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Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases (NIVIPI-Brain)

Primary Purpose

Non Small Cell Lung Cancer, Brain Metastases, Adult, Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ipilimumab
Nivolumab
Carboplatin
Cisplatin
Paclitaxel
Pemetrexed
Sponsored by
Fundación GECP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Lung Diseases, Chemotherapy, Immunotherapy, Induction chemotherapy, Maintenance treatment, Nivolumab, Ipilimumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COHORT A Patients with histologically or cytologically confirmed stage IV NSCLC who did not receive any prior systemic therapy for advanced disease and have synchronous untreated brain metastases which does not cause neurologic symptoms and does not require systemic corticosteroid treatment within 10 days before initiating study treatment (controlled seizures with antiepileptic drugs should be allowed).
  • COHORT B Patients with histologically or cytologically confirmed stage IV NSCLC who did not receive any prior systemic therapy for advanced disease and have synchronous brain metastasis causing neurologic signs and symptoms controlled with medium-low doses of corticosteroids (≤ 25mg/d of prednisone or ≤ 4mg/d of dexamethasone) but have good performance status (ECOG PS0-1). At least one untreated brain lesion in patients who already received focal radiotherapy (stereotactic focal radiotherapy) of prior brain lesions are eligible if novel brain lesions appear which are measurable and not suitable for focal radiotherapy.3. Patients with early or locally advanced NSCLC who have recurred after 6 months of completing adjuvant or neoadjuvant chemotherapy and have brain metastases are also eligible
  • ECOG performance status 0-1
  • Patients aged ≥ 18 years
  • Systemic measurable disease by computed tomography (CT) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria and brain measurable disease by magnetic resonance imaging (MRI) per RANO-BM criteria.
  • Availability of a formalin-fixed paraffin-embedded block containing tumor tissue or 10 unstained slides. Archival tumor tissue can be sent if it was obtained less than 12 months ago.
  • Correct hematological, hepatic and renal function. i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 ×109/L iii. Hemoglobin ≥ 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 45 mL/min (if using the Cockcroft-Gault formula below): a. Female CrCl = (140 - age in years) x weight in kg x 0.85/ 72 x serum creatinine in mg/dL b. Male CrCl = (140 - age in years) x weight in kg x 1.00/ 72 x serum creatinine in mg/dL v. AST/ALT ≤ 3 x ULN. Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 x ULN) vii. PT/APTT ≤ 1.5 × upper limit of normal (ULN). This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose
  • Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements
  • Patients must be accessible for treatment and follow-up
  • 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 3 days before randomization.
  • All sexually active men and women of childbearing potential must use a highly effective contraceptive method (<1% failure rate) during the study treatment and for a period of at least 5 months for females and 7 months for males following the last administration of trial drugs.

Exclusion Criteria:

  • Patients with a history of other malignant diseases within the past 3 years, with the exception of the following:

    • properly treated non-melanotic skin cancer
    • cancer in situ treated with curative intent
    • nonmuscular propria invasive carcinoma of the bladder
    • or other malignancies treated with curative intent and without signs of disease for a period of > 3 years after the end of the treatment and which, in the opinion of the physician in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease.
  • Patients harboring epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) and ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy
  • Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma
  • Patients that received live attenuated vaccines within 30 days prior to randomization
  • Leptomeningeal carcinomatosis or metastases in the brain stem, mid-brain, pons, medulla or causing obstructive hydrocephalus
  • Single exclusive brain metastasis amenable to surgical treatment or radiosurgery
  • Prior surgical resection of brain or spinal lesions in the prior 28 days
  • Patients who have received prior neoadjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy
  • History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments
  • Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to be enrolled
  • Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of radiation pneumonitis put of the radiation field on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Significant comorbidities that preclude the administration of chemotherapy according to the investigator's criteria
  • Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative)
  • Previous treatment with immune checkpoint inhibitors
  • Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction in the previous year or ventricular cardiac arrhythmias that require medication, history of atrioventricular conduction of second or third degree)
  • Pregnant or breastfeeding women
  • History of allergy or hypersensitivity to any of the study drug components
  • Patients with a condition other than brain metastases requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

Sites / Locations

  • ICO Badalona, Hospital Germans Trias i PujolRecruiting
  • ICO HospitaletRecruiting
  • Hospital Provincial de CastellónRecruiting
  • Hospital Universitario Insular de Gran canariaRecruiting
  • Hospitalario Universitario A CoruñaRecruiting
  • Hospital Universitario Puerta de HierroRecruiting
  • Hospital Universitari Vall d' HebronRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario de JaénRecruiting
  • Hospital Universitario de LeónRecruiting
  • Hospital Universitario Lucus AugustiRecruiting
  • Hospital Universitario Fundación Jiménez DíazRecruiting
  • Hospital 12 De OctubreRecruiting
  • Hospital Universitario Regional de MálagaRecruiting
  • Hospital Universitari Son LlatzerRecruiting
  • Hospital General Universitario de ValenciaRecruiting
  • Hospital Universitario La FeRecruiting
  • Hospital Clínico Universitario de ValladolidRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction treatment + Maintenance

