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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
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The goal of this clinical trial is to test in Locally Advanced or Metastatic Non-small Cell Lung Cancer patients with EGFR Mutations. The main question it aims to answer is:
Evaluation of the Efficacy and Safety of Aumolertinib in Combination with Lastet for the Treatment of EGFR-Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer in First-line Therapy.
Participants will be treated with a combination of Aumolertinib and Lastet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination therapy | Experimental | Almonertinib, dosing regimen: 110mg/day orally, once daily in a 28-day cycle, continuously. Lastet, dosing regimen: 50 mg/day orally, every 28 days in a cycle, two weeks of continuous oral administration, two weeks off. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonertinib | Drug | Almonertinib, dosing regimen: 110mg/day orally, once daily in a 28-day cycle, continuously. Lastet, dosing regimen: 50 mg/day orally, every 28 days in a cycle, two weeks of continuous oral administration, two weeks off. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | PFS is defined as the period from the start of treatment until the disease progresses or the patient dies from any cause, whichever came first, assessed up to 24 months | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | Disease Control Rate (DCR) is to describe the proportion of patients who have achieved a response to treatment that includes not only complete and partial responses but also stable disease. | 24 months |
| Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianing Chen | Contact | 18916469896 | johnny042018@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunxia Su | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40306921 | Derived | Chen J, Wang L, Liu L, Zhao J, Wu Y, Yu X, Su C. Aumolertinib in combination with Lastet in the first-line treatment of EGFR-mutated, locally advanced or metastatic non-small cell lung cancer (EVOLUTION): protocol for a single-arm, phase II clinical trial. BMJ Open. 2025 Apr 29;15(4):e097576. doi: 10.1136/bmjopen-2024-097576. |
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In clinical trials, it is essential to strictly protect the privacy of patients' personal information. Data sharing may inappropriately increase the risk of privacy breaches, especially when data anonymization is not handled properly. Additionally, researchers or sponsors, based on their considerations of data ownership and intellectual property rights, have the authority to decide whether and how to share the data.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000718108 | aumolertinib |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
The Duration of Response (DoR) is a clinical measure to determine the length of time that a tumor continues to respond to treatment without the cancer worsening.
| 24 months |
| Objective Response Rate | The Objective Response Rate (ORR) is a key metric used in oncology to assess the proportion of patients in a study or treatment group who achieve an objective response (CR or PR). | 24 months |
| Overall Survival | OS is measured from the date of the initiation of treatment to the date of death from any cause, whichever came first, assessed up to 24 months | up to 24 months |
| The First Affiliated Hospital of Xiamen University | Xiamen | 361003 | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |