Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial Description

The primary objective of the study is to compare the efficacy of Dato-DXd and pembrolizumab with pembrolizumab alone in terms of either Progression Free Survival (PFS) or Overall Survival (OS) for participants with advanced or metastatic NSCLC without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression (tumor proportion score; TPS ≥50%) and who have not previously received systemic therapy for advanced or metastatic NSCLC. Eligible participants will be randomized in a 1:1 ratio to the control arm (pembrolizumab alone) or the experimental arm (Dato-DXd and pembrolizumab). The study will be divided into 4 periods: Tissue Screening Period, Screening Period, Treatment Period, and Follow-up Period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05215340
Study type Interventional
Source Daiichi Sankyo
Contact (US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Phone 908-992-6400
Email CTRinfo@dsi.com
Status Recruiting
Phase Phase 3
Start date March 4, 2022
Completion date April 30, 2028

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04965090 - A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC) Phase 2
Recruiting NCT06060613 - Safety and Efficacy of OBX-115 in Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04884282 - Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) Phase 2
Recruiting NCT05236608 - A Study to Evaluate the Combination of Nivolumab With ADG106 in Metastatic NSCLC Phase 1/Phase 2
Recruiting NCT04614103 - Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer Phase 2
Withdrawn NCT06068153 - AMG510 (Sotorasib) Plus Lenvatinib as Second-line Treatment in Patients With KRASG12C Mutant, Metastatic NSCLC Phase 2
Not yet recruiting NCT06066138 - A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing Phase 1
Recruiting NCT05429320 - A Study of Local Ablative Therapy (LAT) in People With Non-Small Cell Lung Cancer (NSCLC) Phase 2
Recruiting NCT05478538 - Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform
Completed NCT01773109 - Etirinotecan Pegol (NKTR-102) in NSCLC Phase 2
Recruiting NCT04743505 - Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Recruiting NCT05111197 - Local Ablative Stereotactic Radiotherapy for Residual Hypermetabolic Lesion in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Long-term Responders to Immunotherapy Phase 3
Recruiting NCT05555732 - Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) Phase 3
Recruiting NCT05676749 - C-TIL051 in Non-Small Cell Lung Cancer Phase 1
Not yet recruiting NCT05566223 - CISH Inactivated TILs in the Treatment of NSCLC Phase 1/Phase 2
Terminated NCT01060514 - Pazopanib + Vinorelbine in Non Small Cell Lung Cancer (NSCLC) and Breast Cancer Phase 1
Completed NCT05167500 - Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment
Recruiting NCT05259319 - Study Evaluating the Safety and the Efficacy of Combination of Atezolizumab, Tiragolumab and and Stereotactic Body Radiation Therapy in Patients With Oligometastatic Multiorgan (IMMUNOs-SBRT) Phase 1
Enrolling by invitation NCT04697446 - External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC
Completed NCT04511533 - Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations Phase 4