Phase III Study of Dato-DXd with Durvalumab and Carboplatin for Advanced Non-Small Cell Lung Cancer (NSCLC) Without Specific Genetic Changes

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05687266

Provider View

This clinical trial is testing a new combination of drugs, Dato-DXd, durvalumab, and carboplatin, to see if they work better than the current standard treatment for adults with advanced non-small cell lung cancer (NSCLC) that does not have certain genetic changes.

Patient Parameters

Program Overview

This study is a Phase III trial, which means it is testing the effectiveness and safety of a new treatment on a larger scale. It involves comparing a new combination of drugs—Dato-DXd, durvalumab, and carboplatin—with the standard treatment of pembrolizumab and chemotherapy. The trial is for adults with advanced stages of non-small cell lung cancer (NSCLC) that do not have specific genetic changes, like EGFR mutations or ALK and ROS1 rearrangements. The goal is to see if the new combination can help patients live longer without the cancer getting worse and improve overall survival.

Description

In this study, participants with advanced non-small cell lung cancer (NSCLC) that does not have certain genetic changes will be randomly assigned to one of two treatment groups. One group will receive a new combination of drugs: Dato-DXd, durvalumab, and carboplatin. The other group will receive the current standard treatment, which includes pembrolizumab and chemotherapy based on the type of lung cancer.

The main goals of the study are to find out if the new combination of Dato-DXd, durvalumab, and carboplatin is better at stopping the cancer from getting worse and helping patients live longer compared to the standard treatment. The study will focus on patients whose cancer cells have a specific marker called TROP2. Researchers will measure how long patients live without the cancer progressing and their overall survival rates to determine the effectiveness of the new treatment.

Eligibility Criteria

Inclusion:

  • Participants ≥ 18 years at screening
  • Histologically or cytologically documented NSCLC that at the time of randomisation is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation or Stage IV metastatic disease
  • Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved and available therapies (actionable genomic alterations).

Testing is not required for tumors with squamous histology, with exceptions.

  • ECOG PS of 0 or 1
  • Archival tumour tissue
  • Has adequate bone marrow reserve and organ function within 7 days before randomization

Exclusion:

  • Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC
  • History of another primary malignancy with exceptions
  • Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade ≤ 1 or baseline, with exceptions.
  • Spinal cord compression or clinically or radiologically active brain metastases
  • History of leptomeningeal carcinomatosis.
  • Known active or uncontrolled hepatitis B or C virus infection.
  • Uncontrolled or suspected infection requiring IV antibiotics, antivirals, or antifungals.
  • Clinically significant corneal disease
  • History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

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