Arm Description

Induction: 2 cycles of platinum-based chemotherapy plus (Nivolumab + Ipilimumab): - Non-squamous NSCLC patients: Pemetrexed: 500 mg/m2 IV, Q3W Carboplatin: AUC 5 o 6 or Cisplatin: 75 mg/m2 IV, Q3W Nivolumab: 360 mg IV Q3W Ipilimumab: 1mg/kg IV Q6W 2 cycles will be administered at 21-day intervals (Q3W) for Pemetrexed, Carboplatin/Cisplatin and Nivolumab. Ipilimumab will be administered at 42 days interval (Q6W). - Squamous NSCLC patients: Paclitaxel: 200 mg/m2 IV, Q3W Carboplatin: AUC 5 o 6, Q3W Nivolumab: 360 mg IV, Q3W Ipilimumab: 1mg/kg IV, Q6W Maintenance: following two cycles of chemo-immunotherapy the patients will receive: Nivolumab: 360 mg IV, Q3W Ipilimumab: 1mg/kg IV, Q6W Immunotherapy will be administered until disease progression, unacceptable toxicity, loss of clinical benefit or up to a maximum of 2 years of treatment.

Outcomes

Primary Outcome Measures

Rate of intracranial clinical benefit
Defined as the percentage of patients who had lack of radiological or clinical progression for at least 6 months according to RANO-BM assessment criteria

Secondary Outcome Measures

To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS)
PFS defined as systemic PFS (excluding CNS) as per RECIST version 1.1 and PFS in the CNS as per RANO-BM criteria
To evaluate the Overall Response Rate (ORR) of the treatment
Intracranial ORR, defined as a complete response or partial response as determined by the investigator according to RANO for brain disease. Systemic ORR, defined as a complete response or partial response as determined by the investigator according to RECIST v1.1. criteria for systemic disease.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.

Full Information

First Posted
August 12, 2021
Last Updated
June 22, 2023
Sponsor
Fundación GECP
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1. Study Identification

