Phase II Study of Osimertinib Treatment Before and After Chemoradiotherapy in Unresectable Stage III EGFRm Non-Small Cell Lung Cancer (NSCLC)

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06194448

Provider View

This clinical trial is testing the effectiveness and safety of the drug osimertinib when used before and after chemoradiotherapy in adults with Stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery and has specific EGFR mutations.

Patient Parameters

Program Overview

The study aims to see if osimertinib, a targeted therapy, can help control Stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. Patients will receive osimertinib before and after undergoing chemoradiotherapy, which combines chemotherapy and radiation. The study will last about four years, including two years for recruiting participants and two years of follow-up after the last patient starts treatment.

Description

Participants will first take osimertinib for up to 8 weeks, followed by 6 weeks of chemoradiotherapy (CRT), which includes chemotherapy and daily radiation treatments. After CRT, patients will continue taking osimertinib until their cancer progresses or they pass away. During the study, participants will have regular visits every 2 to 4 weeks during the initial osimertinib treatment, every 3 weeks during CRT, and every 12 weeks during the maintenance phase with osimertinib.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and able to give informed consent.
  • Have a confirmed diagnosis of Stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed.
  • Eligible for chemoradiotherapy treatment.
  • Have not received prior chemotherapy, radiation, immunotherapy, or targeted therapy for NSCLC.
  • If previously treated for other stages of NSCLC, must not have received systemic treatment.
  • Have specific EGFR mutations (Ex19del or L858R) confirmed by testing.
  • Have a good performance status, meaning they are fully active or have some restrictions but can still perform light work.
  • Have a life expectancy of more than 12 weeks.
  • Have at least one measurable tumor.
  • Agree to use effective contraception during the study if of childbearing potential.
  • Provide consent for optional genetic research, though participation is not mandatory.

Exclusion Criteria

  • Have small cell lung cancer or a mix of small and non-small cell lung cancer.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis.
  • Have unresolved side effects from previous treatments, except for hair loss or mild nerve damage.
  • Have uncontrolled systemic diseases or infections.
  • Have gastrointestinal issues that prevent taking osimertinib.
  • Have another active cancer, except for certain skin cancers or in situ cancers.
  • Have heart conditions that affect the heart's rhythm or electrical activity.
  • Have inadequate blood cell counts or organ function.
  • Are taking medications that affect the liver enzyme CYP3A4.
  • Have had major surgery or significant injury recently.
  • Are pregnant or breastfeeding.
  • Have a history of allergies to osimertinib or similar drugs.
  • Are involved in the study's planning or conduct.
  • Are unlikely to comply with study procedures.
  • Have participated in this study before or are in another clinical trial.

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