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

Inclusion Criteria:

• Age ≥18 years

• Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixedhistology is allowed.

• Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on theAmerican Joint Committee on Cancer Edition 8) not amenable to curative surgery ordefinitive chemoradiation.

• EGFR sensitive mutation-positive (Ex19del and/or 21 L858R)

• WHO performance status of 0 to 2 at screening with no clinically significantdeterioration in the previous 2 weeks.

• Patients who receive Osimertinib plus chemotherapy as first-line treatment based onphysician's medical assessment are eligible (For patients who received priorchemotherapy alone/Osimertinib monotherapy/Osimertinib plus chemotherapy asfirst-line therapy ahead of enrolment, they are diseases progression-free at thetime of enrolment and the duration of prior therapy ≤3 months).

• Patients with asymptomatic CNS metastases or patients who have completed definitivetherapy, are not on steroids and have a stable neurological status for at least 2weeks after completion of the definitive therapy and steroids are allowed.

• Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy,immunotherapy, biologic therapy, investigational agents), or definitiveradiation/chemoradiation with or without regimens including immunotherapy, biologictherapies, investigational agents are permitted as long as treatment was completedat 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 requiredsteroid treatment, or any evidence of clinically active ILD

• Any evidence of severe or uncontrolled systemic diseases, including uncontrolledhypertension and active bleeding diatheses, etc

• Any banned substance in label