Study on Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone for First-line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer Without Specific Genetic Changes

Sponsor: Daiichi Sankyo

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05215340

Provider View

This clinical trial is testing whether a combination of the drugs Dato-DXd and pembrolizumab is more effective than pembrolizumab alone in treating advanced or metastatic non-small cell lung cancer (NSCLC) without specific genetic changes.

Patient Parameters

Program Overview

The study aims to find out if using Dato-DXd together with pembrolizumab can improve outcomes like survival and disease progression in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that does not have certain genetic changes. Participants will be randomly assigned to receive either the combination of Dato-DXd and pembrolizumab or pembrolizumab alone. The study includes several phases: a tissue screening period, a screening period, a treatment period, and a follow-up period.

Description

The main goal of this study is to compare how well the combination of Dato-DXd and pembrolizumab works against pembrolizumab alone in terms of how long patients live without the cancer getting worse (Progression Free Survival) or overall survival. This study is for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that does not have specific genetic changes and has high levels of a protein called PD-L1. Participants must not have received any previous treatment for their advanced or metastatic NSCLC.

Participants will be randomly assigned to one of two groups: one group will receive pembrolizumab alone, and the other group will receive both Dato-DXd and pembrolizumab. The study will be conducted in four phases: a tissue screening period to check eligibility, a screening period, a treatment period where the drugs are administered, and a follow-up period to monitor the participants' health and response to treatment.

Eligibility Criteria

Inclusion Criteria

  • Must sign consent forms before any study-specific procedures.
  • Adults aged 18 or older.
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
  • No specific genetic changes in the cancer that can be targeted with other treatments.
  • Provide a tumor sample for testing.
  • High levels of PD-L1 protein in the tumor.
  • Have not received any previous treatment for advanced or metastatic NSCLC.
  • Have measurable disease based on scans.
  • Have good heart function and overall health.
  • Life expectancy of at least 3 months.
  • Adequate bone marrow function.

Exclusion Criteria

  • Have received previous treatment for advanced or metastatic NSCLC.
  • Have received certain types of cancer treatments before.
  • Have untreated or active cancer spread to the brain or spinal cord.
  • Have had recent radiation therapy to the lung.
  • Have another active cancer, except for certain types that are not expected to return.
  • Have a history of lung disease or severe lung problems.
  • Have significant heart disease or uncontrolled high blood pressure.
  • Have severe eye disease.
  • Have received a live vaccine recently.
  • Have an active autoimmune disease or are on immunosuppressive therapy.
  • Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Have an uncontrolled infection.
  • Have had a tissue or organ transplant.
  • Have severe allergies to the study drugs.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.