AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 1/2NCT04165070

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 Phase 1/2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 47 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Pembrolizumab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
47 sitesin 10 countries
Study dates
19 Dec 2019to 13 Oct 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has a diagnosis of small cell lung cancer
  • 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 additional malignancy that is progressing or has required active treatment within the past 2 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years
Show all 26Show fewer
  • 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 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
  • 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
  • Is getting chemotherapy and has clinically active diverticulitis, intra-abdominal abscess, GI obstruction, or peritoneal carcinomatosis
  • Has preexisting neuropathy that is moderate in intensity
  • Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease
  • 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
  • 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

Trial locations and contacts

47 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

47 sites in 10 countries

United States18 sites, 6 recruiting

  • MedStar Franklin Square Medical Center ( Site 0033)

    Baltimore, Maryland, 21237

    Completed

  • Massachusetts General Hospital ( Site 0003)

    Boston, Massachusetts, 02114

    Completed

  • Dana Farber Cancer Institute ( Site 0002)

    Boston, Massachusetts, 02215

    Completed

  • Cleveland Clinic Main ( Site 0006)

    Cleveland, Ohio, 44195

    Completed

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015)

    Columbus, Ohio, 43210

    Study Coordinator, 614-366-0233

    Recruiting

  • City of Hope ( Site 0014)

    Duarte, California, 91010

    Completed

  • Sanford Fargo Medical Center ( Site 0039)

    Fargo, North Dakota, 58102

    Study Coordinator, 701-234-2000

    Recruiting

  • Banner MD Anderson Cancer Center ( Site 0001)

    Gilbert, Arizona, 85234

    Completed

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)

    Hackensack, New Jersey, 07601

    Completed

  • The University of Texas MD Anderson Cancer Center ( Site 0009)

    Houston, Texas, 77030

    Study Coordinator, 844-465-0138

    Recruiting

  • Dartmouth Hitchcock Medical Center ( Site 0016)

    Lebanon, New Hampshire, 03766

    Study Coordinator, 603-650-4428

    Recruiting

  • University of Kentucky Markey Cancer Center ( Site 0019)

    Lexington, Kentucky, 40536-0293

    Completed

  • Laura and Isaac Perlmutter Cancer Center ( Site 0034)

    New York, New York, 10016

    Completed

  • Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)

    Omaha, Nebraska, 68130

    Completed

  • Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 215-220-9703

    Recruiting

  • UCSF Medical Center at Mission Bay ( Site 0007)

    San Francisco, California, 94158

    Completed

  • Sanford Cancer Center ( Site 0038)

    Sioux Falls, South Dakota, 57104

    Study Coordinator, 605-328-8000

    Recruiting

  • Georgetown University ( Site 0036)

    Washington D.C., District of Columbia, 20007

    Completed

Other trials in United States

Israel7 sites, 2 recruiting

  • Soroka Medical Center ( Site 0072)

    Beersheba, 8457108

    Completed

  • Rambam Health Care Campus-Oncology ( Site 0076)

    Haifa, 3109601

    Completed

  • Shaare Zedek Medical Center ( Site 0075)

    Jerusalem, 9103102

    Study Coordinator, +97225645203

    Recruiting

  • Meir Medical Center ( Site 0071)

    Kfar Saba, 4428132

    Completed

  • Rabin Medical Center ( Site 0074)

    Petah Tikva, 4941492

    Completed

  • Chaim Sheba Medical Center ( Site 0070)

    Ramat Gan, 5262000

    Study Coordinator, +97235307096

    Recruiting

  • Sourasky Medical Center ( Site 0077)

    Tel Aviv, 6423906

    Completed

Other trials in Israel

Ukraine4 sites, 4 recruiting

  • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)

    Cherkasy, Cherkasy Oblast, 18009

    Study Coordinator, +380472370123

    Recruiting

  • Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0460)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Study Coordinator, +380978411455

    Recruiting

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)

    Rivne, Rivne Oblast, 33010

    Study Coordinator, +380362633075

    Recruiting

  • Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)

