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Non-small Cell Lung CancerPhase 2NCT06731907

A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)

A Phase 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 41 sites in 11 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

Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
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
90 participants
Where
41 sitesin 11 countries
Study dates
30 Mar 2025to 12 Mar 2032
Phase
Phase 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:
  • Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Staging Manual Version 8.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization.
  • Has archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on ART.
  • Participants who are hepatitis B surface antigen (HBsAg) positive 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 treatment randomization.

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Participants with squamous histology are excluded if there is a known tumor-activating epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) or c ros oncogene 1 (ROS1) gene rearrangement.
  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement.
  • Has evidence of any leptomeningeal disease.
Show all 32Show fewer
  • Has known history of, or active, neurologic paraneoplastic syndrome.
  • Has clinically significant corneal disease.
  • Has myocardial infarction within 6 months.
  • Has New York Heart Association (NYHA) Classes 3 or 4 congestive heart failure.
  • Has uncontrolled angina pectoris within 6 months.
  • Has cardiac arrhythmia requiring ongoing antiarrhythmic treatment.
  • Has history of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.
  • Has bradycardia of less than 50 beats per minute (bpm) unless the participant has a pacemaker.
  • Has history of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.
  • Has coronary/peripheral artery bypass graft within 6 months.
  • Has complete left bundle branch block.
  • Has inadequate washout period from prior concomitant therapy as specified in protocol before randomization.
  • Has received prior treatment with a topoisomerase I inhibitor or an anti-HER3 antibody and/or ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
  • 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 protein (anti-PD-L1), or anti- programmed cell death ligand 2 protein (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
  • Has received prior radiotherapy within 2 weeks of randomization, has radiation related toxicity requiring corticosteroids, or has had radiation pneumonitis.
  • 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.
  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy 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 to any of the study interventions and/or any of their excipients.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has active infection requiring systemic therapy.
  • Has concurrent active Hepatitis B and Hepatitis C virus infection.
  • Have not adequately recovered from major surgery or have ongoing surgical complications.

Trial locations and contacts

41 sites in 11 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

41 sites in 11 countries

Israel6 sites, 6 recruiting

  • Rambam Health Care Campus ( Site 0076)

    Haifa, 3109601

    Study Coordinator, +972 47776234

    Recruiting

  • Shaare Zedek Medical Center ( Site 0075)

    Jerusalem, 9103102

    Study Coordinator, +972-2-6555768

    Recruiting

  • Meir Medical Center ( Site 0071)

    Kfar Saba, 4428164

    Study Coordinator, +97297472414

    Recruiting

  • Rabin Medical Center ( Site 0074)

    Petah Tikva, 4941492

    Study Coordinator, +97239378101

    Recruiting

  • Sheba Medical Center ( Site 0070)

    Ramat Gan, 5262000

    Study Coordinator, +97235307096

    Recruiting

  • Sourasky Medical Center ( Site 0077)

    Tel Aviv, 6423906

    Study Coordinator, +972-3-6973082

    Recruiting

Other trials in Israel

Ukraine6 sites, 4 recruiting

  • CNE CC of Oncology Hematol ( Site 0130)

    Cherkasy, Cherkasy Oblast, 18009

    Active, not recruiting

  • Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0136)

    Chernivtsi, Chernivetska Oblast, 58013

    Study Coordinator, 0443344770

    Recruiting

  • CNCE Precarpathian Clinical Oncologic Center ( Site 0131)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Study Coordinator, 380978411455

    Recruiting

  • VISION PARTNER Medical Centre ( Site 0134)

    Kyiv, Kyivska Oblast, 03022

    Completed

  • Shalimov Institute of Surgery and Transplantation ( Site 0135)

    Kyiv, 03126

    Study Coordinator, 0444081800

    Recruiting

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0133)

    Vinnytsia, Vinnytsia Oblast, 21029

    Study Coordinator, 380953105783

    Recruiting

Other trials in Ukraine

United States5 sites, 5 recruiting

  • MedStar Franklin Square Medical Center ( Site 0033)

