Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06357533 · ClinicalTrials.gov registry record · Phase 3
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 675
- Enrollment target
- 20
- Study locations
NCT06357533: Recruiting Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
NCT06357533 is a Phase 3 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 675 participants, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06357533, a Phase 3 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 675 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of PFS. PFS by investigator will be
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Datopotamab Deruxtecan
- DRUG Rilvegostomig
Study Locations (20)
Florida
- Research Site - Clermont
- Research Site - Gainesville
- Research Site - Miami Beach
- Research Site - Orange City
- Research Site - Orlando
- Research Site - Orlando
- Research Site - West Palm Beach
California
- Research Site - Anaheim
- Research Site - Beverly Hills
- Research Site - Fountain Valley
- Research Site - Newport Beach
Georgia
- Research Site - Atlanta
- Research Site - Atlanta
- Research Site - Atlanta
- Research Site - Atlanta
Arkansas
- Research Site - Little Rock
- Research Site - Springdale
Alaska
- Research Site - Anchorage
Arizona
- Research Site - Tucson
Illinois
- Research Site - Hinsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2024-04-11 |
| Est. Completion | 2029-12-28 |
| Phase | Phase 3 |
What NCT06357533 shows while recruiting
NCT06357533 is an interventional study that assigns participants to a tested intervention. The registered 675 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06357533 names 20 study sites across 7 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06357533 about?
NCT06357533 is a clinical study titled "Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations". 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 (T...
What is the current status of trial NCT06357533?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 675 participants. The study started on 2024-04-11. Estimated completion is 2029-12-28.
What conditions does trial NCT06357533 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06357533?
The interventions under investigation include: Pembrolizumab (DRUG), Datopotamab Deruxtecan (DRUG), Rilvegostomig (DRUG).
Who is sponsoring clinical trial NCT06357533?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06357533 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06357533's enrollment target sits among peer trials
675 46th of 454 higher than 408 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
RECRUITING · Phase 3
-
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
RECRUITING · Phase 3
-
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
RECRUITING · Phase 3
-
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
RECRUITING · Phase 3
-
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
RECRUITING · Phase 3
-
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04788277 · 675 participants
Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC)
- NCT05356234 · 675 participants · NA
Ignite Study of the Jewish Family and Children's Service of the Suncoast, Inc.
- NCT06070870 · 675 participants · NA
Health Education Approach to Lung Screening
- NCT06461897 · 675 participants · Phase 3
A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI