Osimertinib combined with chemotherapy in patients who had distant recurrence after adjuvant osimertinib for EGFRm resectable SIB-IIIA NSCLC. - REVIVE

Inclusion Criteria

• Inclusion Criteria for pre-screening:
• 1.Prior complete surgical resection (R0) and adjuvant osimertinib in EGFRm resectable SIB-IIIA NSCLC (AJCC 7th edition).
• 2.Off-treatment recurrence (including completed 3 years adjuvant osimertinib & discontinued adjuvant osimertinib before 3 years due to non-recurrence reason).
• 3.Newly diagnosed distant recurrent NSCLC (IVA or IVB) (per Version 9 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology).
• 4.≥6 months interval between recurrence and completion or discontinuation of adjuvant osimertinib.
• 5.Histologically/cytologically confirmed nonsquamous NSCLC (Investigators confirmed recurrence of primary lesion allowed if biopsy not available)
• 6.No prior systemic anti-cancer therapy after adjuvant therapy, but can receive local therapy (including surgery, radiotherapy, etc. per investigator choice).
• 7.Patients with asymptomatic or stable CNS metastases allowed.
• Inclusion Criteria for screening:
• 1.Male or female, at least 18 years of age.
• Type of patient and disease characteristics
• 2.EGFR mutation (Exon 19del/Exon 21 L858R)-reconfirmed for study entry (mandatory undergo NGS by plasma, and tissue if applicable).
• 3.Life expectancy >12 weeks at Day 1.
• Exclusion Criteria:
• 1. Patients with only local/regional recurrence.
• 2.Spinal cord compression and symptomatic brain metastases.
• 3.Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
• 4.Adjuvant osimertinib therapy was discontinued due to the occurrence of severe adverse events.
• 5.Prior with other adjuvant EGFR-TKIs (excluding osimertinib).
• 6.Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.
• 7.History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
• 8.Contraindication for pemetrexed and cisplatin/carboplatin according to local approved label.