Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

May 21, 2026 updated by: Merck Sharp & Dohme LLC

KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)

Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body.

Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC.

Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.

The main goals of this study are to learn about:

  • The cancer response to the study treatments compared to chemotherapy
  • The safety of the study treatments and if people tolerate them

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500653
        • Recruiting
        • Centro de Estudios Clínicos SAGA ( Site 0161)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991612199
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 0160)
        • Contact:
          • Study Coordinator
          • Phone Number: 56227128000
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 0162)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +86023-65311341
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Provincial Cancer Hospital ( Site 0310)
        • Contact:
          • Study Coordinator
          • Phone Number: 0591-83660063
    • Guangxi
      • Nanning, Guangxi, China, 530201
        • Recruiting
        • Guangxi Medical University Cancer Hospital ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: 0771-5323175
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital ( Site 0311)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613837174273
    • Jiangsu
      • Nanjing, Jiangsu, China, 210031
        • Recruiting
        • Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309)
        • Contact:
          • Study Coordinator
          • Phone Number: +8602165115006
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-65115006
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • Shanghai Chest Hospital ( Site 0308)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-63846590
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charite-Universitaetsmedizin Berlin ( Site 0191)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 30 450 553 044
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • UniversitaetsklInikum Tuebingen ( Site 0192)
        • Contact:
          • Study Coordinator
          • Phone Number: +4970712982795
  • Greece
      • Thessaloniki, Greece, 570 01
        • Recruiting
        • European Interbalkan Medical Center-Oncology Department ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2310400213
    • Attica
      • Athens, Attica, Greece, 115 27
        • Recruiting
        • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2107700220
      • Athens, Attica, Greece, 106 76
        • Recruiting
        • EVANGELISMOS S.A ( Site 0206)
        • Contact:
          • Study Coordinator
          • Phone Number: +302132041631
  • Hungary
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Recruiting
        • Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063)
        • Contact:
          • Study Coordinator
          • Phone Number: +3676516700
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Recruiting
        • Petz Aladar Egyetemi Oktato Korhaz ( Site 0062)
        • Contact:
          • Study Coordinator
          • Phone Number: +3696507900
    • Jász-Nagykun-Szolnok
      • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
        • Recruiting
        • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061)
        • Contact:
          • Study Coordinator
          • Phone Number: +3656503603
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 0076)
        • Contact:
          • Study Coordinator
          • Phone Number: +972 47776234
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 0075)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-2-6555768
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center ( Site 0071)
        • Contact:
          • Study Coordinator
          • Phone Number: +97297472414
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 0074)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239378101
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 0070)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235307032
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 0077)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-3-6973082
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi ( Site 0173)
        • Contact:
          • Study Coordinator
          • Phone Number: +393209225506
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele. ( Site 0171)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223903829
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
        • Contact:
          • Study Coordinator
          • Phone Number: 390223902190
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630156318
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-569
        • Recruiting
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153)
        • Contact:
          • Study Coordinator
          • Phone Number: +48616654242
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225463066
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
        • Contact:
          • Study Coordinator
          • Phone Number: +48585844466
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152)
        • Contact:
          • Study Coordinator
          • Phone Number: +48943488930
  • Spain
      • Barcelona, Spain, 08008
        • Recruiting
        • Hospital Clinic de Barcelona ( Site 0092)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 932275402
      • Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quiron Madrid ( Site 0091)
        • Contact:
          • Study Coordinator
          • Phone Number: 34914521987
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet ( Site 0090)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034932607744
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Recruiting
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141)
        • Contact:
          • Study Coordinator
          • Phone Number: +905353067506
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 305 43 36
      • Istanbul, Turkey (Türkiye), 34098
        • Recruiting
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144)
        • Contact:
          • Study Coordinator
          • Phone Number: +902124143000
  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • Recruiting
        • University of Kentucky Chandler Medical Center ( Site 0019)
        • Contact:
          • Study Coordinator
          • Phone Number: 859-257-1000
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • MedStar Franklin Square Medical Center ( Site 0033)
        • Contact:
          • Study Coordinator
          • Phone Number: 443-777-7147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
  • Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (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
  • Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
  • Has uncontrolled or significant cardiovascular disorder
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy
  • Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
  • Has clinically significant corneal disease
  • Has previously received docetaxel as monotherapy or in combination with other therapies
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Evidence of any leptomeningeal disease
  • Has one or more of the following indicators of interstitial lung disease (ILD)/pneumonitis: any history of ILD/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current diagnosis of ILD, clinical or radiographic suspicion of ILD
  • Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
  • Active infection requiring systemic therapy
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Known history of, or active, neurologic paraneoplastic syndrome
  • History of allogeneic tissue/solid organ transplant
  • Has not adequately recovered from major surgery or have ongoing surgical complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Raludotatug deruxtecan (R-DXD)
Participants receive 5.6 mg/kg of R-DXD, every 3 weeks (Q3W) (Day 1 of every 21-day cycle) via intravenous (IV) infusion until progressive disease (PD) or discontinuation.
Biological: R-DXD
IV Infusion
Other Names:
  • DS-6000a
  • Raludotatug deruxtecan
  • MK-5909
Drug: Rescue Medications
Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines.
Experimental: Arm 2: Infinatamab deruxtecan (I-DXD) High Dose
Participants receive 12 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
Biological: I-DXD
IV Infusion
Other Names:
  • DS-7300a
  • MK-2400
  • Ifinatamab deruxtecan
Drug: Rescue Medications
Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines.
Experimental: Arm 3: I-DXD Low Dose
Participants receive 8 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
Biological: I-DXD
IV Infusion
Other Names:
  • DS-7300a
  • MK-2400
  • Ifinatamab deruxtecan
Drug: Rescue Medications
Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines.
Active Comparator: Arm 4: Docetaxel
Participants receive 75 mg/m^2 of Docetaxel, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation.
Drug: Docetaxel
IV Infusion
Other Names:
  • Taxotere®
Drug: Rescue Medication
Participants are premedicated with corticosteroids per approved product label and following institutional standards or local guidelines.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 81 months
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) as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be assessed by Blinded Independent Central Review (BICR). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 81 months
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to approximately 81 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to approximately 81 months
Number of participants who discontinue study intervention due to an AE
Time Frame: Up to approximately 81 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 81 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 81 months
OS is defined as time from randomization to death due to any cause.
Up to approximately 81 months
Duration of Response (DOR)
Time Frame: Up to approximately 81 months
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or 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 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 approximately 81 months
Progression-free Survival (PFS)
Time Frame: Up to approximately 81 months
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by (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 BICR will be presented.
Up to approximately 81 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Daiichi Sankyo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3475-01I
  • MK-3475-01I (Other Identifier: MSD)
  • U1111-1314-2392 (Registry Identifier: UTN)
  • KEYMAKER-01I (Other Identifier: MSD)
  • 2024-518839-11-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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