    Baltimore, Maryland, 21237

    Study Coordinator, 443-777-7147

    Recruiting

  • Sanford Fargo Medical Center ( Site 0039)

    Fargo, North Dakota, 58102

    Study Coordinator, 701-234-2000

    Recruiting

  • University of Kentucky ( Site 0019)

    Lexington, Kentucky, 40536

    Study Coordinator, 859-218-0131

    Recruiting

  • Abramson Cancer Center ( Site 0010)

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 215-220-9703

    Recruiting

  • Sanford Cancer Center ( Site 0038)

    Sioux Falls, South Dakota, 57104

    Study Coordinator, 605-838-8631

    Recruiting

Other trials in United States

Poland4 sites, 3 recruiting

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

    Gdansk, Pomeranian Voivodeship, 80-214

    Study Coordinator, +48585844466

    Recruiting

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

    Koszalin, West Pomeranian Voivodeship, 75-581

    Study Coordinator, +48502204953

    Recruiting

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)

    Poznan, Greater Poland Voivodeship, 60-569

    Active, not recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, 48225463066

    Recruiting

Other trials in Poland

Chile3 sites, 3 recruiting

  • Centro de Estudios Clínicos SAGA ( Site 0162)

    Santiago, Region M. de Santiago, 7500653

    Study Coordinator, 991612199

    Recruiting

  • Fundación Arturo López Pérez ( Site 0161)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 981369487

    Recruiting

  • Bradfordhill ( Site 0160)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 998744662

    Recruiting

Other trials in Chile

Hungary3 sites, 3 recruiting

  • Országos Korányi Pulmonológiai Intézet ( Site 0060)

    Budapest, 1121

    Study Coordinator, +3613913200

    Recruiting

  • Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)

    Győr, Győr-Moson-Sopron, 9024

    Study Coordinator, +3696507900

    Recruiting

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)

    Szolnok, Jász-Nagykun-Szolnok, 5000

    Study Coordinator, +3656503603

    Recruiting

Other trials in Hungary

Italy3 sites, 3 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

    Milan, Lombardy, 20133

    Study Coordinator, 390223902190

    Recruiting

  • IRCCS Ospedale San Raffaele ( Site 0171)

    Milan, 20132

    Study Coordinator, +390223903829

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)

    Roma, 00168

    Study Coordinator, +390630156318

    Recruiting

Other trials in Italy

Spain3 sites, 3 recruiting

  • Hospital Clinic de Barcelona ( Site 0092)

    Barcelona, 08036

    Study Coordinator, 34 932275402

    Recruiting

  • Institut Català d'Oncologia - L'Hospitalet ( Site 0090)

    L'Hospitalet de Llobregat, Barcelona, 08908

    Study Coordinator, 0034932607744

    Recruiting

  • Hospital Universitario Quiron Madrid ( Site 0091)

    Madrid, 28223

    Study Coordinator, +34914521987

    Recruiting

Other trials in Spain

Taiwan3 sites, 3 recruiting

  • Changhua Christian Hospital ( Site 0181)

    Changhua, 50006

    Study Coordinator, +886983901629

    Recruiting

  • Taipei Medical University Hospital ( Site 0180)

    Taipei, 110

    Study Coordinator, +886227372181x7810

    Recruiting

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

    Taoyuan, 33305

    Study Coordinator, +886975368109

    Recruiting

Other trials in Taiwan

Turkey (Türkiye)3 sites, 2 recruiting

  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0141)

    Adana, 01250

    Active, not recruiting

  • Hacettepe Universite Hastaneleri ( Site 0140)

    Ankara, 06410

    Study Coordinator, 00903123054330

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 0142)

    Ankara, 06530

    Study Coordinator, 00905323064615

    Recruiting

Other trials in Turkey (Türkiye)

Greece2 sites, 2 recruiting

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 0204)

    Athens, Attica, 115 27

    Study Coordinator, 0030 2107700220

    Recruiting

  • European Interbalkan Medical Center-Oncology Department ( Site 0205)

    Thessaloniki, 570 01

    Study Coordinator, 0030 2310400213

    Recruiting

Other trials in Greece

About this study

Official title: KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.

