Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.

Korábbi kezelés

• Adjuvant osimertinib therapy was discontinued due to the occurrence of severe adverse events.
• 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.

Más betegség

• Past medical history of ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
• History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.

Laborértékek

• Prior with other adjuvant EGFR-TKIs (excluding osimertinib).

Egyéb

• Patients with only local/regional recurrence.
• Spinal cord compression and symptomatic brain metastases.
• Contraindication for pemetrexed and cisplatin/carboplatin according to local approved label.

• Prior complete surgical resection (R0) and adjuvant osimertinib in EGFRm resectable SIB-IIIA NSCLC (AJCC 7th edition).
• Off-treatment recurrence (including completed 3 years adjuvant osimertinib \& discontinued adjuvant osimertinib before 3 years due to non-recurrence reason).
• 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).
• ≥6 months interval between recurrence and completion or discontinuation of adjuvant osimertinib.
• Histologically/cytologically confirmed nonsquamous NSCLC (Investigators confirmed recurrence of primary lesion allowed if biopsy not available)
• No prior systemic anti-cancer therapy after adjuvant therapy, but can receive local therapy (including surgery, radiotherapy, etc. per investigator choice).
• Patients with asymptomatic or stable CNS metastases allowed.
• Male or female, at least 18 years of age. Type of patient and disease characteristics
• EGFR mutation (Exon 19del/Exon 21 L858R)-reconfirmed for study entry (mandatory undergo NGS by plasma, and tissue if applicable).
• Life expectancy >12 weeks at Day 1.