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

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 1\. Previously untreated patients with histologically- or cytologically- documented NSCLC diagnosed with Pancoast tumor according to 8th edition of the TNM (stages IIB, IIIA and T3N2 (IIIB) patients)

• 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.

Locations
Other Locations
Spain
Hospital General Universitario de Elche
RECRUITING
Alicante
Hospital Clínic De Barcelona
RECRUITING
Barcelona
Hospital Parc Taulí
RECRUITING
Barcelona
Hospital Universitari Quiron Dexeus
RECRUITING
Barcelona
Hospital Universitari Vall d' Hebron
RECRUITING
Barcelona
Hospital Universitario de Cruces
RECRUITING
Bilbao
Hospital San Pedro De Alcántara
RECRUITING
Cáceres
Hospital Josep Trueta
RECRUITING
Girona
Hospital Universitario de Jaén
RECRUITING
Jaén
Hospital Universitario Jerez De La Frontera
RECRUITING
Jerez De La Frontera
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Hospital 12 De Octubre
RECRUITING
Madrid
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario la Paz
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
RECRUITING
Majadahonda
Hospital Universitario Regional de Málaga
RECRUITING
Málaga
Fundació Althaïa
RECRUITING
Manresa
Hospital De Mataro
RECRUITING
Mataró
Hospital Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitario Salamanca
RECRUITING
Salamanca
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Consorci Sanitari de Terrassa
RECRUITING
Terrassa
Hospital Clínico de Valencia
RECRUITING
Valencia
Hospital General Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario Dr. Peset
RECRUITING
Valencia
Hospital Universitario La Fe
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Complexo Hospitalario Universitario De Vigo
RECRUITING
Vigo
Contact Information
Primary
Eva Pereira
gecp@gecp.org
+34934302006
Time Frame
Start Date: 2023-05-12
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 22
Treatments
Experimental: 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
Sponsors
Leads: Fundación GECP

This content was sourced from clinicaltrials.gov

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