Non Small Cell Lung CancerNIVEXNCT03132493
Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient
An observational study of Non Small Cell Lung Cancer, run by Spanish Lung Cancer Group at 61 sites in Spain.
Trial summary
The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab. A standard anonymous data collection form will be used to collect data and to analyze it. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Nivolumab 10 MG/ML
- Type of treatment
- Injection or infusion
- How many people
- 676 participants
- Where
- 61 sitesSpain
- Study dates
- 1 Jun 2017to 15 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients eligible for the trial are those treated in the EAP of nivolumab in Spain. The total number of patients to be included will be 1400 from 150 participating sites in Spain (anticipated data)
Who may be able to join
- Squamous or Non-Squamous, non small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), relapsed after 1 prior platinum-based systemic treatment and who received treatment within the SPANISH expanded access programme of nivolumab (EAP)
- Alive patients must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care
Who cannot join
- Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form
- Patients who were accepted in the EAP but do not receive treatment
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
Spain61 sites
Centro Oncológico de Galicia
A Coruña, La Coruña, 15009
Hospital Universitario a Coruña
A Coruña, 15006
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital Virgen de los Lirios
Alcoy, Alicante, 03804
H. Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital del Mar
Barcelona, 08003
Hospital Vall d' Hebron
Barcelona, 08035
H. Universitario Quirón Dexeus
Barcelona, 08036
Hospital de Sant Pau Y de La Santa Creu
Barcelona, 08036
H. Althaia
Barcelona, 08243
Hospital de Basurto
Bilbao, Vizcaya, 48013
Hospital Virgen de la Luz
Cuenca, 16002
Hospital Universitario de Donostia
Donostia / San Sebastian, Gipuzkoa, 20014
Hospital de Elche
Elche, Alicante, 03202
Hospital Universitario de Vinalopó
Elche, Alicante, 03293
Hospital General Universitario de Elda
Elda, Alicante, 03600
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital de Galdakao
Galdakao, Bizkaia, 48960
Hospital Dr. Josep Trueta
Girona, 17007
Hospital Clínico San Cecilio
Granada, 18012
Hospital de Guadalajara
Guadalajara, 19002
Complejo Hospitalario de Jaén
Jaén, 23007
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas
Hospital Severo Ochoa
Leganés, Madrid, 28911
Complejo Asistencial Universitario de León
León, 24071
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital General Universitario Gregorio Marañón
Madrid, 28007
MD Anderson Cancer Center
Madrid, 28033
H.U. Puerta de Hierro
Madrid, 28035
Fundación Jimenez Diaz
Madrid, 28040
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Infanta Sofía
Madrid, 28703
H. Carlos Haya
Málaga, 29010
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital de Mataró
Mataró, Barcelona, 08304
Hospital Universitario de Móstoles
Móstoles, Madrid, 28935
H. Morales Messeguer
Murcia, 30008
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Son Espases
Palma de Mallorca, 07010
H. Son Llàtzer
Palma de Mallorca, 07198
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Infanta Cristina
Parla, Madrid, 28981
Hospital Universitario Quirón Madrid
Pozuelo de Alarcón, Madrid, Madrid
Hospital Sant Joan de Reus
Reus, Tarragona, 43204
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208
Hospital Clinico de Salamanca
Salamanca, 37007
Hospital Nuestra Señora Candelaria
Santa Cruz de Tenerife, 38010
Hospital Virgen del Rocío
Seville, 41013
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08220
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, 08221
Instituto Valenciano de Oncología
Valencia, 46009
Hospital General de Valencia
Valencia, 46014
Hospital Dr. Peset
Valencia, 46017
Hospital de Sagunto
Valencia, 46500
Hospital La Fe
Valencia
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Hospital Universitario de Áraba
Vitoria-Gasteiz, Áraba, 01009
Hospital Lluís Alcanyís
Xàtiva, Valencia, 46800
H. Miguel Servet
Zaragoza, 50009
About this study
Official title: A Retrospective, Multicenter and Observational Study of Nivolumab Monotherapy Treatment in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV NSCLC Within the Expanded Access Program (EAP) in SPAIN
The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab.
A standard anonymous data collection form will be used to collect data and to analyze it.
Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab.
Read the detailed description
This study will help to understand the efficacy of Nivolumab in the real world setting within the SPANISH expanded access programme.
The main objective of this study is to evaluate nivolumab efficacy in terms of Overall Survival (OS), Progression Free Survival (PFS), Overall Response Rate (ORR) and safety in the clinical practice.
The efficacy variables will be assessed for patients (squamous vs non-squamous) who received second line therapies or third lines and subsequent lines and also, long responders will be evaluated.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Nivolumab 10 MG/ML
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab 10 MG/MLDrug
Also called Opdivo
nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free survival
time from inclusion to progression
Measured: At 12 months
Secondary outcomes (1)
Overall Response rate
Percentage of patient reaching a complete, partial or stable disease
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Jun 2017
- Primary completion1 Dec 2017
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Lung Cancer Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delvys Rodríguez, MD, PhD, Principal investigator, Hospital Universitario Insular de Gran CanariaMargarita Majem, MD, PhD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132493
- Sponsor's protocol ID
- GECP 16/05_NIVEX
- Acronym
- NIVEX
- Status last verified
- Nov 2018
- First submitted
- 25 Apr 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multicenter and Observational Study of Nivolumab Monotherapy Treatment in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV NSCLC Within the Expanded Access Program (EAP) in SPAIN
- ClinicalTrials.gov ID
- NCT03132493
- Acronym / sponsor ID
- NIVEX / GECP 16/05_NIVEX
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- Spanish Lung Cancer GroupUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will be retrospectively review the case note of patients registered in the EAP of Nivolumab.
A standard anonymous data collection form will be used to collect data and to analyze it.
Patients with advanced Non-Small Cell Lung Cancer previously treated and included in the SPANISH expanded access programme of nivolumab.
Detailed description
This study will help to understand the efficacy of Nivolumab in the real world setting within the SPANISH expanded access programme.
The main objective of this study is to evaluate nivolumab efficacy in terms of Overall Survival (OS), Progression Free Survival (PFS), Overall Response Rate (ORR) and safety in the clinical practice.
The efficacy variables will be assessed for patients (squamous vs non-squamous) who received second line therapies or third lines and subsequent lines and also, long responders will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients eligible for the trial are those treated in the EAP of nivolumab in Spain. The total number of patients to be included will be 1400 from 150 participating sites in Spain (anticipated data)
Key inclusion criteria (2 listed)
- Squamous or Non-Squamous, non small cell lung cancer (NSCLC), Stage IIIb/IV (histologically or cytologically confirmed), relapsed after 1 prior platinum-based systemic treatment and who received treatment within the SPANISH expanded access programme of nivolumab (EAP)
- Alive patients must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care
Key exclusion criteria (2 listed)
- Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form
- Patients who were accepted in the EAP but do not receive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab 10 MG/MLAlso: Opdivonivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression | Drug | – |
Primary outcome
Progression Free survival
Time frame: At 12 months
time from inclusion to progression
1 secondary outcome
Overall Response rate
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delvys Rodríguez, MD, PhD principal investigator
Hospital Universitario Insular de Gran Canaria
Margarita Majem, MD, PhD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Spanish Lung Cancer Group at 61 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free survival (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.