재발성(비소세포) 폐암 치료를 위한 단일 제제 또는 Pembrolizumab과의 병용 GEN1046의 안전성 및 효능 연구
면역 체크포인트 억제제를 사용한 표준 치료 요법으로 치료한 후 재발성/불응성 전이성 비소세포폐암 대상자에서 단일 요법 및 병용 Pembrolizumab 요법으로 GEN1046의 2상, 다기관, 무작위, 공개 라벨 시험
The goal of this clinical trial is to compare the safety and efficacy (how well the drug works) of acasunlimab (also known as GEN1046) when it is used alone (monotherapy) versus when it is combined with a cancer drug (pembrolizumab) for participants with relapsed/refractory (disease has returned after treatment or did not respond to treatment) non-small cell lung cancer (NSCLC; the most common type of lung cancer).
This trial has 2 parts. The purpose of the first part is to find out if the combination of acasunlimab and pembrolizumab is safe and to find out the best doses to use. The purpose of the second part is to give acasunlimab and pembrolizumab to more participants to evaluate efficacy. In the second part of the trial, participants will be randomized to participate in 1 of the 3 arms of the trial. Randomized means that the participant will be randomly assigned to a treatment arm based on chance; no one chooses their treatment arm.
Participants will receive either acasunlimab alone (100 followed by 500 mg into the vein) or acasunlimab with pembrolizumab (200 or 400 mg into the vein) once every 3 or 6 weeks, depending on which arm the participant is randomized into. All participants will receive active drug; no one will receive placebo.
Trial details include:
- The average trial duration for an individual participant will be about 10 months.
- The average treatment duration for an individual participant will be about 6 months.
- The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드
- VU University Medical Center
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Amsterdam, 네덜란드
- Netherlands Cancer Institute
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Leiden, 네덜란드
- Leids Universitair Medisch Centrum
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Rotterdam, 네덜란드
- Erasmus MC
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Hanover, 독일
- Med.Hochschule Hannover Klinik für Pneumologie
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Hessen, 독일
- Universitatsklinik Giessen und Marburg Standort Giessen
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Immenhausen, 독일
- LKI Lungenfachklinik Immenhausen
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Regensburg, 독일
- Department of Internal Medicine II
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California
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Santa Rosa, California, 미국, 95403
- St. Joseph Heritage Healthcare
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Florida
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Fort Myers, Florida, 미국, 33901
- Florida Cancer Specialists - FCS South
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St. Petersburg, Florida, 미국, 33705
- Florida Cancer Center
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Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford Cancer Institute
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Grand Rapids, Michigan, 미국, 49503
- Cancer & Hematology Centers of Western Michigan CHCWM P.C.
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin
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Barcelona, 스페인
- Hospital Universitari Vall dHebron
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Madrid, 스페인
- Hospital Universitario 12 de Octubre
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Madrid, 스페인
- MD Anderson Cancer Center
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Madrid, 스페인
- Clinica Universidad de Navarra CUN
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Madrid, 스페인
- Hospital Universitario Fundacion Jimenez Diaz
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Málaga, 스페인
- Hospital Universitario Virgen de la Victoria
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Pamplona, 스페인
- Clinica Universidad de Navarra
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Valencia, 스페인
- Fundacion Instituto Valenciano de Oncologia
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Cheltenham, 영국
- Cheltenham General Hospital
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Manchester, 영국
- The Christie Hospital
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Catania, 이탈리아
- Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco
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Milan, 이탈리아
- IRCCS Istituto Europeo di Oncologia
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Naples, 이탈리아
- UOC Oncoematologia AOU L.Vanvitelli
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Palermo, 이탈리아
- La Maddalena SPA
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Roma, 이탈리아
- IFO Regina Elena
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Lisbon, 포르투갈
- Centro Clinico Champalimaud
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Porto, 포르투갈
- Centro Hospitalar Universitário do Porto - Hospital de Santo Antonio
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Olsztyn, 폴란드
- Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc
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Warsaw, 폴란드
- Maria Sklodowska-Curie National Research Institute of Oncology
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Bordeaux, 프랑스
- Institut Bergonie
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Brest, 프랑스
- Hopital Morvan CHU de Brest
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Rouen, 프랑스
- Hopital Charles Nicolle Chu Rouen
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Saint-Mandé, 프랑스
- Hopital dInstruction Des Armees Begin
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Strasbourg, 프랑스
- Institut de Cancerologie Strasbourg Europe (ICANS)
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Suresnes, 프랑스
- Hôpital Foch
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Villejuif, 프랑스
- Gustave Roussy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- Have signed an informed consent form (ICF)
- Be at least 18 years of age.
