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In this open-label, single-arm, phase 2 study, 40 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive furmonertinib for 9 weeks combined with cisplatin/pemetrexed for 3 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. Radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. Adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Furmonertinib plus cisplatin/pemetrexed | Experimental | furmonertinib 80mg/d for 9 weeks and cisplatin 75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv at 21 day cycles for 3 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furmonertinib+cisplating/pemetrexed | Drug | Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The proportion of patients with complete response or partial response | Approximately 9 weeks following the first dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response rate | The proportion of patients with pathological response in the resected tumor | Approximately 12 weeks following the first dose of study drug |
| Pathological complete response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Lei, MD | Contact | 15094079004 | leijiemd@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital | Recruiting | Xi'an | Shannxi | China |
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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 |
|---|---|
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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The proportion of patients with pathological response rate in the resected tumor
| Approximately 12 weeks following the first dose of study drug |
| R0 resection rate | The proportion of patients with R0 resection | Approximately 12 weeks following the first dose of study drugs |
| Disease free survival | The time from enrolment to disease recurrence or death, which ever comes first | Approximately 3 years following the first dose of study drugs |
| Overall survival | The time from enrolment to death of any reason | Approximately 5 years following the first dose of study drugs |
| Pathological downstaging of lymph node rate | The proportion of patients with pathological downstaging of lymph node rate | Approximately 12 weeks following the first dose of study drugs |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |