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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| China-Japan Friendship Hospital | OTHER |
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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.
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Participants can continue to receive treatment as long as they have not withdrawn consent, as long as they choose to continue to receive treatment and are judged by their doctor to continue to receive clinical benefit from receiving the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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aumolertinib | Experimental |
| |
| Osimertinib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aumolertinib | Drug | Aumolertinib will be administered orally at a dose of 110 mg per time, Q.D. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from date of randomization until death from any cause. | Up to 5 years |
| Objective Response Rate (ORR) as Assessed by Investigator Per RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao Jing, M.D. | Contact | 010-69155039 | pumchzj@sina.com | |
| Wang Mengzhao, M.D. | Contact | 010-69155039 | mengzhaowang@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, | Beijing | Beijing Municipality | 100730 | China |
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| Osimertinib | Drug | Osimertinib will be administered orally at a dose of 80 mg per time, Q.D. |
|
ORR is defined as proportion of participants who achieve a complete response or partial response at any time before progressive disease or initiating a subsequent anticancer therapy.
| Up to 3 years |
| Disease Control Rate (DCR) as Assessed by Investigator Per RECIST v1.1 | DCR is defined as the proportion of participants who have a best overall response of complete response or partial response or stable disease. | Up to 3 years |
| Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1 | DOR is defined as date of first response (complete response or partial response) until date of disease progression or death due to any cause, whichever occurs first. | Up to 3 years |
| Depth of Response (DepOR) as Assessed by Investigator Per RECIST v1.1 | DepOR is defined as the relative change in target lesion tumor size (calculated as the sum of the longest diameters of the target lesions, in the absence of new lesions or progression of nontarget lesions) as compared to baseline. | Up to 3 years |
| Treatment-emergent adverse events (TEAEs) | This outcome measures the type, incidence, grade and severity of treatment-emergent adverse events (TEAEs) that occur during treatment (as determined by the NCI-CTCAE v 5.0). | From first dose until 28 days after the last dose, up to 36 month |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000718108 | aumolertinib |
| C000596361 | osimertinib |
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