비소세포폐암(NSCLC)에 대한 화학방사선 요법과 후속 강화 면역요법을 병용한 JNJ-90301900에 대한 연구 (CONVERGE)
국소적으로 진행되고 절제 불가능한 3기 NSCLC에서 화학방사선 요법과 뒤이어 Durvalumab을 병용한 JNJ-90301900의 2상, 무작위배정, 공개 라벨, 활성 대조 연구
The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Study Contact
- 전화번호: 844-434-4210
- 이메일: Participate-In-This-Study1@its.jnj.com
연구 장소
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Amsterdam, 네덜란드, 1066 CX
- 모병
- Antoni van Leeuwenhoek
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Nijmegen, 네덜란드, 6525 GA
- 모병
- Radboud Umcn
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California
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La Jolla, California, 미국, 92037
- 모병
- Moores Cancer Center at UC San Diego Health
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Connecticut
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Farmington, Connecticut, 미국, 06030
- 완전한
- University of Connecticut Health Center
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New Haven, Connecticut, 미국, 06519
- 모병
- Yale University
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Florida
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Miami, Florida, 미국, 33136
- 모병
- University of Miami
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Orlando, Florida, 미국, 32806
- 모병
- Orlando Health Cancer Institute
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Georgia
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Atlanta, Georgia, 미국, 30306
- 모병
- Emory University Winship Cancer Institute
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- 모병
- Beth Israel Deaconess Medical Center
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Missouri
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St Louis, Missouri, 미국, 63130
- 모병
- Washington University in St Louis
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New Jersey
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New Brunswick, New Jersey, 미국, 08901
- 모병
- Rutgers Cancer Institute of New Jersey
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New York
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New York, New York, 미국, 10016
- 모병
- NYU Langone Health
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New York, New York, 미국, 10065
- 모병
- Memorial Sloan Kettering Cancer Center
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North Carolina
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Chapel Hill, North Carolina, 미국, 27514
- 모병
- University of North Carolina at Chapel Hill
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Pinehurst, North Carolina, 미국, 28374
- 모병
- FirstHealth of the Carolinas
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Ohio
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Cleveland, Ohio, 미국, 44106
- 모병
- University Hospitals Cleveland Medical Center
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Oregon
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Portland, Oregon, 미국, 97239
- 모병
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 모병
- University of Pennsylvania
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Texas
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Houston, Texas, 미국, 77030
- 모병
- MD Anderson Cancer Center
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Vermont
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Burlington, Vermont, 미국, 05401
- 모병
- University of Vermont Medical Center
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Barretos, 브라질, 14784 400
- 모병
- Fundacao Pio XII
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São Paulo, 브라질, 05651 901
- 모병
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, 브라질, 01308 050
- 모병
- Sociedade Beneficente de Senhoras Hospital Sirio Libanes
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Madrid, 스페인, 28041
- 모병
- Hosp. Univ. 12 de Octubre
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Pamplona, 스페인, 31008
- 모병
- Clinica Univ. de Navarra
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Santiago de Compostela, 스페인, 15706
- 모병
- Hosp. Clinico Univ. de Santiago
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Valencia, 스페인, 46026
- 모병
- Hosp. Univ. I Politecni La Fe
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London, 영국, NW1 2BU
- 모병
- University College London Hospitals
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Dongguan, 중국, 523109
- 모병
- Dongguan People s Hospital
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Guangzhou, 중국, 510080
- 모병
- The First Affiliated Hospital Sun Yat sen University
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Jinan, 중국, 250117
- 모병
- The Affiliated Cancer Hospital of Shandong First Medical University
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Istanbul, 터키 (Türkiye), 34899
- 모병
- Marmara University Pendik Training Hospital
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Sakarya, 터키 (Türkiye), 54100
- 모병
- Sakarya University Training and Research Hospital
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Brest, 프랑스, 29200
- 모병
- Hopital De La Cavale Blanche
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Marseille, 프랑스, 13015
- 모병
- Hopital Nord Marseille
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Paris, 프랑스, 75248
- 모병
- Institut Curie
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Paris, 프랑스, 75020
- 모병
- Hopital Tenon
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Rouen, 프랑스, 76000
- 모병
- CHU Rouen Hopital Charles Nicolle
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Villejuif, 프랑스, 94805
- 모병
- Gustave Roussy
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Camperdown, 호주, 2050
- 모병
- Chris O'Brien Lifehouse
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Herston, 호주, 4029
- 모병
- Royal Brisbane and Women's Hospital
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Nedlands, 호주, 6009
- 모병
- Sir Charles Gairdner Hospital
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North Ryde, 호주, 2109
- 모병
- Macquarie University
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Parkville, 호주, 3050
- 모병
- Royal Melbourne Hospital
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Shatin, 홍콩
- 모병
- Prince of Wales Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Must be a candidate for standard of care (SOC) treatment of non small cell lung cancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation durvalumab treatment as determined by the investigator and per local guidelines at screening
- Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization
- Have locally advanced unresectable stage III NSCLC according to the eighth edition lung cancer stage classification
- Have at least 1 target lesion (primary lung lesion or involved lymph node[s]) per RECIST version 1.1 that is amenable to intratumoral and/or intranodal injection and intensity modulated radiation therapy (IMRT) as determined by the investigator at screening
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
Exclusion Criteria:
- Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic immunosuppression
- Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, clinically significant ventricular arrhythmias or heart failure New York heart association functional classification class III to IV
- Another concurrent or prior primary malignancy within the last 36 months at informed consent
- Known allergies, hypersensitivity, or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab
- History of coagulation disorders, including: (a) Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for JNJ-90301900 injection procedures, (b) Major thromboembolic events (for example, pulmonary embolism, cerebrovascular accident) within 3 months of enrollment or randomization
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Part 1: Cohort A and Cohort B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume [GTV] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure. |
JNJ-90301900 will be injected intratumorally and/or intranodally. Durvalumab will be administered as intravenous (IV) infusion as cIT. Radiation by intensity modulated radiation therapy (IMRT) will be administered. Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy. Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy. |
|
실험적: Part 2: Arm A and Arm B
Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900. |
JNJ-90301900 will be injected intratumorally and/or intranodally. Durvalumab will be administered as intravenous (IV) infusion as cIT. Radiation by intensity modulated radiation therapy (IMRT) will be administered. Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy. Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy. |
|
활성 비교기: Part 2: Arm C: (Control treatment)
Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900. |
Durvalumab will be administered as intravenous (IV) infusion as cIT. Radiation by intensity modulated radiation therapy (IMRT) will be administered. Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy. Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment
기간: Up to 2 Years and 2 months
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ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 using ICR assessments. |
Up to 2 Years and 2 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Objective Response Rate (ORR) Post-cCRT and Pre-cIT
기간: Up to 12 Weeks
|
Objective response rate is defined as percentage of participants who achieve CR or PR, post-concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) and pre-consolidation immunotherapy (cIT) based on investigator's assessment according to RECIST v1.1. |
Up to 12 Weeks
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Disease Control Rate (DCR) Post-cCRT and Pre-cIT
기간: Up to 12 Weeks
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DCR is defined as percentage of participants who achieve CR, PR and stable disease post-cCRT and pre-cIT based on investigator's assessment according to RECIST v1.1. |
Up to 12 Weeks
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Objective Response Rate (ORR) as Assessed by the Investigator
기간: Up to 2 Years and 2 months
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ORR is defined as the percentage of participants who have a best response of CR or PR using RECIST v1.1 as assessed by the investigator. |
Up to 2 Years and 2 months
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Progression Free Survival (PFS)
기간: Up to 2 Years and 2 months
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PFS is defined as the time from the enrollment/randomization until disease progression or death due to any cause according to RECIST v1.1. |
Up to 2 Years and 2 months
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Duration of Response (DoR)
기간: Up to 2 Years and 2 months
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DoR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first. |
Up to 2 Years and 2 months
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Time to Locoregional Failure (LRF)
기간: Up to 2 Years and 2 months
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Time to LRF is defined as the time from enrollment/randomization to the first LRF using ICR assessments. |
Up to 2 Years and 2 months
|
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Time to Distant Failure (DF)
기간: Up to 2 Years and 2 months
|
Time to DF is defined as the time from enrollment/randomization to the first DF using ICR assessments. |
Up to 2 Years and 2 months
|
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Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment
기간: Up to 2 Years and 2 months
|
TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose of study treatment received plus 30 days or prior to the start of subsequent anticancer therapy (non-durvalumab), whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent anticancer therapy, or any AE that is considered treatment-related regardless of the start date of the event. TEAEs related to JNJ-90301900 injection procedure, JNJ-90301900, RT, ChT, or cIT will be reported. |
Up to 2 Years and 2 months
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Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities
기간: Up to 2 Years and 2 months
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Participants with laboratory parameters, physical examination, vital signs including ECOG performance status abnormalities will be reported. |
Up to 2 Years and 2 months
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 90301900NSC2001
- 90301900NSC2001 (기타 식별자: Janssen Research & Development, LLC)
- 2024-518276-32-00 (레지스트리 식별자: EUCT number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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