Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer
NCT ID: NCT06752408
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
316 participants
INTERVENTIONAL
2024-12-17
2028-01-16
Brief Summary
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Detailed Description
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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Participants can continue to receive treatment as long as they have not withdrawn consent, as long as they choose to continue to receive treatment and are judged by their doctor to continue to receive clinical benefit from receiving the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 .
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aumolertinib
Aumolertinib
Aumolertinib will be administered orally at a dose of 110 mg per time, Q.D.
Osimertinib
Osimertinib
Osimertinib will be administered orally at a dose of 80 mg per time, Q.D.
Interventions
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Aumolertinib
Aumolertinib will be administered orally at a dose of 110 mg per time, Q.D.
Osimertinib
Osimertinib will be administered orally at a dose of 80 mg per time, Q.D.
Eligibility Criteria
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Inclusion Criteria
2. Participants voluntarily signed an informed consent form prior to participation.
3. 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.
4. 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.
5. 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).
6. No prior systemic therapy was allowed, except in the adjuvant or neoadjuvant setting, and no progression was allowed within 6 months.
7. 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
2. History of other primary malignant tumors.
3. Hypersensitivity or allergy to aumolertinib or osimertinib or their excipients.
4. Female subjects who are pregnant, lactating, or planning to become pregnant during the treatment period.
5. 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.
18 Years
75 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Wang mengzhao
Professor
Locations
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Peking Union Medical College Hospital,
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wang Mengzhao, M.D.
Role: primary
Other Identifiers
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K6674
Identifier Type: -
Identifier Source: org_study_id