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

Sponsor
AstraZeneca
Study ID
NCT07279935
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib+cisplatin or carboplatin + pemetrexed Edit — DRUG
    Cohort 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.

Study Details

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.

Key Dates

Start date
May 26, 2026
Status verified
May 2026
Primary completion
May 18, 2030
Completion
May 18, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort1
    Treatment allocation according to molecular profile at recurrence. Cohort 1 consists of patients with Ex19del or L858R mutation.

Primary Outcome Measure

To assess the efficacy of osimertinib + chemotherapy by evaluation of PFS in patients who had distant recurrence after adjuvant osimertinib. [ Time Frame: Approximately 52 months ]

Central Contacts

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