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Not Yet RecruitingNCT07279935

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

Biomarker-Directed Treatment in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC: A Prospective, Multi-cohort, Interventional Study (REVIVE)

Status
Not Yet Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
AstraZeneca · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGOsimertinib+cisplatin or carboplatin + pemetrexed EditCohort 1 treated with osimertinib 80 mg once daily (QD) in combination with platinum-based chemotherapy cisplatin \[75 mg/m2\] or carboplatin \[AUC5\]) plus pemetrexed (500 mg/m2) on Day 1 every 3 weeks (Q3W) for 4 cycles, followed by osimertinib QD and pemetrexed Q3W till RECIST 1.1-defined progression or until another discontinuation criterion is met.

Timeline

Start date
2026-05-31
Primary completion
2030-05-18
Completion
2030-05-18
First posted
2025-12-12
Last updated
2026-03-19

Locations

30 sites across 1 country: China

Source: ClinicalTrials.gov record NCT07279935. Inclusion in this directory is not an endorsement.