- Have histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 mAb for metastatic disease
- Have a tumor PD-L1 expression result available prior to first treatment demonstrating PD-L1 expression in ≥1% of tumor cells as assessed by a central or local laboratory during screening.
- Have measurable disease per RECIST v1.1.
- Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
- Have life expectancy of at least 3 months.
- Have adequate organ and bone marrow function as defined in the protocol.
Key Exclusion Criteria:
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Documentation of known EGFR, KRAS, RET, ROS1, BRAF mutations, NTRK gene infusions, RET arrangement, ALK gene rearrangements, high-level MET amplification, or METex 14 skipping. Note: Subjects harboring such mutations, gene rearrangements or amplifications may be enrolled in the trial, if subjects have received prior approved targeted therapy for such mutations, the subject may still be eligible for this trial.
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Treatment with an anti-cancer agent within 28 days prior to acasunlimab administration.
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Any investigational agent (including investigational vaccines).
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Radiotherapy within 14 days prior to first dose of acasunlimab. Note: palliative radiotherapy will be allowed for local pain control under certain conditions.
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Chronic systemic immunosuppressive corticosteroid doses, ie, prednisone >10 mg daily or a cumulative dose >150 mg prednisone within 14 days before the first acasunlimab administration.
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Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
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Subject has contraindications to the use of pembrolizumab per local prescribing information.
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Subject has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis (interstitial lung disease).
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Ongoing or active infection requiring intravenous treatment with anti-infective therapy or any ongoing systemic inflammatory condition requiring further diagnostic work-up or management during screening.
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Symptomatic congestive heart failure (grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia.
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Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management.
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Ongoing or recent (within 6 months) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs.
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Subject has a known history of any of the following:
- Grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment.
- Myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade.
- Liver disease (eg, alcoholic hepatitis or non-alcoholic steatohepatitis, drug-related or autoimmune hepatitis, or evidence of hepatic cirrhosis).
- Organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of acasunlimab.
- Grade 3 or higher allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Arm A
Treatment with acasunlimab once every 21 days for the first 2 cycles and then every 42 days in subsequent cycles |
Acasunlimab will be administered intravenously (IV)
다른 이름들:
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실험적: Arm B
Treatment with acasunlimab + pembrolizumab once every 21 days |
Acasunlimab will be administered intravenously (IV)
다른 이름들:
Pembrolizumab will be administered IV
다른 이름들:
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실험적: Arm C
Treatment with acasunlimab + pembrolizumab once every 42 days |
Acasunlimab will be administered intravenously (IV)
다른 이름들:
Pembrolizumab will be administered IV
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: From first treatment to approximately 27 weeks after last subject's first dose
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ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per RECIST v1.1 |
From first treatment to approximately 27 weeks after last subject's first dose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Duration of response (DOR)
기간: From onset date of response until disease progression/death/lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first (an expected average of 6 months)
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DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v. 1.1 or death from any cause, whichever occurs first. |
From onset date of response until disease progression/death/lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first (an expected average of 6 months)
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Time to response (TTR)
기간: From first treatment to date of onset of initial response (CR or PR) as per RECIST v.1.1 (an expected average of 6 months)
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TTR will be measured as the time from first treatment to onset of initial response (CR or PR) as per RECIST v.1.1 |
From first treatment to date of onset of initial response (CR or PR) as per RECIST v.1.1 (an expected average of 6 months)
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Progression-free survival (PFS)
기간: From first treatment to first documented progression or death due to any cause (an expected average of 6 months)
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PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v.1.1 or until death from any cause, whichever occurs first |
From first treatment to first documented progression or death due to any cause (an expected average of 6 months)
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Overall survival (OS)
기간: From first treatment to date of death (assessed up to 3 years after the last participant's first dose in the trial)
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Defined as time to death from of any cause |
From first treatment to date of death (assessed up to 3 years after the last participant's first dose in the trial)
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Incidence and severity of adverse events (AEs) and laboratory abnormalities
기간: Throughout the trial until end of safety follow-up period (60 days or 90 days after last dose)
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Incidence of treatment-emergent AEs as assessed by CTCAE v5.0. Laboratory parameters graded by CTCAE v5.0 |
Throughout the trial until end of safety follow-up period (60 days or 90 days after last dose)
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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
- GCT1046-04
- 2021-001928-17 (EudraCT 번호)
- 1004314 (기타 식별자: IRAS ID; UK Research Summaries Database)
- NL-OMON54259 (레지스트리 식별자: CCMO (The Netherlands))
- 2024-513770-22-00 (기타 식별자: EU Trial (CTIS) Number)
- RECF-005102 (레지스트리 식별자: National Institute of Cancer France)
- 15582 (레지스트리 식별자: Portugal RNET)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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