ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase III • Oncology • NCT05215340.
- What is being tested: Datopotamab deruxtecan (Dato-DXd), a novel antibody-drug conjugate, combined with the PD-L1 inhibitor pembrolizumab versus pembrolizumab monotherapy as first-line treatment for advanced/metastatic NSCLC without actionable genomic alterations.
- Patient eligibility overview: Adults with advanced or metastatic non-squamous NSCLC who lack actionable genomic alterations (such as EGFR mutations or ALK rearrangements) and are treatment-Phase IIIïve, representing a significant proportion of NSCLC patients with limited targeted therapy options.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study. * Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures. * Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent. * Histologically documented non-squamous NSCLC that meets all of the following criteria (Note: Subjects with squamous histology were eligible prior to Protocol Version 5.0. After Protocol Version 5.0, subjects with squamous histology are not eligible. Subjects with mixed histology, including those with a squamous component, remain eligible the study even after Protocol Version 5.0): 1. Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study. 2. Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations (AGAs) based on analysis of tumor tissue. If test results…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.