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| Name | Class |
|---|---|
| Hospital de Base | OTHER |
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The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose nivolumab combined with platinum-based doublet chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose nivolumab combined with platinum-based doublet chemotherapy | Drug | Platinum-based neoadjuvant chemotherapy (carboplatin at AUC 5 or 6 combined with either paclitaxel at 175 mg/m² or pemetrexed at 500 mg/m²), administered with nivolumab at 0.3 mg/kg every 21 days for 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathologic Response | MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery. | 2-3 months |
| Pathologic Complete Response | Pathological complete response (pCR) is defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review of the surgical specimen. | 2-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants. | Up to 3 months after the end of treatment |
| Event-Free-Survival | Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of conversion from minimally invasive surgery to open surgery | The frequency at which a minimally invasive procedure needs to be converted to an open surgical approach mid-operation | 2-3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JOAO A SOLER, MD | Contact | +55 17 981350180 | joao.soler@hbonco.org.br | |
| ALINE FARES, MD | Contact | aline.fares@edu.famerp.br |
| Name | Affiliation | Role |
|---|---|---|
| JOAO A SOLER, MD | FUNDACAO FACULDADE REGIONAL DE MEDICINA DE SAO JOSE DO RIO PRETO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto | Recruiting | São José do Rio Preto | São Paulo | 15090000 | Brazil |
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|
| Up to 60 months |
| R0 resection | R0 resection rate is defined as the proportion of participants who have achieved R0 resection (complete resection with no residual tumor cell in the resection margin) in all participants. | Up to 3 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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