Study on Trastuzumab Deruxtecan as First Treatment for Advanced Non-Small Cell Lung Cancer with HER2 Mutations

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05048797

Provider View

This clinical trial is testing the effectiveness and safety of Trastuzumab Deruxtecan compared to standard treatments for patients with advanced Non-Small Cell Lung Cancer (NSCLC) that has specific HER2 mutations.

Patient Parameters

Program Overview

The DESTINY-Lung04 study is exploring whether Trastuzumab Deruxtecan (T-DXd) is a better first treatment option than the usual care for patients with advanced Non-Small Cell Lung Cancer (NSCLC) that has HER2 mutations in specific areas of the gene (Exon 19 or 20). The study will compare how well patients do on T-DXd versus standard treatments, which include a combination of chemotherapy and immunotherapy. Researchers want to see if T-DXd helps patients live longer or prevents the cancer from worsening, and how it affects their quality of life.

Description

This study is for patients who have been diagnosed with advanced Non-Small Cell Lung Cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body. The cancer must have specific changes in the HER2 gene (Exon 19 or 20 mutations). Participants should not have received any previous treatment aimed at relieving symptoms for advanced cancer.

The main goal is to see if Trastuzumab Deruxtecan can help patients live longer or keep the cancer from getting worse compared to the usual treatment, which includes drugs like cisplatin or carboplatin combined with pembrolizumab and pemetrexed. The study will also look at how the treatment affects patients' quality of life.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Have advanced Non-Small Cell Lung Cancer (NSCLC) that cannot be surgically removed or has spread.
  • Cancer must have specific HER2 mutations in Exon 19 or 20, confirmed by specific tests.
  • Have not received any previous treatment for advanced cancer.
  • Heart function must be at least 50%.
  • Have measurable cancer that can be tracked by scans.
  • Have good organ function, including heart, kidney, and liver.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have tumor tissue available for testing.

Exclusion Criteria

  • Cancer with other targetable mutations like EGFR or ALK.
  • Any untreated brain tumors, even if they are not causing symptoms.
  • Active autoimmune or inflammatory diseases.
  • Recent heart attack within the last 6 months.
  • History of lung inflammation or current lung disease.
  • Severe lung illness that affects daily life.
  • Cannot receive standard chemotherapy or pembrolizumab.

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