이전에 치료받지 않은 PD-L1 발현, 국소 진행성 또는 전이성 NSCLC에서 아테졸리주맙과 병용한 NT-I7
이전에 치료받지 않은 PD-L1 발현, 국소 진행성 또는 전이성 NSCLC 대상자에서 아테졸리주맙과 병용한 NT-I7의 항종양 효능 및 안전성을 평가하기 위한 다기관, 공개 라벨, 단일군 제2상 연구
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Alabama
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Mobile, Alabama, 미국, 36604
- University of South Alabama
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California
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Cerritos, California, 미국, 90703
- TOI Clinical Research
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Connecticut
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Norwich, Connecticut, 미국, 06360
- Eastern CT Hematology & Oncology Associates
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Florida
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Fort Myers, Florida, 미국, 33916
- Florida Cancer Specialists - South Research Office
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Plantation, Florida, 미국, 33322
- BRCR Medical Center
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St. Petersburg, Florida, 미국, 33705
- Florida Cancer Specialists - North Research Office
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West Palm Beach, Florida, 미국, 33401
- Florida Cancer Specialists - East Research Office
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Georgia
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Athens, Georgia, 미국, 30607
- University Cancer and Blood Center
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Indiana
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Goshen, Indiana, 미국, 46526
- Goshen Center for Cancer Care
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Kentucky
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Louisville, Kentucky, 미국, 40217
- Norton Cancer Institute
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Pikeville, Kentucky, 미국, 41501
- Pikeville Medical Center, Inc.
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Maine
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South Portland, Maine, 미국, 04106
- MaineHealth Cancer Care
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Maryland
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Salisbury, Maryland, 미국, 21801
- TidalHealth Peninsula Regional, Inc.
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New Jersey
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Florham Park, New Jersey, 미국, 07932
- Summit Health Medical Center
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North Carolina
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Greenville, North Carolina, 미국, 27834
- East Carolina University
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Ohio
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Columbus, Ohio, 미국, 43219
- Zangmeister Cancer Center
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Oregon
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Portland, Oregon, 미국, 97239
- OHSU Knight Cancer Institute
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Tennessee
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Chattanooga, Tennessee, 미국, 37404
- Tennessee Oncology - Chattanooga
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Knoxville, Tennessee, 미국, 37916
- Thompson Cancer Survival Center
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Nashville, Tennessee, 미국, 37203
- Tennessee Oncology - Nashville
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Texas
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El Paso, Texas, 미국, 79915
- Renovatio Clinical - El Paso
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The Woodlands, Texas, 미국, 77380
- Renovatio Clinical - The Woodlands
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 조직학적 또는 세포학적으로 확인된 전이성 또는 국소 진행성 NSCLC가 있고 이전에 전신 요법을 받은 적이 없습니다. 국부적으로 진행된 질병을 가진 피험자는 3기 NSCLC를 가져야 하며 외과적 절제 또는 최종 화학방사선 요법의 대상자가 아닙니다.
- PD-L1 22C3 면역조직화학 국소 또는 중앙 검정에 의해 결정된 종양 PD-L1 발현(TPS≥1%).
- 측정 가능한 질병이 있음
- PD-L1 평가를 위한 스크리닝 시 스크리닝 생검(또는 보관 조직) 제공에 동의
- ECOG 0-1
- 적절한 혈액학적 및 말단 장기 기능
제외 기준:
- 선행 전신 항암 요법
- EGFR, ALK, BRAF, ROS, RED 또는 이용 가능한 치료법이 있는 기타 게놈 종양 이상이 있는 NSCLC
- 연구 치료 시작 2주 이내의 이전 방사선 요법
- 알려진 활성 CNS 전이 또는 암종 수막염
- mAb 또는 IV 면역글로불린 제제에 대한 심각한 반응
- 지난 2년간 자가면역질환 병력
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: NT-I7 및 아테졸리주맙
진행성 NSCLC에 대한 사전 전신 요법이 없는 참가자는 질병이 진행될 때까지 1일 및 6주마다 1200 μg/kg NT-I7 IM을 투여받고 3주마다 아테졸리주맙 IV 1200 mg을 투여받습니다.
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주기 1에서 시작하여 6주마다(Q6W) 1회 근육내(IM) 투여된 1200 μg/kg NT-I7.
치료는 최대 35주기(약 2년)까지 계속됩니다.
다른 이름들:
주기 1부터 시작하여 3주마다(Q3W) 1200mg 아테졸리주맙을 정맥내(IV) 투여합니다.
치료는 최대 35주기(약 2년)까지 계속됩니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate (ORR)
기간: 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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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).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Duration of Response (DoR)
기간: 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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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.
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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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Disease Control Rate (DCR)
기간: 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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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)
기간: 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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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.
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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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Overall Survival (OS)
기간: 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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NIT-119
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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