Phase III Study of Dato-DXd and Rilvegostomig for Advanced Non-squamous NSCLC with High PD-L1 Levels

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06357533

Provider View

This clinical trial is testing the effectiveness and safety of a new drug combination, Dato-DXd with Rilvegostomig, compared to the standard treatment pembrolizumab, for patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has high levels of PD-L1 and no specific genetic changes that can be targeted with other treatments.

Patient Parameters

Program Overview

The study aims to find out if the combination of Dato-DXd and Rilvegostomig, or Rilvegostomig alone, is more effective and safe compared to pembrolizumab alone for treating patients with advanced non-squamous non-small cell lung cancer (NSCLC) that shows high PD-L1 expression and lacks certain genetic changes that can be treated with other drugs.

Description

This Phase III study is open-label, meaning both the researchers and participants know which treatment is being given. It compares the new drug combination of Datopotamab Deruxtecan (Dato-DXd) with Rilvegostomig, or Rilvegostomig alone, against the standard treatment pembrolizumab. The trial is for patients with advanced non-squamous NSCLC that has high PD-L1 levels (TC ≥ 50%) and no genetic changes that can be targeted with other approved treatments. Participants will be randomly assigned to one of the treatment groups to evaluate which is more effective as a first-line treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-squamous non-small cell lung cancer (NSCLC).
  • Cancer is at an advanced stage (IIIB, IIIC, or IV) and cannot be treated with surgery or radiation.
  • No specific genetic changes like EGFR mutations or ALK and ROS1 rearrangements that can be treated with other drugs.
  • Must provide a tumor sample to check PD-L1 and TROP2 levels and other markers.
  • Known PD-L1 levels of TC ≥ 50%.
  • At least one measurable tumor that has not been treated with radiation.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate blood and organ function before starting the study treatment.

Exclusion Criteria

  • Have received previous treatment for advanced/metastatic NSCLC.
  • Have squamous cell lung cancer or mixed types like small cell lung cancer.
  • Have had another cancer within the last 3 years.
  • Have active or past autoimmune or inflammatory disorders, with some exceptions.
  • Have severe or uncontrolled diseases, including bleeding, infections, or lung diseases like ILD/pneumonitis.
  • Have fluid buildup in the body that cannot be drained.
  • Have lung issues that required steroids or have current lung problems.
  • Have untreated spinal cord compression or brain metastases unless stable and not needing treatment.
  • Have a history of cancer spread to the brain lining.
  • Have significant eye diseases.
  • Have active infections like TB, hepatitis, or uncontrolled HIV.
  • Have a history of immune system disorders.

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