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

This study is designed as a multi-cohort trial based on various patient biomarkers study with the potential to include new study treatment in the future. EGFR-sensitive mutation-positive patients with distant recurrence after adjuvant osimertinib treatment for EGFRm resectable SIB-IIIA NSCLC and scheduled to receive osimertinib plus chemotherapy will be enrolled in cohort 1. In this cohort, approximately 100 patients will be recruited from 25 sites in China. The enrolment period is planned to be approximately 16 months.

Trial Details

NCT ID
NCT07279935
Phase
PHASE4
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Osimertinib+cisplatin or carboplatin + pemetrexed Edit
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723
  • Chengdu, China|30.66667,104.06667
  • Chengdu, China|30.66667,104.06667

Key Eligibility Criteria

  • 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-recurrenc…
  • Newly diagnosed distant recurrent NSCLC (IVA or IVB) (per Version 9 of the International Association for the Study of Lung Cancer \[IASLC\] Staging…
  • ≥6 months interval between recurrence and completion or discontinuation of adjuvant osimertinib.

For full eligibility, visit ClinicalTrials.gov.

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