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Phase II Clinical Trial of Neo-adjuvant Chemo/Immunotherapy Followed by Adjuvant Treatment Depending on the Resection Status for the Treatment of NSCLC Patients Diagnosed With Pancoast Tumor. A Multicenter Exploratory Study
The goal of this clinical trial is to test the efficacy of induction treatment of immunotherapy and chemotherapy depending on the resection status for the treatment of non small cell lung cancer patients diagnosed with pancoast tumor. The main objectives it aims to answer are: * Complete resection rate after induction treatment with chemotherapy plus nivolumab * Overall Survival and Progression Free Survival at 24 months The sample size is 40 patients.
This is an open-label, phase II, single-arm, multi-centre clinical trial. The total sample size is 40 patients. The population to be included are previously untreated patients with histologically- or cytologically- documented NSCLC diagnosed with Pancoast tumor. Patients will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC6 for 3 cycles every 21 days (+/- 3 days) as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Nivolumab 480 mg Q4W (+/- 3 days) if applicable and depending on surgery results. Patients that will not receive adjuvant treatment will start follow up phase after end of treatment visit. Follow up for all patients must be done for 2 years. The primary objective is to evaluate the complete resection (R0) rate after induction treatment defined as the absence of residual tumor in patients treated with neoadjuvant chemo-immunotherapy.Secondary objectives and endpoint are Overall survival rate at 24 months and disease-free survival rate at 24 months. Patient accrual is expected to be completed within 2 years excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 5 years. The study will end once survival follow-up has concluded.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Hospital De Mataro
Mataró, Barcelona, Spain
Hospital Universitario Jerez De La Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital General Universitario de Elche
Alicante, Spain
Hospital Universitari Quiron Dexeus
Barcelona, Spain
Hospital Universitari Vall d' Hebron
Barcelona, Spain
Hospital Clínic De Barcelona
Barcelona, Spain
Hospital Parc Taulí
Barcelona, Spain
Hospital Universitario de Cruces
Bilbao, Spain
Hospital San Pedro De Alcántara
Cáceres, Spain
Start Date
May 12, 2023
Primary Completion Date
March 1, 2028
Completion Date
June 1, 2028
Last Updated
April 10, 2025
22
ESTIMATED participants
Carboplatin
DRUG
Paclitaxel
DRUG
Nivolumab
DRUG
Lead Sponsor
Fundación GECP
NCT07486219
NCT06305754
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05098132