Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

Conditions

• Metastatic Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Datopotamab Deruxtecan — DRUG
  Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
• Pembrolizumab — DRUG
  Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Study Details

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.

Key Dates

Start date

Mar 4, 2022

Status verified

May 2026

Primary completion

Feb 29, 2028

Completion

Apr 30, 2028

Study Design

Enrollment

740 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)
  Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.
• Active Comparator: Pembrolizumb
  Participants will be randomized to receive 200 mg pembrolizumab.

Primary Outcome Measure

Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab [ Time Frame: From randomization until disease progression or death (whichever occurs first), up to approximately 44 months ]

Central Contacts

• (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
  908-992-6400
  [email protected]
• (Asia Sites) Daiichi Sankyo Contact for Clinical Trial Informat
  +81-3-6225-1111(M-F 9-5 JST)
  [email protected]

Locations (36)

Find similar trials in Chandler, AZ

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