    Uzhhorod, Zakarpattia Oblast, 88017

    Study Coordinator, +380506847086

    Recruiting

Other trials in Ukraine

Hungary3 sites

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

    Budapest, 1121

    Completed

  • Petz Aladar Megyei Oktato Korhaz ( Site 0062)

    Győr, Győr-Moson-Sopron, 9024

    Completed

  • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)

    Szolnok, Jász-Nagykun-Szolnok, 5004

    Completed

Other trials in Hungary

Italy3 sites

  • Azienda Ospedaliera Universitaria Careggi ( Site 0173)

    Florence, Firenze, 50134

    Completed

  • IRCCS Ospedale San Raffaele ( Site 0171)

    Milan, 20132

    Completed

  • Policlinico Gemelli di Roma ( Site 0174)

    Roma, 00168

    Completed

Other trials in Italy

Poland3 sites

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

    Gdansk, Pomeranian Voivodeship, 80-952

    Completed

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)

    Koszalin, West Pomeranian Voivodeship, 75-581

    Active, not recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

    Warsaw, Masovian Voivodeship, 02-781

    Completed

Other trials in Poland

South Korea3 sites

  • Seoul National University Bundang Hospital ( Site 0081)

    Seongnam-si, Kyonggi-do, 13620

    Completed

  • Severance Hospital ( Site 0080)

    Seoul, 03722

    Completed

  • Samsung Medical Center ( Site 0082)

    Seoul, 06351

    Completed

Other trials in South Korea

Taiwan3 sites, 3 recruiting

  • Changhua Christian Hospital ( Site 0181)

    Changhua, 50006

    Study Coordinator, +886983901629

    Recruiting

  • Taipei Medical University Hospital ( Site 0180)

    Taipei, 110301

    Study Coordinator, +886227372181x7810

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0182)

    Taoyuan, 33305

    Study Coordinator, +886975368109

    Recruiting

Other trials in Taiwan

Spain2 sites

  • ICO L Hospitalet ( Site 0090)

    L'Hospitalet de Llobregat, Barcelona, 08907

    Completed

  • Hospital Universitario Quiron Madrid ( Site 0091)

    Madrid, 28223

    Completed

Other trials in Spain

Canada1 site, 1 recruiting

  • Cross Cancer Institute ( Site 0291)

    Edmonton, Alberta, T6G 1Z2

    Study Coordinator, 780-432-8771

    Recruiting

Other trials in Canada

About this study

Official title: 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)

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.

This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

Read the detailed description

The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798

Being tested
Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed, Vibostolimab
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475, SCH 900475, KEYTRUDA®

