未治療、PD-L1 発現、局所進行または転移性 NSCLC における NT-I7 とアテゾリズマブの併用
未治療、PD-L1 発現、局所進行性または転移性 NSCLC の被験者を対象に、アテゾリズマブと組み合わせた NT-I7 の抗腫瘍効果と安全性を評価するための多施設非盲検単一群第 II 相試験
調査の概要
詳細な説明
The main purpose of this study is to assess the preliminary anti-tumor activity of NT-I7 in combination with atezolizumab in subjects with programmed cell death ligand 1 (PD-L1)-expressing (tumor proportion score [TPS] ≥ 1%), locally advanced or metastatic squamous or non-squamous non-small cell lung cancer (NSCLC) who have not received prior systemic therapy for locally advanced or metastatic disease. The primary objective is evaluated based on the objective response rate (ORR) as assessed by investigators using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and immune RECIST (iRECIST).
Secondary objectives include further evaluation of the anti-tumor activity and efficacy of the combination therapy based on the duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) per RECIST 1.1 and iRECIST. In addition, the safety and tolerability of NT-I7 will be evaluated.
One treatment cycle is defined as 21 days (3 weeks). Atezolizumab is administered at a dose of 1200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle. NT-I7 is administered at a dose of 1200 μg/kg via intramuscular (IM) injection once every 6 weeks (Q6W) on Day 1 of alternating cycles, starting on Cycle 1 Day 1. On days when both study drugs are administered, atezolizumab is given prior to NT-I7.
Each subject may participate for a maximum of 35 cycles (approximately 2 years) of study treatment. The last safety follow-up visit will occur 90 days after the last dose, meaning the total participant duration could be up to 27 months.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Alabama
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Mobile、Alabama、アメリカ、36604
- University of South Alabama
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California
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Cerritos、California、アメリカ、90703
- TOI Clinical Research
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Connecticut
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Norwich、Connecticut、アメリカ、06360
- Eastern CT Hematology & Oncology Associates
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Florida
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Fort Myers、Florida、アメリカ、33916
- Florida Cancer Specialists - South Research Office
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Plantation、Florida、アメリカ、33322
- BRCR Medical Center
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St. Petersburg、Florida、アメリカ、33705
- Florida Cancer Specialists - North Research Office
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West Palm Beach、Florida、アメリカ、33401
- Florida Cancer Specialists - East Research Office
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Georgia
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Athens、Georgia、アメリカ、30607
- University Cancer and Blood Center
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Indiana
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Goshen、Indiana、アメリカ、46526
- Goshen Center for Cancer Care
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Kentucky
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Louisville、Kentucky、アメリカ、40217
- Norton Cancer Institute
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Pikeville、Kentucky、アメリカ、41501
- Pikeville Medical Center, Inc.
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Maine
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South Portland、Maine、アメリカ、04106
- MaineHealth Cancer Care
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Maryland
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Salisbury、Maryland、アメリカ、21801
- TidalHealth Peninsula Regional, Inc.
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New Jersey
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Florham Park、New Jersey、アメリカ、07932
- Summit Health Medical Center
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North Carolina
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Greenville、North Carolina、アメリカ、27834
- East Carolina University
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Ohio
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Columbus、Ohio、アメリカ、43219
- Zangmeister Cancer Center
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Oregon
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Portland、Oregon、アメリカ、97239
- OHSU Knight Cancer Institute
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Tennessee
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Chattanooga、Tennessee、アメリカ、37404
- Tennessee Oncology - Chattanooga
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Knoxville、Tennessee、アメリカ、37916
- Thompson Cancer Survival Center
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Nashville、Tennessee、アメリカ、37203
- Tennessee Oncology - Nashville
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Texas
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El Paso、Texas、アメリカ、79915
- Renovatio Clinical - El Paso
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The Woodlands、Texas、アメリカ、77380
- Renovatio Clinical - The Woodlands
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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
説明
包含基準:
- -組織学的または細胞学的に確認された転移性または局所進行NSCLCがあり、以前に全身療法を受けていません。 -局所進行疾患の被験者は、ステージIIIのNSCLCを持っている必要があり、外科的切除または決定的な化学放射線療法の候補ではありません
- PD-L1 22C3免疫組織化学局所または中央アッセイによって決定された腫瘍PD-L1発現（TPS≧1％）。
- 測定可能な疾患がある
- PD-L1を評価するためのスクリーニング時にスクリーニング生検（またはアーカイブ組織）を提供することに同意する
- エコグ 0-1
- -適切な血液学的機能および末端臓器機能
除外基準:
- -以前の全身抗がん療法
- EGFR、ALK、BRAF、ROS、RED、または利用可能な治療法があるその他のゲノム腫瘍異常を伴うNSCLC
- -研究治療の開始から2週間以内の以前の放射線療法
- -既知の活動性CNS転移または癌性髄膜炎
- mAb または IV 免疫グロブリン製剤に対する重度の反応
- 過去2年間の自己免疫疾患の病歴
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：NT-I7 とアテゾリズマブ
進行 NSCLC に対する以前の全身療法を受けていない参加者は、1 日目および 6 週間ごとに 1200 μg/kg NT-I7 IM を受け取り、病気が進行するまで 3 週間ごとにアテゾリズマブ IV 1200 mg を受け取ります。
|
1200 μg/kg NT-I7 を 6 週間に 1 回 (Q6W) 筋肉内 (IM) 投与 (サイクル 1 から開始)。
最大35サイクル（約2年）まで治療を継続します。
他の名前：
サイクル 1 から開始して、1200 mg のアテゾリズマブを 3 週間に 1 回 (Q3W) 静脈内 (IV) 投与。
最大35サイクル（約2年）まで治療を継続します。
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：The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
|
The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1. |
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 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：The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
|
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator.
Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
Furthermore, the appearance of one or more new lesions is also considered progression).
Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1.
|
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
|
|
Disease Control Rate (DCR)
時間枠：The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
|
The proportion of subjects with a best overall response of CR, PR or SD, per RECIST 1.1 and iRECIST as determined by the investigator.
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The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
|
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Progression Free Survival (PFS)
時間枠：The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
|
The time from the first study treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator.
Progression is defined using RECIST 1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
Furthermore, the appearance of one or more new lesions is also considered progression.
Under iRECIST, initial progression is classified as immune unconfirmed progressive disease (iUPD).
Progression is confirmed as immune confirmed progressive disease (iCPD) if a subsequent assessment (proportionately 4-8 weeks later) shows a further increase in tumor burden (an additional 5 mm increase in the sum of diameters of target or new lesions, or further progression of non-target lesions) or the appearance of additional new lesions.
|
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
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Overall Survival (OS)
時間枠：Up to 2 years
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The time from first study treatment (Cycle 1, Day 1) to death from any cause.
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Up to 2 years
|
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 (実際)
研究の完了 (実際)
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
- NIT-119
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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