A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
AstraZeneca
Study ID
NCT06417814
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Metastatic Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Dato-DXd — DRUG
    Dato-DXd will be administered as IV infusion.
  • Osimertinib — DRUG
    Osimertinib will be administered orally.
  • Pemetrexed — DRUG
    Pemetrexed will be administered as IV infusion.
  • Carboplatin — DRUG
    Carboplatin will be administered as IV infusion.
  • Cisplatin — DRUG
    Cisplatin will be administered as IV infusion.

Study Details

This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).

Key Dates

First listed
May 16, 2024
Start date
Oct 4, 2024
Status verified
Oct 2026
Primary completion
Jan 11, 2027
Completion
Sep 27, 2028

Study Design

Enrollment
768 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Dato-DXd + Osimertinib Combination Therapy
    Participants will receive Dato-DXd 6 milligrams per kilogram (mg/kg) as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of every 21-day cycle, and osimertinib 80 milligrams (mg) once daily (QD) orally, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.
  • Experimental: Group 2: Dato-DXd Monotherapy
    Participants will receive Dato-DXd 6 mg/kg as IV infusion Q3W on Day 1 of every 21-day cycle, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.
  • Experimental: Group 3: Platinum-based Doublet Chemotherapy
    Participants will receive pemetrexed 500 milligrams per meter square (mg/m2) in combination with carboplatin (AUC5) or cisplatin 75 mg/m2 as IV infusion Q3W for 4 cycles followed by pemetrexed maintenance 500 mg/m2 as IV infusion Q3W, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or another discontinuation criterion is met.

Primary Outcome Measure

Progression free Survival (PFS) [ Time Frame: Up to 2.5 years ]

Locations (9)

FacilityCityStateZIPSite coordinators
Research SiteFayettevilleArkansas72703-
Research SiteFountain ValleyCalifornia92708-
Research SiteSan DiegoCalifornia92123-
Research SiteJacksonvilleFlorida32256-
Research SiteKansas CityMissouri64132-
Research SiteNew YorkNew York10065-
Research SiteMaumeeOhio43537-
Research SitePittsburghPennsylvania15232-
Research SiteNashvilleTennessee37203-

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