Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
22 participants
INTERVENTIONAL
2023-05-12
2028-06-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: Neodjuvant treatment + Adjuvant maintenance treatment
Neodjuvant treatment:
Nivolumab: 360 mg intravenous Q3W Paclitaxel: 200mg/m2 infusion over 3 hours Carboplatin: AUC6 at the end of the Paclitaxel infusion
Neoadjuvant treatment will start within 1-3 days from enrollment. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery.
Surgery: Surgery must be done within the 3rd-4th week (+7 days) from day 21 cycle 3 of neoadjuvant treatment (day 42-49 after day 1 of cycle 3)
Depending on surgery results the patient will receive:
* Patients with degree of resection 'R0': Adjuvant treatment for 6 months with Nivolumab 480mg QW4
* Patients with degree of resection 'R1' or 'R2': standard treatment according to local guidelines
Carboplatin
Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, sodium chloride and glucose 5% solution solution or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin.
Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of ech center.
Paclitaxel
Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hydroxy-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.
Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.
Guidelines on Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
Nivolumab
Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains. Route of administration: Intravenous infusion. Product Description: Nivolumab (BMS-936558-01) Injection drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated in 10 mg/ml.
Storage Conditions: It must be stored at 2 to 8 degrees Cº and protected from light and freezing.
Guidelines: The administration of nivolumab infusion must be completed within 24 hours of preparation.The dose of Nivolumab for the adjuvant treatment is 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks (+/-3 days) for 3 cycles.
For the maintenance adjuvant treatment the dose is nivolumab 480 mg Q4W (+/-3 days) over 30 minutes for 6 months (6 cycles).
Subjects should be carefully monitored during nivolumab administration to follow infusion reactions. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment.
Interventions
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Carboplatin
Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, sodium chloride and glucose 5% solution solution or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin.
Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of ech center.
Paclitaxel
Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hydroxy-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.
Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.
Guidelines on Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
Nivolumab
Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains. Route of administration: Intravenous infusion. Product Description: Nivolumab (BMS-936558-01) Injection drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated in 10 mg/ml.
Storage Conditions: It must be stored at 2 to 8 degrees Cº and protected from light and freezing.
Guidelines: The administration of nivolumab infusion must be completed within 24 hours of preparation.The dose of Nivolumab for the adjuvant treatment is 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks (+/-3 days) for 3 cycles.
For the maintenance adjuvant treatment the dose is nivolumab 480 mg Q4W (+/-3 days) over 30 minutes for 6 months (6 cycles).
Subjects should be carefully monitored during nivolumab administration to follow infusion reactions. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\. PET/CT including IV contrast (CT of diagnostic quality) will be performed at baseline (28 days +10 before enrollment) to rule out the presence of distant disease. Also, a brain CT-SCAN or brain MRI will be done at baseline
* 3\. Positive mediastinal lymph nodes by PET-CT must be confirmed histologically. Mediastinal involvement may be considered without the need for histological confirmation when there is a mass of lymph nodes in which the margins cannot be distinguished
* 4\. Measurable or evaluable disease (according to RECIST 1.1 criteria)
* 5\. ECOG (Performance status) 0-2
* 6\. Patients with a life expectancy of at least more than 12 weeks
* 7\. Patients aged \> 18 years and ≤ 75 years
* 8 Screening laboratory values must meet the study criteria and should be obtained within 14 days prior to enrollment
* 9\. Correct lung function without bronchodilators, defined by forced expiratory volume in 1 second (FEV1) \>40% of the predicted normal volume, and a pulmonary diffusing capacity for carbon monoxide (DLCO) \>40% of the predicted normal value
* 10\. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention
* 11\. Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before enrollment.
* 12\. All sexually active men and women of childbearing potential must use an effective contraceptive method during the study treatment and for a period of at least 12 months following the last administration of trial drugs
* 13\. Patient capable of proper therapeutic compliance and accessible for correct follow-up.
Exclusion Criteria
* 2\. Pleural or pericardial effusion: Both will be considered indicative of metastatic disease unless proven otherwise. Those that, even being cytologically negative for malignancy, are exudates, will also be excluded. Patients with pleural effusion not visible on chest X-ray or too small to perform diagnostic puncture safely may be included.
* 3\. Patients with a weight loss \>10% in the 3 months prior to the study entry
* 4\. All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene or ROS1 mutations.
* 5\. Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.
* 6\. Patients with symptomatic neuropathy \> grade 1 according to the CTCAE v5.0 and that were not related to the tumor
* 7\. Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* 8\. Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.
* 9\. Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anticancer therapy
* 10\. Patients with uncontrolled comorbidities that may affect the clinical trial compliance
* 11\. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required during the study period.
* 12\. Any medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information sheet.
* 13\. Patients in any psychological, familiar, sociological or geographical situation that may hinder compliance with the study protocol and/or the follow up
* 14\. Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* 15\. Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
* 16\. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
* 17\. Patients with know hypersensitivity to drugs with a structure similar to the study drug and/or history of allergy to study drug components excipients
* 18\. Women who are pregnant or in the period of breastfeeding
* 19\. Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study
18 Years
75 Years
ALL
No
Sponsors
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Fundación GECP
OTHER
Responsible Party
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Principal Investigators
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Mariano Provencio, MD
Role: STUDY_CHAIR
Fundación GECP President
Locations
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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
Hospital Josep Trueta
Girona, , Spain
Hospital Universitario de Jaén
Jaén, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital 12 De Octubre
Madrid, , Spain
Hospital Universitario la Paz
Madrid, , Spain
Fundació Althaïa
Manresa, , Spain
Hospital Universitario Regional de Málaga
Málaga, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Hospital Universitario Salamanca
Salamanca, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Consorci Sanitari de Terrassa
Terrassa, , Spain
Hospital Clínico de Valencia
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Complexo Hospitalario Universitario De Vigo
Vigo, , Spain
Countries
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Central Contacts
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Facility Contacts
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Laura Puntí, MD
Role: primary
Mª Ángeles Moreno, MD
Role: primary
Mariano Provencio, MD
Role: primary
María Guirado, MD
Role: primary
Andrés Aguilar, MD
Role: primary
Alex Martínez, MD
Role: primary
Noemí Reguart
Role: primary
Julia Giner, MD
Role: primary
Eider Azkona Uribelarrea, MD
Role: primary
Rubén Alonso Calderón, MD
Role: primary
Elia Sais Girona, MD
Role: primary
Ana Laura Ortega Granados, MD
Role: primary
Begoña Campos, MD
Role: primary
Carlos Aguado, MD
Role: primary
Manuel Dómine, MD
Role: primary
Luis Paz-Ares, MD
Role: primary
Javier De Castro, MD
Role: primary
Silvia Catot, MD
Role: primary
José Miguel Jurado, MD
Role: primary
Raquel Marsé, MD
Role: primary
Edel del Barco, MD
Role: primary
Miriram Alonso, MD
Role: primary
Marc Campayo, MD
Role: primary
Amelia Insa, MD
Role: primary
Paula Espinosa, MD
Role: primary
Inmaculada Maestu, MD
Role: primary
Francisco Aparisi, MD
Role: primary
Rafael López, MD
Role: primary
Martín Lázaro, MD
Role: primary
Related Links
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Web page of the sponsor where users can find more information about Fundación GECP studies
Other Identifiers
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2022-003717-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GECP 22/02_DUMAS
Identifier Type: -
Identifier Source: org_study_id
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