Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC
A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
調査の概要
詳細な説明
This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year.
Explore objective is potential biomarker associated with efficacy.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前:Changli Wang, PhD
- 電話番号:6417 86-22-23340123
- メール:wangchangli@medmail.com.cn
研究連絡先のバックアップ
- 名前:Lianming Zhang, PhD
- 電話番号:6417 86-22-23340123
研究場所
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Tianjin、中国、300060
- 募集
- Tianjin Medical University Cancer Institute and Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients aged ≥18 years, male and female are not limited;
- Patients with ECOG score of 0-1;
- Life expectancy ≥12 weeks;
- Patients must have histologically- or cytologically-documented NSCLC (according to 2015 WHO Classification);
- Patients with stage I - IIA (T1-T2bN0M0, tumor size ≤ 50mm) confirmed by radiographic;and medical inoperable, unable to undergo thoracic surgery, or refusing to surgery (according to the eighth edition of TNM staging);
- Patients with measurable target lesions according to the RECIST 1.1 standard;
- Patients have not received prior treatment for their NSCLC, including radiotherapy, chemotherapy, surgery and target drugs;
- Can provide tumor tissue;
- Adequate organ and marrow function;
- Fertile female were required to have a serum or urine pregnancy test within 72 hours before the start dose of study medication and the result has been negative;If female of childbearing potential, is willing to use adequate contraception for the course of the study through 90 days after the last dose of study medication; if male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 90 days after the last dose of study medication;
- Provision of signed ICF.
Exclusion Criteria:
- Known any distance metastases;
- Patients with known EGFR gene mutation or ALK fusion mutation;
- Patients with any active autoimmune disease or history of autoimmune disease;
- Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co-infection with hepatitis B and hepatitis C;
- Subjects requiring systemic treatment with corticosteroids (> 10 mg / day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
- Patient must not have received a live, attenuated vaccine within 4 weeks prior to the first administration;
- Any therapy for NSCLC treatment;
- Patients with other malignant tumors in the past 5 years;
- Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
- Patients with cardiac insufficiency;
- Routine urine test indicated that urine protein was >= (+ +), or 24-hour urine protein was >= 1g, or severe liver and kidney dysfunction;
- Patients with severe infection or fever of unknown origin >38.5 ℃ within 4 weeks prior to the first administration;
- Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
- Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients or to pemetrexed or to nab-paclitaxel;
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results,or the patient is unlikely to comply with study procedures, restrictions, and requirements.
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: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 |
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実験的:Camrelizumab combined with chemotherapy
Participants receive camrelizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 18 cycles PLUS Investigator's choice of chemotherapy. Interventions: Biological: Camrelizumab |
化学療法
他の名前:
PD-1
他の名前:
chemotherapy
他の名前:
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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)
時間枠:up to approximately 3 years
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PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
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up to approximately 3 years
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二次結果の測定
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 is defined as the first date of treatment to date of death from any causes.
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up to approximately 5 years
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Objective response rate (ORR)
時間枠:up to approximately 1 years
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ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator.
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up to approximately 1 years
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Disease Control Rate (DCR)
時間枠:up to approximately 3 years
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DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator..
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up to approximately 3 years
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Adverse Events (AEs)
時間枠:up to 18 months
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The number of participants experiencing an AE will be assessed.
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up to 18 months
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12か月のPFS(PFS12)
時間枠:最大12か月まで
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PFS は、Kaplan-Meier プロダクト リミット法を使用して計算されます。
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最大12か月まで
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PFS at 24 months (PFS24)
時間枠:up to maximum 24 months
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PFS will be calculated using Kaplan-Meier product limit methods.
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up to maximum 24 months
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PFS at 5 years
時間枠:up to maximum 5 years
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PFS will be calculated using Kaplan-Meier product limit methods.
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up to maximum 5 years
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12 か月の OS (OS12)
時間枠:最大12か月まで
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OS は、Kaplan-Meier プロダクト リミット法を使用して計算されます。
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最大12か月まで
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24 か月の OS (OS24)
時間枠:最大24ヶ月
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OS は、Kaplan-Meier プロダクト リミット法を使用して計算されます。
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最大24ヶ月
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OS at 5 years
時間枠:up to maximum 5 years
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OS will be calculated using Kaplan-Meier product limit methods.
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up to maximum 5 years
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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 (予想される)
研究の完了 (予想される)
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
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
- MA-NSCLC-II-007
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
米国FDA規制機器製品の研究
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ペメトレキセドの臨床試験
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Instituto Nacional de Cancer, BrazilEli Lilly and Company完了