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

NCT06752408 | Not Yet Recruiting Phase 2

• 1 other identifier: K6674
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; EGFR mutation; Aumolertinib; Osimertinib

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.

  Up to 3 years

Secondary Outcomes (6)

• Overall Survival (OS)

  Up to 5 years

• Objective Response Rate (ORR) as Assessed by Investigator Per RECIST v1.1

  Up to 3 years

• Disease Control Rate (DCR) as Assessed by Investigator Per RECIST v1.1

  Up to 3 years

• Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1

  Up to 3 years

• Depth of Response (DepOR) as Assessed by Investigator Per RECIST v1.1

  Up to 3 years

Study Arms (2)

Aumolertinib

EXPERIMENTAL

Drug: Aumolertinib

Osimertinib

ACTIVE COMPARATOR

Drug: Osimertinib

Interventions

Aumolertinib DRUG

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

Aumolertinib

Osimertinib DRUG

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

Osimertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Peking University People's Hospital: collaborator
• China-Japan Friendship Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital,

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aumolertinib; osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zhao Jing, M.D.

CONTACT

010-69155039; pumchzj@sina.com

Wang Mengzhao, M.D.

CONTACT

010-69155039; mengzhaowang@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 30, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): January 16, 2027
• Study Completion (Estimated): January 16, 2028
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)