Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer

Official title

Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer: a Randomized, Open-label, Non-inferiority Real World Study

Overview

This is a multicenter, randomized, open-label, non-inferiority real world study. The study is designed to evaluate the efficacy and safety of Aumolertinib versus Osimertinib in the first-line treatment of patients with EGFR mutated locally advanced or metastatic non-small-cell lung cancer.

Detailed description

Aumolertinib and Osimertinib are both third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) that were approved for non-small cell lung cancer (NSCLC) patients with EGFR mutation.

This study will compare the efficacy of two different EGFR-TKIs, Aumolertinib and Osimertinib, when administered as monotherapy.

This is a multicenter, randomized, open-label study with 2 different groups that are listed below.

In a randomized study, the treatment that participants receive is randomly assigned, with the assignment determined by a computer algorithm. In an "open-label" study, both the participants and the investigators are aware of the treatment allocation for each participant.

Participants will be randomly assigned to one of the following two treatment groups:

Group 1: Treatment with Aumolertinib alone, taken orally as two pills once a day. Around 158 participants will be randomly assigned to this group.

Group 2: Treatment with Osimertinib alone, taken orally as one pill once a day. Around 158 participants will be randomly assigned to this group.

Participants can continue to receive treatment as long as they have not withdrawn consent, as long as they choose to continue to receive treatment and are judged by their doctor to continue to receive clinical benefit from receiving the treatment, and as long as no other exclusion and/or discontinuation criteria are met .

Interventions

• Drug Aumolertinib
  Aumolertinib will be administered orally at a dose of 110 mg per time, Q.D.
• Drug Osimertinib
  Osimertinib will be administered orally at a dose of 80 mg per time, Q.D.

Primary outcome measures

• Progression Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Time frame: Up to 3 years]

Secondary outcome measures (6)

• Overall Survival (OS) [Time frame: Up to 5 years]
• Objective Response Rate (ORR) as Assessed by Investigator Per RECIST v1.1 [Time frame: Up to 3 years]
• Disease Control Rate (DCR) as Assessed by Investigator Per RECIST v1.1 [Time frame: Up to 3 years]
• Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1 [Time frame: Up to 3 years]
• Depth of Response (DepOR) as Assessed by Investigator Per RECIST v1.1 [Time frame: Up to 3 years]
• Treatment-emergent adverse events (TEAEs) [Time frame: From first dose until 28 days after the last dose, up to 36 month]

Eligibility criteria

Inclusion criteria

• At least 18 years old.
• Participants voluntarily signed an informed consent form prior to participation.
• The Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1, no deterioration for at least 1 week before treatment, and the expected survival period is no less than 12 weeks.
• Histologically or cytologically confirmed stage IIIB-IV NSCLC (according to the AJCC eighth edition lung cancer staging criteria), metastatic or recurrent lung cancer that is not amenable to curative intent therapy.
• Positive EGFR mutation confirmed by tissue or cytology(including peripheral blood, pleural effusion, ascites, cerebrospinal fluid) with at least one sensitizing mutation (L858R or 19Del).
• No prior systemic therapy was allowed, except in the adjuvant or neoadjuvant setting, and no progression was allowed within 6 months.
• According to RECIST1.1, the patient must have at least one target lung lesion. The requirements for target lesions are: measurable lesions that have not undergone local treatment such as radiation, with the longest diameter at baseline ≥10 mm (if it is a lymph node, the maximum short diameter must be ≥15 mm).

Exclusion criteria

• Diagnosis of meningeal metastasis by clinical symptoms or imaging or cerebrospinal fl-uid, or brain parenchymal metastasis combined with meningeal metastasis.
• History of other primary malignant tumors.
• Hypersensitivity or allergy to aumolertinib or osimertinib or their excipients.
• Female subjects who are pregnant, lactating, or planning to become pregnant during the treatment period.
• The investigator assesses whether there are any patients with conditions that may compromise patient safety or interfere with the evaluation of the study, such as poorly controlled hypertension, active bleeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Peking Union Medical College Hospital, — Beijing

Identifiers

NCT: NCT06752408 · K6674

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