Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLC

Sponsor
Sun Yat-sen University
Study ID
NCT05011487
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    80mg/qd oral for 60 days
  • Cisplatin — DRUG
    Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles.
  • Pemetrexed — DRUG
    Pemetrexed (500 mg/m2) to be administered with cisplatin on Day 1 of every 3-week cycle for 2 cycles

Study Details

This is a phase II, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable EGFR-mutant stage III (N2) non-squamous non-small cell lung cancer

Key Dates

Start date
Aug 13, 2021
Status verified
Jan 2024
Primary completion
Sep 1, 2023
Completion
Sep 30, 2028

Study Design

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

Arms

  • Experimental: osimertinib plus chemotherapy
    Osimertinib (80mg/qd) po. for 60 days with two cycles of Pemetrexed (500 mg/m2) to be administered with cisplatin (75mg/m2) on Day 1 of every 3-week cycle for 2 cycles

Primary Outcome Measure

complete lymph node clearance rate [ Time Frame: From date of enrollment to an average of 12 weeks after the first dose ]

Central Contacts

Related Studies