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

Other illness

• 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

Other

• Spinal cord compression and symptomatic brain metastases
• Any banned substance in label

• 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.