CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 675 target
Drug / intervention
Datopotamab Deruxtecan +2 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • Non-squamous NSCLC confirmed histologically or cytologically
  • Stage IIIB, IIIC, or IV metastatic NSCLC not amenable to curative surgery or definitive chemoradiation
  • Absence of sensitizing EGFR mutations, ALK and ROS1 rearrangements, and no documented local test result for other genomic alterations with approved targeted first-line therapies
  • Tumor PD-L1 expression TC ≥50%
Key exclusion· 12
  • Prior systemic therapy for advanced/metastatic NSCLC
  • Squamous cell, predominantly squamous cell, mixed small cell, or sarcomatoid variant histology
  • History of another primary malignancy within 3 years
  • Active or prior documented autoimmune or inflammatory disorders (with exceptions)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

In the news

1 article

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT06357533
NCT06357533Phase 3RecruitingHigh Momentum

A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)

AstraZeneca·interventional·Posted Apr 10, 2024·Updated Jun 16, 2026

In Brief

A Phase 3 clinical trial evaluating Datopotamab Deruxtecan, Rilvegostomig, and 1 other intervention for Non-Small Cell Lung Cancer. Currently recruiting, targeting 675 participants across 283 sites in 21 countries.

Signals

Enrolling ahead of pace

Detailed Summary

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Brazil, Canada, China, Germany, Hungary, India, Italy, Japan, Poland, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
CollaboratorsDaiichi Sankyo

Timeline

Phase 3Recruiting
202520262027202820292030
First PostedApr 10, 2024
Enrollment StartApr 11, 2024
Primary CompletionDec 28, 2029
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 2.2 years agoPrimary completion in 3.5 years

Arms & Interventions

Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomigexperimental

Participants in the Datopotamab Deruxtecan (Dato-DXd) in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Drug: Datopotamab DeruxtecanDrug: Rilvegostomig
Arm 2: Rilvegostomig Monotherapyexperimental

Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Drug: Rilvegostomig
Arm 3: Pembrolizumab Monotherapyactive_comparator

Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Drug: Pembrolizumab

Interventions

Datopotamab Deruxtecandrug

Datopotamab Deruxtecan IV (intravenous)

Rilvegostomigdrug

Rilvegostomig IV (intravenous)

Pembrolizumabdrug

Pembrolizumab IV (intravenous)