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This is a Phase 2 study to evaluate the efficacy and the safety/ tolerability of Almonertinib in NSCLC patients with uncommon EGFR Mutation or EGFR exon 20 insertion mutations. Patients with EGFR exon 20 insertion mutations have to had at least one prior systemic treatment for locally advanced or metastatic NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Previously treated NSCLC patients with EGFR exon 20 insertion mutantion |
|
| Cohort 2 | Experimental | NSCLC Patients with uncommon EGFR Mutation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almonertinib | Drug | single agent, 110mg p.o once daily until disease progressed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of Almonertinib to the end of study. | To evaluate objective response rate 6-8 weeks after the initiation of Almonertinib |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | The PFS time is defined as time from enrollment to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of : "death", "last tumor assessment", "last follow up date" or "last date in drug log" | 30 months |
| Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient has had previous treatment with Pyrotinib, Poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dingzhi Huang | Contact | 86-22-23340123 | 3200 | dingzhih72@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dingzhi Huang | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | China |
Identified individul participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion
Data access requests will be reviewed by an external indepentent Review Panel. Requestors will be required to sign a Data Access Agreement.
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Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease). |
| 30 months |
| Overall Survival | OS was defined as time from date of enrollment to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive. | 30 months |
| Duration of Response | Number of days from the date that measurement criteria are first met for CR or PR (whichever status is recorded first) until the first subsequent date that progressive disease or death is documented. | 30 months |
| Safety and Tolerability | Number of Participants with treatment related Adverse Events as Assessed by CTCAE v5.0 | 30 months |
| 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 |
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