Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Daiichi Sankyo
Study ID
NCT06899126
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Deruxtecan — DRUG
    T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
  • pembrolizumab — DRUG
    pembrolizumab will be administered at a dose of 200 mg IV Q3W
  • Pemetrexed — DRUG
    Pemetrexed will be administered at a dose of 500 mg/m\^2 IV Q3W
  • Platinum Chemotherapy — DRUG
    One of the following two will be administered in Arm B: Cisplatin at a dose of 75 mg/m\^2 IV or carboplatin AUC at a dose of 5 mg/mL/min IV Q3W

Study Details

This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

Key Dates

First listed
Mar 27, 2025
Start date
Oct 24, 2025
Status verified
Jun 2026
Primary completion
Apr 24, 2030
Completion
Nov 24, 2032

Study Design

Enrollment
686 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: T-DXd + Pembrolizumab
    Participants will receive T-DXd plus pembrolizumab
  • Active Comparator: Arm B: Pemetrexed + Platinum Chemotherapy + Pembrolizumab
    Participants will receive Pemetrexed plus platinum chemotherapy (cisplatin or carboplatin) plus pembrolizumab

Primary Outcome Measure

Progression Free Survival by Blinded Independent Central Review [ Time Frame: From date of randomization to the date of radiographic disease progression or death due to any cause, up to approximately 54 months ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Alaska Oncology & Hematology, LLCAnchorageAlaska99508-
Orange Coast Memorial Medical Center Fountain ValleyFountain ValleyCalifornia97208-
California Research InstituteLos AngelesCalifornia90027-
Los Angeles Cancer Network (LACN)Los AngelesCalifornia91204-
Providence Medical FoundationSanta RosaCalifornia95403-
Bay Pines VA Healthcare SystemBay PinesFlorida33744-
Lynn Cancer Institute CenterBoca RatonFlorida33486-
Holy Cross HospitalFort LauderdaleFlorida33308-
Mid-Florida Hematology & Oncology Centers, P.A.Orange CityFlorida33763-
BRCR Global PlantationPlantationFlorida33321-
Hope and Healing Cancer ServicesHinsdaleIllinois60521-
Dana-Farber Cancer InstituteBostonMassachusetts02216-
Logan Health ResearchKalispellMontana59901-
Clinical Research AllianceWestburyNew York11590-
FirstHealth Cancer CenterPinehurstNorth Carolina28374-
Gabrail Cancer CenterCantonOhio44718-
St. Charles Health SystemBendOregon97701-
University of Texas M. D. Anderson Cancer CenterHoustonTexas77030-
Lumi ResearchKingwoodTexas77339-
Summit Cancer Treatment CenterSpokaneWashington99208-

Find similar trials in Anchorage, AK

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Alaska Oncology & Hematology, LLC· Anchorage, AKOrange Coast Memorial Medical Center Fountain Valley· Fountain Valley, CACalifornia Research Institute· Los Angeles, CALos Angeles Cancer Network (LACN)· Los Angeles, CAProvidence Medical Foundation· Santa Rosa, CABay Pines VA Healthcare System· Bay Pines, FL

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