Unique Protocol Identification Number
NCT05012254
Brief Title
Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases
Acronym
NIVIPI-Brain
Official Title
Nivolumab Plus Ipilimumab Plus Two Cycles of Platinum-based Chemotherapy as First Line Treatment for Stage IV/Recurrent Non-small Cell Lung Cancer (NSCLC) Patients With Synchronous Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
March 15, 2026 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación GECP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open-label, non-randomised, phase II, multicenter clinical trial. 71 stage IV or recurrent, non-small cell lung cancer patients with synchronous brain metastases will be enrolled in this trial to evaluate the efficacy of Nivolumab plus Ipilimumab plus two cycles of platinum-based chemotherapy as first line treatment.
Detailed Description
This is an open-label, non-randomised, phase II, multicenter clinical trial. The total sample size is 71 patients. The population to be included are stage IV or recurrent, non-small cell lung cancer patients with synchronous brain metastases. Patients randomised will receive induction treatment with two cycles of platinum-based chemotherapy plus Nivolumab and Ipilimumab. At the end of induction treatment the patient with start maintenance with Nivolumab and Ipilimumab until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment The primary objective of this trial is to determine the rate of intracranial clinical benefit, defined as the percentage of patients who had lack of radiological or clinical progression for at least 6 months according to RANO-BM assessment criteria. Patient accrual is expected to be completed within 1.5 years, treatment is planned to extend for 1 year and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Brain Metastases, Adult, Lung Cancer
Keywords
Lung Diseases, Chemotherapy, Immunotherapy, Induction chemotherapy, Maintenance treatment, Nivolumab, Ipilimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction treatment + Maintenance
Arm Type
Experimental
Arm Description
Induction: 2 cycles of platinum-based chemotherapy plus (Nivolumab + Ipilimumab): - Non-squamous NSCLC patients: Pemetrexed: 500 mg/m2 IV, Q3W Carboplatin: AUC 5 o 6 or Cisplatin: 75 mg/m2 IV, Q3W Nivolumab: 360 mg IV Q3W Ipilimumab: 1mg/kg IV Q6W 2 cycles will be administered at 21-day intervals (Q3W) for Pemetrexed, Carboplatin/Cisplatin and Nivolumab. Ipilimumab will be administered at 42 days interval (Q6W). - Squamous NSCLC patients: Paclitaxel: 200 mg/m2 IV, Q3W Carboplatin: AUC 5 o 6, Q3W Nivolumab: 360 mg IV, Q3W Ipilimumab: 1mg/kg IV, Q6W Maintenance: following two cycles of chemo-immunotherapy the patients will receive: Nivolumab: 360 mg IV, Q3W Ipilimumab: 1mg/kg IV, Q6W Immunotherapy will be administered until disease progression, unacceptable toxicity, loss of clinical benefit or up to a maximum of 2 years of treatment.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy
Intervention Description
Patients will receive Ipilimumab 1mg/Kg administered by IV infusion every 42 days (Q6W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment. Structure: is a fully human monoclonal antibody with two heavy chains and two kappa light chains linked together by way of disulfide bonds. The molecular weight is approximately 148 kDa and it exists in solution at a physiologic pH of 7.0. Route of administration: Intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo
Intervention Description
Patients will receive Nivolumab 360 mg administered by IV infusion every 21 days (Q3W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment. Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains. Route of administration: Intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Patients will receive Carboplatin AUC 5 or 6 administered by IV infusion every 21 days (Q3W), for 2 cycles. Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) platin. Stability: 24 hours at ambient temperature in 5% glucose, glucosa or physiologic saline. It is recommended not to dilute with chlorinated solutions since this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Cis-diamminedichloroplatinum, Platinol
Intervention Description
Patients will receive Cisplatin 75mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles. Structure: (CAS No. 15663-27-1, MF-Cl2H6N2Pt; NCF-119875), cisplatinum, also called cis-diamminedichloroplatinum(II), is a metallic (platinum) coordination compound with a square planar geometry. It is a white or deep yellow to yellow-orange crystalline powder at room temperature. Stability: Do not store above 25°C. Do not refrigerate or freeze. Keep container in the outer carton to protect from light. Following dilution in 0.9% sodium chloride injection, chemical and physical in-use stability has been demonstrated for up to 14 days at 20°C. Route of administration: Intravenous infusion. Guidelines of Cisplatin administration: According to the standard of each center.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Patients will receive Paclitaxel 200mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles. Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-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 of 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.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Pemetrexed disodium; ALIMTA
Intervention Description
Patients will receive Pemetrexed 500mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles. Structure: Pemetrexed disodium (ALIMTA®, pemetrexed) is a novel pyrrol [2,3 d]-pyrimidine based folic acid analogue. Route of administration: Intravenous infusion. Guidelines of Pemetrexed administration: According to the standard of each center
Primary Outcome Measure Information:
Title
Rate of intracranial clinical benefit
Description
Defined as the percentage of patients who had lack of radiological or clinical progression for at least 6 months according to RANO-BM assessment criteria
Time Frame
From the date of the end of treatment until the date of last follow up, assessed up to 24 months
Secondary Outcome Measure Information:
Title
To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS)
Description
PFS defined as systemic PFS (excluding CNS) as per RECIST version 1.1 and PFS in the CNS as per RANO-BM criteria
Time Frame
From the date of the end of treatment until the date of last follow up, assessed up to 24 months
Title
To evaluate the Overall Response Rate (ORR) of the treatment
Description
Intracranial ORR, defined as a complete response or partial response as determined by the investigator according to RANO for brain disease. Systemic ORR, defined as a complete response or partial response as determined by the investigator according to RECIST v1.1. criteria for systemic disease.
Time Frame
From the date of the end of treatment until the date of last follow up, assessed up to 24 months
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
Time Frame
