and T4 levels should be examined; If T3 and T4 levels are normal, they can be enrolled);
    10. Cr≤1.5×ULN,and CrCL≥60mL/min(Cockcroft-Gault).
  10. The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 4 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 120 days after it.

Exclusion Criteria:

  1. Has an active autoimmune disease that has required systemic treatment. Replacement therapy is not considered a form of systemic treatment and is allowed.
  2. Is receiving systemic steroid therapy within 3 days before the first dose of study treatment.
  3. Live vaccines were administered within 4 weeks or possibly during the study.
  4. Gene test results of tissue or blood samples confirmed the existence of EGFR, ALK and ROS1 variants.
  5. CT or MRI showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a large local invasion Blood vessels, or central tumor with high risk of bleeding, or obvious cavitary or necrotic tumor of lung.
  6. Has active central nervous system metastasis (subjects who have completed treatment 21 days before randomization and have stable symptoms can be enrolled, but they need to be confirmed by imaging evaluation as no active bleeding symptoms, and have stopped systemic agitation Hormone therapy: dosage > 10mg / day prednisone or other effective hormones.
  7. Has received prior therapy with Anlotinib, anti-PD-1(L1) or anti-CTLA-4 agents.
  8. Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for ≥5 years since initiation of that therapy.
  9. Has significant cardiovascular impairment, such as a history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction within 12 months of the first dose of study treatment, or cardiac arrhythmia associated with hemodynamic instability.
  10. Has uncontrolled blood pressure (defined as systolic pressure≥140 mm Hg or diastolic pressure≥90 mm Hg).

    Has had an allogeneic tissue/solid organ transplant.

  11. Abnormal coagulation (INR > 1.5 or PT > ULN + 4S or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulation. Note: on the premise of INR ≤ 1.5, it is allowed to use low-dose heparin (daily dosage for adults is 6000-12000 U) or low-dose aspirin (daily dosage ≤ 100mg) for prevention purposes.
  12. Has arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism.
  13. Has had clinically significant hemoptysis within 3 months before the study (more than 50ml hemoptysis per day); or clinically significant bleeding symptoms or clear bleeding tendency (such as gastrointestinal bleeding, bleeding gastric ulcer, Gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood + + or above in baseline, or suffer from vasculitis, etc.
  14. Urine routine indicates urine protein ≥ + +, or confirms 24-hour urine protein content ≥ 1.0g.
  15. Has congenital or acquired immune deficiency (such as HIV infection), or active hepatitis.
  16. Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  17. Take major surgical treatments, open biopsy, or get overt traumatic injury within 28 days before enrollment.
  18. Has a previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.
  19. Has received allogeneic cell / tissue / organ transplantation.
  20. According to the judgment of the researcher, there are other factors that may cause the study to be forced to terminate halfway, For example, other serious diseases (including mental diseases) need to be treated in combination, with serious laboratory abnormalities, and Court or social factors.

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:なし
  • 介入モデル:単一グループの割り当て
  • 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:Experimental: Anlotinib plus Pembrolizumab
Participants receive Anlotinib 12 mg p.o, qd on Days 1-14 of each 3-week cycle until progressive disease or unacceptable toxicity plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
Participants receive Anlotinib 12 mg p.o, qd on Days 1-14 of each 3-week cycle until progressive disease or unacceptable toxicity plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).

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
Progression-free Survival (PFS) as assessed by RECIST 1.1
時間枠:Up to approximately 24 months
PFS is defined as the time from date of enrollment to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST 1.1.
Up to approximately 24 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR) as assessed by RECIST 1.1
時間枠:Up to approximately 24 months
ORR is defined as the percentage of participants in the analysis population who have a Complete Response(CR) or a Partial Response(PR) per RECIST 1.1.
Up to approximately 24 months
Disease Control Rate (DCR) as assessed by RECIST 1.1
時間枠:Up to approximately 24 months
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease per RECIST 1.1.
Up to approximately 24 months
Overall Survival (OS)
時間枠:Up to 12 months after last patient last visit
OS is defined as the time from date of enrollment to date of death from any cause.
Up to 12 months after last patient last visit
Progression Free Survival 2 (PFS2)
時間枠:Up to 12 months after last patient last visit
PFS2 will be defined as beginning with enrollment and ending with the first of the following events: a) death; b) disease progression on any treatment given after 1st progression. The determination of disease progression will be based on RECIST 1.1 criteria.
Up to 12 months after last patient last visit
Toxicity Rate
時間枠:Up to 12 months after last patient last visit
Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing adverse event (AE) including AE of all level, AE of grade 3/4, irAE
Up to 12 months after last patient last visit

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。

捜査官

  • 主任研究者:LI zhang, master、Peking Union Medical College Hospital, Beijing, China

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 (予想される)

2019年11月16日

一次修了 (予想される)

2021年11月16日

研究の完了 (予想される)

2022年11月16日

試験登録日

最初に提出

2019年11月13日

QC基準を満たした最初の提出物

2019年11月13日

最初の投稿 (実際)

2019年11月15日

学習記録の更新

投稿された最後の更新 (実際)

2019年11月15日

QC基準を満たした最後の更新が送信されました

2019年11月13日

最終確認日

2019年11月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

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

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。

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