Comparing 11 approaches for non-small-cell lung carcinoma
Official title: 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)
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)
- Phase 1
- 11 groups
- One site, in Edmonton
- Recruiting
Interventions (10)
- Biological therapy
Pembrolizumab
IV infusion
- Medication
Carboplatin
IV infusion
- Medication
Paclitaxel
IV infusion
- Medication
Pemetrexed
IV infusion
- Biological therapy
Vibostolimab
IV infusion
- Biological therapy
Boserolimab
IV infusion
- Biological therapy
MK-4830
IV infusion
- Biological therapy
MK-0482
IV Infusion
- Biological therapy
Ifinatamab Deruxtecan (I-DXd)
IV infusion
- Biological therapy
HER3-DXd
IV Infusion
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Cross Cancer Institute ( Site 0291)
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for32 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +The main inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → include but are not limited to the following:
- +Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
- +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 periodScreeningThe checks done before joining, to see whether a study fits.Read more → 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
- +Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy
Exclusion
- −Previously had a severe hypersensitivity reaction to treatment with monoclonal antibodies (including pembrolizumab) and/or any of their excipients
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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
- −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
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → may significantly alter the absorption or metabolism of oral medications
- −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
- −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
- −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
- −Has had an allogenic tissue/solid organ transplant
- −Has had major surgery \<3 weeks before the first dose of study treatment
- −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 any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (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)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 11 groups in this study.
Group A receives Pembrolizumab, Vibostolimab, Carboplatin and Paclitaxel.
Registry label: A: Part A: Pembrolizumab+Vibostolimab+Carboplatin + Paclitaxel
Group B receives Pembrolizumab, Vibostolimab, Carboplatin and Pemetrexed.
Registry label: B: Part A: Pembrolizumab+Vibostolimab+Carboplatin + Pemetrexed
Group C receives Pembrolizumab, Boserolimab, Carboplatin and Paclitaxel.
Registry label: C: Part A: Pembrolizumab+Boserolimab+Carboplatin+Paclitaxel
Group D receives Pembrolizumab, Boserolimab, Carboplatin and Pemetrexed.
Registry label: D: Part A: Pembrolizumab+Boserolimab+Carboplatin+Pemetrexed
Group E receives Pembrolizumab, MK-4830, Carboplatin and Paclitaxel.
Registry label: E: Part A: Pembrolizumab+MK-4830+Carboplatin+Paclitaxel
Group F receives Pembrolizumab, MK-4830, Carboplatin and Pemetrexed.
Registry label: F: Part A: Pembrolizumab+MK-4830+Carboplatin+Pemetrexed
Groups G and H receive Pembrolizumab, MK-0482 and Carboplatin.
Registry label: G: Part A: Pembrolizumab+MK-0482+Carboplatin+Paclitaxel · H: Part A: Pembrolizumab+MK-0482+Carboplatin+Pemetrexed
Group I receives Pembrolizumab, together with one or more of: Ifinatamab Deruxtecan (I-DXd).
Registry label: I: Part B: Pembrolizumab + I-DXd
Group J receives Pembrolizumab and Carboplatin, together with one or more of: Ifinatamab Deruxtecan (I-DXd).
Registry label: J: Part B: Pembrolizumab + Carboplatin + I-DXd
Group K receives Pembrolizumab, Carboplatin and HER3-DXd.
Registry label: K: Part B: Pembrolizumab + Carboplatin + HER3-DXd
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 450 people.
The study is currently expected to finish around October 2032.
The main measurement is taken over: Up to approximately 24 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) — measured over Up to approximately 24 months.
Part B: Number of Participants Who Experience One or More Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to approximately 27 months.
Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE) — measured over Up to approximately 24 months.
Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) — measured over Up to approximately 3 Weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04165070 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PembrolizumabBiological
IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About CarboplatinDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PaclitaxelDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PemetrexedDrug
IV infusion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About VibostolimabBiological
IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About BoserolimabBiological
IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About MK-4830Biological
IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About MK-0482Biological
IV Infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Ifinatamab Deruxtecan (I-DXd)Biological
IV infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About HER3-DXdBiological
IV Infusion
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to approximately 24 months.
The study as a whole is currently expected to finish around 2032-10-13.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 450 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Edmonton, Alberta, Canada; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Other Sites (1)
Laura and Isaac Perlmutter Cancer Center ( Site 0034)
New York, New York, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.