KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
A legfontosabb adatok
- Ki végzi
- Merck Sharp & Dohme LLC
- Hol
- Changhua, Taipei és Taoyuan (Tajvan)Mind a 3 helyszín megnézéseMég 9 másik országban, 45 helyszínen
- Azonosító
- NCT04165070
- EU 2023-506932-33-00
- EudraCT 2020-001626-56
- U1111-1294-6474
- Állapot
- Toboroz
- Fázis
- 1/2. fázis
- Résztvevők
- 450 fő, tervezett
- Kezdés
- 2019. dec. 19.
- Várható befejezés
- 2032. okt. 13.
- A vizsgálat típusa
- Beavatkozással járó, 11 csoport
- A vizsgált kezelések
- Pembrolizumab
- Carboplatin
- Paclitaxel
- Pemetrexed
- Vibostolimab
- Boserolimab
- MK-4830
- MK-0482
- Ifinatamab Deruxtecan (I-DXd)
- HER3-DXd
- A regiszteradat frissítve
- 2026. október 29.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan felnőtteket keres, akiknek IV. stádiumú laphámsejtes vagy nem laphámsejtes nem kissejtes tüdőrákjuk van, és az áttétes daganatukkal még nem kaptak kezelést.
- Életkor
- 18 éves vagy idősebb
- Nem
- Nemtől függetlenül csatlakozhat bárki
- A betegség stádiuma
- IV. stádiumú laphámsejtes vagy nem laphámsejtes nem kissejtes tüdőrák (NSCLC), szövet- vagy sejtvizsgálattal igazolva
- Korábbi kezelés
- Az áttétes nem kissejtes tüdőrákra nem kapott korábban szisztémás kezelést. A nem laphámsejtes daganatnál nem kaphat engedélyezett célzott terápiát.
A részvétel fő kizáró okai
- Kissejtes tüdőrák
- Aktív agyi vagy gerincvelői (központi idegrendszeri) áttét vagy carcinomás agyhártyagyulladás
- Aktív autoimmun betegség, amely az elmúlt 2 évben szisztémás kezelést igényelt
- Korábbi vagy jelenlegi tüdőgyulladás (pneumonitis), amely szteroidot igényelt
- Korábbi szilárd szerv- vagy szövetátültetés másik személytől
A regiszter feltételei, szó szerint
Mind a 32 feltétel megnézéseKevesebb
Ki vehet részt
- The main inclusion criteria include but are not limited to the following:
- Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
- Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy
- Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation
- Has not received prior systemic treatment for their metastatic NSCLC
- Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for Part B
Ki nem vehet részt
- 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 before the first dose of study treatment
- Has a known history of Hepatitis B (HPV) or known active Hepatitis C virus infection. Hepatitis B surface antigen (HBsAg) positive is eligible if on HBV antiviral therapy for at least 4 weeks and HBV viral load is undetectable prior to randomization
- Has had major surgery <3 weeks before the first dose of study treatment
- Is expected to require any other form of antineoplastic therapy while on study
- Is getting chemotherapy and has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, or peritoneal carcinomatosis
- Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease
- Has received prior radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study treatment
- Has received a live vaccine within 30 days before the first dose of study treatment. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed
- Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE)
- Has had chemotherapy or biological cancer therapy within 4 weeks before the first dose of study treatment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks before the first dose of study treatment (including participants who had previous immunomodulatory therapy with residual irAEs)
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study treatment
- Previously had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and/or any of their excipients
- Has had an allogenic tissue/solid organ transplant
- Has a diagnosis of small cell lung cancer
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, or New York Heart Association Class III or IV congestive heart failure
- Has a known history of human immunodeficiency virus (HIV) infection. Well-controlled HIV with anti-retroviral therapy (ART) is not excluded
- Has a history or current evidence of a gastrointestinal (GI) condition (e.g. inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications
- The main exclusion criteria include but are not limited to the following:
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has preexisting neuropathy that is moderate in intensity
- Is unable or unwilling to take folic acid or vitamin B12 supplementation, for participants who will receive pemetrexed
- Has a known sensitivity to any component of carboplatin, paclitaxel, pemetrexed or any of their excipients
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- Has your cancer spread to the brain?
- Has your cancer spread to the lining around the brain or spinal cord?
Helyszínek itt: Tajvan
Még 9 másik országban, 45 helyszínen
- Changhua Christian Hospital (Site 0181)Changhua, TajvanContact: Study CoordinatorRésztvevőt keres
- Taipei Medical University Hospital (Site 0180)Taipei, TajvanContact: Study CoordinatorRésztvevőt keres
- Chang Gung Medical Foundation-Linkou Branch (Site 0182)Taoyuan, TajvanContact: Study CoordinatorRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC.
A teljes eredeti leírásKevesebb
This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
A vizsgálat 11 csoportja
- Part A: Pembrolizumab+Vibostolimab+Carboplatin + PaclitaxelA vizsgált kezelés
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg intravenously (IV) PLUS vibostolimab IV PLUS carboplatin Area Under the Concentration-Time Curve (AUC) 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Kezelés: Pembrolizumab, Carboplatin, Paclitaxel és Vibostolimab
- Part A: Pembrolizumab+Vibostolimab+Carboplatin + PemetrexedA vizsgált kezelés
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Kezelés: Pembrolizumab, Carboplatin, Pemetrexed és Vibostolimab
- Part A: Pembrolizumab+Boserolimab+Carboplatin+PaclitaxelA vizsgált kezelés
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).
Kezelés: Pembrolizumab, Carboplatin, Paclitaxel és Boserolimab
- Part A: Pembrolizumab+Boserolimab+Carboplatin+PemetrexedA vizsgált kezelés
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS pemetrexed 500 mg/m\^2 IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).
Kezelés: Pembrolizumab, Carboplatin, Pemetrexed és Boserolimab
- Part A: Pembrolizumab+MK-4830+Carboplatin+PaclitaxelA vizsgált kezelés
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Kezelés: Pembrolizumab, Carboplatin, Paclitaxel és MK-4830
- Part A: Pembrolizumab+MK-4830+Carboplatin+PemetrexedA vizsgált kezelés
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Kezelés: Pembrolizumab, Carboplatin, Pemetrexed és MK-4830
- Part A: Pembrolizumab+MK-0482+Carboplatin+PaclitaxelA vizsgált kezelés
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Kezelés: Pembrolizumab, Carboplatin és MK-0482
- Part A: Pembrolizumab+MK-0482+Carboplatin+PemetrexedA vizsgált kezelés
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Kezelés: Pembrolizumab, Carboplatin és MK-0482
- Part B: Pembrolizumab + I-DXdA vizsgált kezelés
On Day 1 of each 3-week cycle, participants with squamous and nonsquamous NSCLC will receive pembrolizumab 200 mg IV for up to 2 years, PLUS I-DXd in escalating doses until progressive disease or toxicity.
Kezelés: Pembrolizumab és Ifinatamab Deruxtecan (I-DXd)
- Part B: Pembrolizumab + Carboplatin + I-DXdA vizsgált kezelés
On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS I-DXd IV in escalating doses until PD or toxicity.
Kezelés: Pembrolizumab, Carboplatin és Ifinatamab Deruxtecan (I-DXd)
- Part B: Pembrolizumab + Carboplatin + HER3-DXdA vizsgált kezelés
On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS HER3-DXd IV in escalating doses until PD or toxicity.
Kezelés: Pembrolizumab, Carboplatin és HER3-DXd
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
- Hivatalos cím
- KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
- Illeszkedési kérdések
- Forrás: NCT04165070: ki vehet részt
- A regiszteradat frissítve
- 2026. október 29.