Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC

Launched by ASTRAZENECA · Apr 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has certain genetic changes (EGFR mutations). The study is exploring how effective the combination of a medication called Osimertinib and chemotherapy is when given as the first treatment for patients who cannot have surgery to remove their cancer. The goal is to understand how this treatment works in real-life situations, particularly in terms of how long patients can live without their cancer getting worse and how long they live overall.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of advanced NSCLC with specific genetic mutations. They should also be in decent health, meaning they can carry out daily activities with little to no assistance. Patients who have had other treatments for lung cancer in the past may also qualify, as long as they are currently free from disease progression. If you join the trial, you will receive the new combination treatment and be monitored closely by doctors to assess your health and the treatment's effectiveness. This trial is currently recruiting participants, so there may be opportunities for patients who meet the criteria to get involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed.
• • Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation.
• • EGFR sensitive mutation-positive (Ex19del and/or 21 L858R)
• • WHO performance status of 0 to 2 at screening with no clinically significant deterioration in the previous 2 weeks.
• • Patients who receive Osimertinib plus chemotherapy as first-line treatment based on physician's medical assessment are eligible (For patients who received prior chemotherapy alone/Osimertinib monotherapy/Osimertinib plus chemotherapy as first-line therapy ahead of enrolment, they are diseases progression-free at the time of enrolment and the duration of prior therapy ≤3 months).
• • Patients with asymptomatic CNS metastases or patients who have completed definitive therapy, are not on steroids and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids are allowed.
• • Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.
• Exclusion Criteria:
• • Spinal cord compression and symptomatic brain metastases
• • Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD
• • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, etc
• • Any banned substance in label