Clin2
NCT06350097Likely a fitRecruiting

Osimertinib with or without datopotamab deruxtecan for first-line EGFR-mutant lung cancer

Non-small Cell Lung Cancer

Treatments studied

Part of Cancer, Lungs & breathing clinical trials.

This trial tests a combination of two targeted drugs (osimertinib plus datopotamab deruxtecan) against osimertinib alone in patients with a specific type of lung cancer called EGFR-mutant non-small cell lung cancer. It is for people with advanced or recurrent disease who have not yet received systemic treatment.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
582 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You must be 18 years old or older.
  • You must have non-small cell lung cancer that is not of the squamous type (mixed types allowed if the main part is adenocarcinoma).
  • Your cancer must be stage IIIB, IIIC, or IV, or have returned (recurrent) and cannot be treated with surgery or radiation.
  • You must not have previously received EGFR inhibitor drugs or other systemic treatments for advanced stages of your lung cancer.
  • Your tumor must have a specific EGFR mutation (either Ex19del or L858R).
  • You must provide a tumor tissue sample for testing.
  • You must have a good performance status (able to carry out daily activities).
  • You must have at least one measurable tumor that has not been previously treated with radiation.
  • Your bone marrow and organ function must be adequate.
  • You must not have serious or uncontrolled medical conditions, including active bleeding.
  • You must not have a history of another primary cancer.
  • You must not have spinal cord compression or unstable brain metastases.
  • You must not have clinically significant corneal disease.
  • You must not have active or uncontrolled hepatitis B or C infection.
  • You must not have a history of interstitial lung disease (ILD) or drug-induced ILD, or suspected ILD that cannot be ruled out by imaging.
  • You must not have severely reduced lung function due to other lung diseases.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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