Keywords
Lung Neoplasms, Lung Cancer, Pulmonary Neoplasms, Pulmonary Cancer, Non-Small Cell Lung Carcinoma
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • PembrolizumabBiological

    Also called Keytruda®, MK-3475, SCH 900475

    Pembrolizumab 200mg IV Infusion.

  • CarboplatinDrug

    Also called Paraplatin®

    Carboplatin IV infusion AUC5 or 6 mg/mL•min and not exceeding 900mg.

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel 200 mg/m^2 IV infusion.

  • Nab-paclitaxelDrug

    Also called Abraxane

    Nab-paclitaxel 100mg/m^2 IV infusion.

  • PemetrexedDrug

    Also called Alimta

    Pemetrexed 500mg/m^2 IV infusion.

  • HER3-DXdBiological

    Also called patritumab deruxtecan, U3-1402, MK-1022

    HER3-Dxd 5.6mg/kg IV infusion.

Study groups in NCT06731907
Study groupRoleWhat they receive
Pembrolizumab and ChemotherapyActive comparatorPembrolizumab will be administered as a 200mg IV infusion on Day 1 of every three weeks (Q3W) for up to 35 cycles (~ 2 years). The doublet platinum-based chemotherapy treatments used in this substudy are standard-of care regimens for squamous (paclitaxel/Nab-paclitaxel and carboplatin) and nonsquamous (pemetrexed and carboplatin) NSCLC. Pemetrexed is administered as a 500mg/m^2 IV infusion Q3W until discontinuation criterion is met. Nab-paclitaxel will be administered as a 100mg/m^2 IV infusion on Days 1, 8, and 15 Q3W for up to 4 cycles. Paclitaxel will be administered as a 200 mg/m^2 IV infusion on Day 1 Q3W for up to 4 cycles. Carboplatin will be administered as an IV infusion area under the time x concentration curve (AUC) for 4 cycles as per local practice and labels. The dose will be AUC5 or 6 mg/mL•min Q3W and will not exceed 900mg.
Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Pemetrexed
Pembrolizumab and HER3-DXdExperimentalPembrolizumab will be administered as a 200mg IV infusion on Day 1 Q3W for up to 35 cycles (~ 2 years). HER3-Dxd will be administered as 5.6mg/kg IV infusion on Day 1 Q3W until discontinuation criteria is met.
Receives: Biological: Pembrolizumab; Biological: HER3-DXd

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR is defined as a confirmed complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR).

    Measured: Up to ~ 5 years

  2. Number of Participants with Adverse Events (AEs)

    Adverse events are any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

    Measured: Up to ~ 5 years

  3. Number of Participants Discontinuing Study Drug Due to AEs

    Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

    Measured: Up to ~ 2 years

Secondary outcomes (3)

  1. Duration of Response (DOR)

    For participants who demonstrate a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to ~ 5 years

  2. Progression-free Survival (PFS)

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first.

    Measured: Up to ~ 5 years

  3. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to ~ 5 years

Timeline

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

  1. First posted13 Dec 2024
  2. Study start30 Mar 2025
  3. Primary completion12 Mar 2032 (estimated)
  4. Study completion12 Mar 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multi site, rolling-arm study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731907
Sponsor's protocol ID
3475-01G
Other IDs
2024-515772-12-00, U1111-1309-7532, KEYMAKER U01, MK-3475-01G
Status last verified
Oct 2026
First submitted
11 Dec 2024
Last updated
16 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 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 41 sites in 11 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 32 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 16 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 41 sites in Israel, Ukraine, United States, Poland, Chile and 6 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 phase mean?

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?

Overall Response Rate (ORR) (time frame: Up to ~ 5 years). The study lists 3 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 NCT06731907.

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 16 Oct 2026.

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