임상 레이더 AI | ||
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임상시험 NCT07221474 (INTerpath-13)은(는) 편평 비소세포 폐암에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
A Study of V940/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013) (INTerpath-13) 2상 180
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07221474 (INTerpath-13)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 편평 비소세포 폐암에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 12월 12일에 시작되어 180명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2031년 5월 6일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 30일에 갱신되었습니다.
간단한 개요
Researchers want to know if V940 (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). V940 is designed to help a person's immune system attack their specific cancer.
The goal of this study is to learn if people who receive V940 with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreadin...
더 보기공식 제목
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)
질환명
편평 비소세포 폐암기타 연구 식별자
- INTerpath-13
- V940-013
- V940-013 (기타 식별자) (MSD)
- U1111-1318-2495 (등록 식별자) (UTN)
- 2025-520902-37-00 (등록 식별자) (EU CT)
NCT 번호
실제 연구 시작일
2025-12-12
최신 업데이트 게시
2026-03-30
예상 연구 완료일
2031-05-06
계획된 등록 인원
180
연구종류
중재연구
단계/상
2상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
삼중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적V940 + Pembrolizumab + Chemo Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined with either paclitaxel 200 mg/m\^2 IV infusion Q3W × 2 doses OR nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). V940 1 mg intramuscular (IM) injecti...더 보기 | V940 1 mg Intramuscular (IM) Injection Pembrolizumab 200 mg IV Infusion 카보플라틴 Area Under the Curve (AUC) 6 (mg/mL/min) IV Infusion Paclitaxel 200 mg/m\^2 IV Infusion Nab-paclitaxel 100 mg/m\^2 IV Infusion |
실험적Placebo + Pembrolizumab + Chemo Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined with either paclitaxel 200 mg/m\^2 IV infusion Q3W × 2 doses OR nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). Placebo intramuscular (IM) injection...더 보기 | Pembrolizumab 200 mg IV Infusion 카보플라틴 Area Under the Curve (AUC) 6 (mg/mL/min) IV Infusion Paclitaxel 200 mg/m\^2 IV Infusion Nab-paclitaxel 100 mg/m\^2 IV Infusion 위약 Placebo matched to V940 IM injection |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Progression Free Survival (PFS) | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented. | Up to ~32 months |
Overall Survival (OS) | OS, defined as the time from randomization to death due to any cause. OS will be presented. | Up to ~42 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Overall Response Rate (ORR) | ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented. | Up to ~26 months |
Duration of Response (DOR) | For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. | Up to ~42 months |
Number of Participants who Experience an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented. | Up to ~42 months |
Number of Participants who Discontinue Study Intervention Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study intervention due to an AE will be presented. | Up to ~24 months |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
Inclusion Criteria include, but are not limited to:
- Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
- Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
- Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
- Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Has a life expectancy of at least 3 months
- Has adequate organ function
Exclusion Criteria include, but are not limited to:
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
- Has received prior systemic anticancer therapy for their metastatic NSCLC
- Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
- Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Has received radiation therapy to the lung that is >30 gray within 6 months of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
25 7개국에 임상시험 장소
Kyonggi-do
National Cancer Center ( Site 0504), Goyang-si, Kyonggi-do, 10408, South Korea
Study Coordinator, 연락처, +82319200114
모집중
Seoul National University Bundang Hospital ( Site 0500), Seongnam-si, Kyonggi-do, 13620, South Korea
Study Coordinator, 연락처, +82317877071
모집중
North Chungcheong
Chungbuk National University Hospital-Internal medicine ( Site 0501), Cheongju-si, North Chungcheong, 28644, South Korea
Study Coordinator, 연락처, 043-269-6015
모집중
Asan Medical Center ( Site 0503), Seoul, 05505, South Korea
Study Coordinator, 연락처, +82230103215
모집중
Samsung Medical Center ( Site 0502), Seoul, 06351, South Korea
Study Coordinator, 연락처, +82234101132
모집중
New Jersey
Valley Health Systems - Ridgewood Campus ( Site 0010), Paramus, New Jersey, 07652, United States
Study Coordinator, 연락처, 201-634-5578
모집중
Ohio
Cleveland Clinic - Ohio ( Site 0016), Cleveland, Ohio, 44195, United States
Study Coordinator, 연락처, 216-445-7855
모집중
Tennessee
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000), Nashville, Tennessee, 37203, United States
Study Coordinator, 연락처, 615-961-9469
모집중
Virginia
Virginia Cancer Specialists ( Site 0003), Fairfax, Virginia, 22031, United States
Study Coordinator, 연락처, 730-280-5390
모집중
Buenos Aires
Hospital Italiano de Buenos Aires ( Site 0200), Ciudad Autonoma de Buenos Aires., Buenos Aires, C1199ABB, Argentina
Study Coordinator, 연락처, +541149590497
모집중
Instituto Alexander Fleming ( Site 0201), Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Study Coordinator, 연락처, +541132218956
모집중
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205), Mar del Plata, Buenos Aires, B7600FZO, Argentina
Study Coordinator, 연락처, +5492235937663
모집중
Buenos Aires F.D.
Clinica Adventista Belgrano ( Site 0206), Caba., Buenos Aires F.D., C1430EGF, Argentina
Study Coordinator, 연락처, +5491140141500
모집중
Santa Fe Province
Fundacion Estudios Clinicos ( Site 0207), Rosario, Santa Fe Province, S2000DSV, Argentina
Study Coordinator, 연락처, +5493413168137
모집중
Sanatorio Parque ( Site 0203), Rosario, Santa Fe Province, S2000DSV, Argentina
Study Coordinator, 연락처, +543874044942
모집중
New South Wales
Westmead Hospital ( Site 0400), Westmead, New South Wales, 2145, Australia
Study Coordinator, 연락처, +61298455555
모집중
Western Australia
One Clinical Research ( Site 0402), Nedlands, Western Australia, 6009, Australia
Study Coordinator, 연락처, +6186279 9466
모집중
Region M. de Santiago
Centro de Estudios Clínicos SAGA ( Site 0307), Santiago, Region M. de Santiago, 7500653, Chile
Study Coordinator, 연락처, +56991612199
모집중
FALP ( Site 0300), Santiago, Region M. de Santiago, 7500921, Chile
Study Coordinator, 연락처, 56224205098
모집중
Bradfordhill ( Site 0301), Santiago, Region M. de Santiago, 8420383, Chile
Study Coordinator, 연락처, +56 2 29490970
모집중
Bradford Hill Norte ( Site 0308), Antofagasta, 1240000, Chile
Study Coordinator, 연락처, 56442023631
모집중
National Cheng Kung University Hospital ( Site 0601), Tainan, 70403, Taiwan
Study Coordinator, 연락처, +88662353535
모집중
Mackay Memorial Hospital ( Site 0604), Taipei, 104, Taiwan
Study Coordinator, 연락처, +886225433535
모집중
Chang Gung Medical Foundation-Linkou Branch ( Site 0605), Taoyuan District, 33305, Taiwan
Study Coordinator, 연락처, +88633281200
모집중
Hacettepe Universitesi Tıp Fakultesi ( Site 1400), Ankara, 06230, Turkey (Türkiye)
Study Coordinator, 연락처, +905436067759
모집중