Aumolertinib with or Without Chemotherapy As 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Sensitizing EGFR Mutations

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study ID
NCT04923906
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Aumolertinib — DRUG
    Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4\~6 cycles, followed by Aumolertinib 100mg QD with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles. Dose may be reduced to allow for the management of investigational drug related toxicity.
  • Placebo Aumolertinib — DRUG
    Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.

Study Details

To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).

Key Dates

Start date
Aug 11, 2021
Status verified
Nov 2024
Primary completion
Jun 18, 2024
Completion
Jan 31, 2026

Study Design

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

Arms

  • Experimental: Aumolertinib and platinum-based chemotherapy
  • Active Comparator: Aumolertinib

Primary Outcome Measure

PFS (Progression Free Survival) assessed by IRC (Independent Review Committee) [ Time Frame: From the time of randomization to disease progression or death, approximately 3 years. ]

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