    IV infusion

  • CarboplatinDrug

    Also called PARAPLATIN®

    IV infusion

  • PaclitaxelDrug

    Also called ABRAXANE®

    IV infusion

  • PemetrexedDrug

    Also called ALIMTA®

    IV infusion

  • VibostolimabBiological

    Also called MK-7684

    IV infusion

  • BoserolimabBiological

    Also called MK-5890

    IV infusion

  • MK-4830Biological

    IV infusion

  • MK-0482Biological

    IV Infusion

  • Ifinatamab Deruxtecan (I-DXd)Biological

    Also called DS-7300a, MK-2400

    IV infusion

  • HER3-DXdBiological

    Also called U3-1402, MK-1022

    IV Infusion

Study groups in NCT04165070
Study groupRoleWhat they receive
Part A: Pembrolizumab+Vibostolimab+Carboplatin + PaclitaxelExperimentalOn 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).
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Biological: Vibostolimab
Part A: Pembrolizumab+Vibostolimab+Carboplatin + PemetrexedExperimentalOn 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).
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Biological: Vibostolimab
Part A: Pembrolizumab+Boserolimab+Carboplatin+PaclitaxelExperimentalOn 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).
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Biological: Boserolimab
Part A: Pembrolizumab+Boserolimab+Carboplatin+PemetrexedExperimentalOn 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).
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Biological: Boserolimab
Part A: Pembrolizumab+MK-4830+Carboplatin+PaclitaxelExperimentalOn 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).
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Biological: MK-4830
Part A: Pembrolizumab+MK-4830+Carboplatin+PemetrexedExperimentalOn 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).
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Biological: MK-4830
Part A: Pembrolizumab+MK-0482+Carboplatin+PaclitaxelExperimentalOn 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).
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Biological: MK-0482
Part A: Pembrolizumab+MK-0482+Carboplatin+PemetrexedExperimentalOn 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).
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Biological: MK-0482
Part B: Pembrolizumab + I-DXdExperimentalOn 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.
Receives: Biological: Pembrolizumab; Biological: Ifinatamab Deruxtecan (I-DXd)
Part B: Pembrolizumab + Carboplatin + I-DXdExperimentalOn 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.
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Biological: Ifinatamab Deruxtecan (I-DXd)
Part B: Pembrolizumab + Carboplatin + HER3-DXdExperimentalOn 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.
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Biological: HER3-DXd

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR will be reported.

    Measured: Up to approximately 24 months

  2. Part B: Number of Participants Who Experience One or More Adverse Events (AEs)

    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 reported.

    Measured: Up to approximately 27 months

  3. Part B: Number of Participants Who Discontinue Study Intervention Due to 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 discontinue study intervention due to an AE will be reported.

    Measured: Up to approximately 24 months

  4. Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

    A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT per CTCAE 5.0 will be reported.

    Measured: Up to approximately 3 Weeks

Secondary outcomes (11)

  1. Part A: Progression-Free Survival (PFS) According to RECIST 1.1

    PFS is defined as the time from first dose of study treatment until either the earliest date of documented progressive disease (PD) or death due to any cause, whichever occurs first. Per 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 will be reported.

    Measured: Up to approximately 24 months

  2. Part A: Number of Participants Who Experience One or More AEs

    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 reported.

    Measured: Up to approximately 27 months

  3. Part A: Number of Participants Who Discontinue Study Treatment 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 reported.

    Measured: Up to approximately 24 months

  4. Part B: ORR per RECIST 1.1 as assessed by blinded independent central review (BICR)

    ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR will be reported.

    Measured: Up to approximately 24 months

  5. Part B: Duration of Response (DOR) per RECIST 1.1 as assessed by BICR

    For participants who show confirmed CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR will be reported.

    Measured: Up to approximately 24 months

  6. Part B: Cmax of I-DXd

    Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of I-DXd.

    Measured: At designated time points up to approximately 2 years

  7. Part B: Cmax of HER3-DXd

    Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of HER3-DXd.

    Measured: At designated time points up to approximately 2 years

  8. Part B: Cmax of pembrolizumab

    Cmax is the maximum concentration of the drug observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of pembrolizumab.

    Measured: At designated time points up to approximately 2 years

  9. Part B: Ctrough of I-DXd

    Ctrough is defined as the lowest observed concentration of drug in plasma at the end of the dosing interval. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough of I-DXd.

    Measured: At designated time points up to approximately 2 years

  10. Part B: Ctrough of HER3-DXd

    Ctrough is defined as the lowest observed concentration of drug in plasma at the end of the dosing interval. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough of HER3-DXd.

    Measured: At designated time points up to approximately 2 years

  11. Part B: Ctrough of pembrolizumab

    Ctrough is defined as the lowest observed concentration of drug in serum at the end of the dosing interval. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough of pembrolizumab.

    Measured: At designated time points up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2019
  2. Study start19 Dec 2019
  3. Primary completion13 Feb 2032 (estimated)
  4. Study completion13 Oct 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Only participants in Part A will be randomized.
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04165070
Sponsor's protocol ID
3475-01A
Other IDs
MK-3475-01A, KEYMAKER-U01A, 2023-506932-33-00, U1111-1294-6474, 2020-001626-56, 2023
Status last verified
Oct 2026
First submitted
14 Nov 2019
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC at 47 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Israel, Ukraine, Hungary, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Up to approximately 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04165070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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