Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

Part of paid clinical trials in Fountain Valley, California.

Sponsor
AstraZeneca
Study ID
NCT06350097
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    Osimertinib 80 mg administered orally once daily (QD).
  • Datopotamab Deruxtecan — DRUG
    Datopotamab Deruxtecan 6 mg/kg administered as an intravenous (i.v.) infusion every 3 weeks (q3w).

Study Details

The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC. Study details include: 1. The study duration will be event-driven, with an estimated duration of approximately 8 years. 2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met. 3. The visit frequency will be every 3 weeks during the treatment period. Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.

Key Dates

Start date
Apr 29, 2024
Status verified
Apr 2026
Primary completion
Mar 21, 2028
Completion
Aug 29, 2031

Study Design

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

Arms

  • Experimental: Arm 1: Osimertinib in combination with Datopotamab Deruxtecan
    Participants in this group will receive osimertinib 80 mg QD as oral tablet with Datopotamab Deruxtecan 6mg/kg as i.v. infusion q3w of Day 1 of every 21-day cycle.
  • Active Comparator: Arm 2: Osimertinib monotherapy
    Participants in this group will receive osimertinib 80 mg QD as oral tablet.

Primary Outcome Measure

To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Progression Free Survival (PFS) by BICR in all randomised participants. [ Time Frame: It is anticipated that it will be performed approximately 3 years after the first participant is randomised. ]

Central Contacts

Locations (36)

FacilityCityStateZIPSite coordinators
Research SiteFountain ValleyCalifornia92708-
Research SiteLos AlamitosCalifornia90720-
Research SiteLos AngelesCalifornia90017-
Research SiteLos AngelesCalifornia90033-
Research SiteOrangeCalifornia92868-
Research SiteSan DiegoCalifornia92123-
Research SiteSanta MonicaCalifornia90404-
Research SiteWalnut CreekCalifornia94598-
Research SiteNew HavenConnecticut06510-
Research SiteWashington D.C.District of Columbia20037-
Research SiteJacksonvilleFlorida32256-
Research SiteOcalaFlorida34474-
Research SiteOrange CityFlorida32763-
Research SiteHonoluluHawaii96819-
Research SiteChicagoIllinois60611-
Research SiteHinsdaleIllinois60521-
Research SiteNorth ChicagoIllinois60064-
Research SiteFort WayneIndiana46845-
Research SiteBethesdaMaryland20817-
Research SiteDetroitMichigan48201-
Research SiteSaint PaulMinnesota55102-
Research SiteBridgetonMissouri63044-
Research SiteSt LouisMissouri63110-
Research SiteLas VegasNevada89169-
Research SiteBrooklynNew York11212-
Research SiteNew YorkNew York10065-
Research SiteDallasTexas75390-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77090-
Research SiteWebsterTexas77598-
Research SiteWoodwayTexas76712-
Research SiteFairfaxVirginia22031-
Research SiteFort BelvoirVirginia22060-
Research SiteMidlothianVirginia23114-
Research SiteSeattleWashington98104-
Research SiteMilwaukeeWisconsin53226-

Find similar trials in Fountain Valley, CA

By condition
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By specialty
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By research site
Research Site· Fountain Valley, CAResearch Site· Los Alamitos, CAResearch Site· Los Angeles, CAResearch Site· Orange, CAResearch Site· San Diego, CAResearch Site· Santa Monica, CA

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