From the subject's written consent to participate in the study through 100 days after the final administration of the drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COHORT A Patients with histologically or cytologically confirmed stage IV NSCLC who did not receive any prior systemic therapy for advanced disease and have synchronous untreated brain metastases which does not cause neurologic symptoms and does not require systemic corticosteroid treatment within 10 days before initiating study treatment (controlled seizures with antiepileptic drugs should be allowed). COHORT B Patients with histologically or cytologically confirmed stage IV NSCLC who did not receive any prior systemic therapy for advanced disease and have synchronous brain metastasis causing neurologic signs and symptoms controlled with medium-low doses of corticosteroids (≤ 25mg/d of prednisone or ≤ 4mg/d of dexamethasone) but have good performance status (ECOG PS0-1). At least one untreated brain lesion in patients who already received focal radiotherapy (stereotactic focal radiotherapy) of prior brain lesions are eligible if novel brain lesions appear which are measurable and not suitable for focal radiotherapy.3. Patients with early or locally advanced NSCLC who have recurred after 6 months of completing adjuvant or neoadjuvant chemotherapy and have brain metastases are also eligible ECOG performance status 0-1 Patients aged ≥ 18 years Systemic measurable disease by computed tomography (CT) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria and brain measurable disease by magnetic resonance imaging (MRI) per RANO-BM criteria. Availability of a formalin-fixed paraffin-embedded block containing tumor tissue or 10 unstained slides. Archival tumor tissue can be sent if it was obtained less than 12 months ago. Correct hematological, hepatic and renal function. i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 ×109/L iii. Hemoglobin ≥ 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 45 mL/min (if using the Cockcroft-Gault formula below): a. Female CrCl = (140 - age in years) x weight in kg x 0.85/ 72 x serum creatinine in mg/dL b. Male CrCl = (140 - age in years) x weight in kg x 1.00/ 72 x serum creatinine in mg/dL v. AST/ALT ≤ 3 x ULN. Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 x ULN) vii. PT/APTT ≤ 1.5 × upper limit of normal (ULN). This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements Patients must be accessible for treatment and follow-up 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 3 days before randomization. All sexually active men and women of childbearing potential must use a highly effective contraceptive method (<1% failure rate) during the study treatment and for a period of at least 5 months for females and 7 months for males following the last administration of trial drugs. Exclusion Criteria: Patients with a history of other malignant diseases within the past 3 years, with the exception of the following: properly treated non-melanotic skin cancer cancer in situ treated with curative intent nonmuscular propria invasive carcinoma of the bladder or other malignancies treated with curative intent and without signs of disease for a period of > 3 years after the end of the treatment and which, in the opinion of the physician in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease. Patients harboring epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) and ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma Patients that received live attenuated vaccines within 30 days prior to randomization Leptomeningeal carcinomatosis or metastases in the brain stem, mid-brain, pons, medulla or causing obstructive hydrocephalus Single exclusive brain metastasis amenable to surgical treatment or radiosurgery Prior surgical resection of brain or spinal lesions in the prior 28 days Patients who have received prior neoadjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to be enrolled Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of radiation pneumonitis put of the radiation field on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. Significant comorbidities that preclude the administration of chemotherapy according to the investigator's criteria Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative) Previous treatment with immune checkpoint inhibitors Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction in the previous year or ventricular cardiac arrhythmias that require medication, history of atrioventricular conduction of second or third degree) Pregnant or breastfeeding women History of allergy or hypersensitivity to any of the study drug components Patients with a condition other than brain metastases requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Pereira
Phone
934302006
Email
gecp@gecp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest Nadal, MD
Organizational Affiliation
Fundación GECP Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO Badalona, Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ainhoa Hernández, MD
First Name & Middle Initial & Last Name & Degree
Ainhoa Hernández, MD
Facility Name
ICO Hospitalet
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernest Nadal, MD
First Name & Middle Initial & Last Name & Degree
Ernest Nadal, MD
Facility Name
Hospital Provincial de Castellón
City
Castelló de la Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Sánchez, MD
First Name & Middle Initial & Last Name & Degree
Alfredo Sánchez, MD
Facility Name
Hospital Universitario Insular de Gran canaria
City
Las Palmas De Gran Canaria
State/Province
Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delvys Rodriguez, MD
First Name & Middle Initial & Last Name & Degree
Delvys Rodriguez, MD
Facility Name
Hospitalario Universitario A Coruña
City
A Coruña
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosario García Campelo, MD
First Name & Middle Initial & Last Name & Degree
Rosario García Campelo, MD
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Franco, MD
First Name & Middle Initial & Last Name & Degree
Fabio Franco, MD
Facility Name
Hospital Universitari Vall d' Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Iranzo, MD
First Name & Middle Initial & Last Name & Degree
Patricia Iranzo, MD
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés Barba, MD
First Name & Middle Initial & Last Name & Degree
Andrés Barba, MD
Facility Name
Hospital Universitario de Jaén
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Laura Ortega Granados, MD
First Name & Middle Initial & Last Name & Degree
Ana Laura Ortega Granados, Md
Facility Name
Hospital Universitario de León
City
León
ZIP/Postal Code
24071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Diz, MD
First Name & Middle Initial & Last Name & Degree
Pilar Diz, MD
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Vázquez, MD
First Name & Middle Initial & Last Name & Degree
Sergio Vázquez, MD
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Dómine, MD
First Name & Middle Initial & Last Name & Degree
Manuel Dómine, MD
Facility Name
Hospital 12 De Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Paz-Ares, MD
First Name & Middle Initial & Last Name & Degree
Luis Paz-Ares, MD
Facility Name
Hospital Universitario Regional de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra Cantero, MD
First Name & Middle Initial & Last Name & Degree
Alejandra Cantero, MD
Facility Name
Hospital Universitari Son Llatzer
City
Palma De Mallorca
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Garcia, MD
First Name & Middle Initial & Last Name & Degree
Francisco Javier Garcia, MD
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Blasco, MD
First Name & Middle Initial & Last Name & Degree
Ana Blasco, MD
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Juan-Vidal, MD
First Name & Middle Initial & Last Name & Degree
Oscar Juan-Vidal, MD
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael López, MD
First Name & Middle Initial & Last Name & Degree
Rafael López, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.gecp.org
Description
Web page of the sponsor where users can find more information about Fundación GECP studies

Learn more about this trial

Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases

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