Almonertinib Vs. Erlotinib/Chemotherapy for Neo-adjuVant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC

Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Study ID
NCT04455594
Phase
PHASE2
Status
Unknown

Conditions

  • Non-Small Cell Lung Cancer Stage IIIA

Eligibility Criteria

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

Interventions

  • Almonertinib — DRUG
    Oral, 110mg QD
  • Erlotinib — DRUG
    Oral, 150mg QD
  • Cisplatin — DRUG
    Cisplatin(75mg/m2) be administered with pemetrexed (500mg/m2) on Day 1 of every 3-week cycle for 3 cycles
  • Carboplatin — DRUG
    Carboplatin (AUC=5) to be administered with pemetrexed (500mg/m2) on Day 1 of every 3-week cycle for 3 cycles
  • Pemetrexed — DRUG
    Pemetrexed (500mg/m2) to be administered with Cisplatin(75mg/m2) or Carboplatin (AUC=5) on Day 1 of every 3-week cycle for 3 cycles

Study Details

This is a multicenter, randomized, controlled, phase II study assessing the efficacy and safety of Almonertinib compared Erlotinib or platinum doublet chemotherapy (carboplatin or cisplatin + pemetrexed) as neoadjuvant therapy to EGFRm+ IIIA-N2 NSCLC patients.

Key Dates

First listed
Jul 2, 2020
Start date
Oct 31, 2020
Status verified
Jun 2020
Primary completion
Jan 31, 2023
Completion
Oct 31, 2025

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Almonertinib
    Almonertinib 110mg QD
  • Active Comparator: Investigator-choice therapy (Erlotinib or Chemotherapy)
    Erlotinib 150mg QD or Cisplatin(75mg/m2) or Carboplatin (AUC=5) to be administered with pemetrexed (500mg/m2) on Day 1 of every 3-week cycle for 3 cycles

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: From date of randomization to an average of 6 weeks after the first dose ]

Central Contacts

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