Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03081689|
Recruitment Status : Active, not recruiting
First Posted : March 16, 2017
Last Update Posted : November 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Nivolumab 360 mg Drug: Paclitaxel 200mg/m2 Drug: Carboplatin AUC 6||Phase 2|
Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months.
Three cycles of neoadjuvant chemotherapy in combination with nivolumab will be administered.
After completion of neoadjuvant therapy (3 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression. Patients with in-stable disease or partial response may be considered for surgery.
The report imaging response vs pathological response rate will be evaluated.
Patients eligible for the trial are those with a histological diagnosis or cytologically proven operable and resectable non-small-cell lung cancer. The total number of patients to be included will be 46 from 23 participating sites in Spain.
Accrual period of 1.5 years or until the inclusion of the last patient necessary to achieve the sample set in the protocol of 46 patients. After that all patients will be treated for 1 year with adjuvant immunotherapy and they will be followed during 3 years after adjuvant treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neo - Adjuvant Chemo / Immunotherapy for the Treatment of Resectable Stage IIIA Non Small Cell Lung Cancer (NSCLC): A Phase II Multicenter Exploratory Study|
|Actual Study Start Date :||April 15, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Arm 1
Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Drug: Nivolumab 360 mg
Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
Other Name: OPDIVO
Drug: Paclitaxel 200mg/m2
Paclitaxel 200mg/m2 IV Q3W
Other Name: Paclitaxel
Drug: Carboplatin AUC 6
Carboplatin AUC 6 IV Q3W
Other Name: Carboplatin
- Progression free survival [ Time Frame: at 24 months from the first dose of neadjuvant treatment ]The progression free survival is the time until the patients disease progresses
- Overall survival [ Time Frame: at 3 years from the first dose of neoadjuvant treatment ]Time when the patient is still alive
- Toxicity profile [ Time Frame: from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment ]Toxicities caused by the drug during the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081689
|Study Chair:||Mariano Provencio, MD||spanish Lun Cancer Group|