PUBLICACIONES

ANNEX I. CLINICAL TRIALS FROM 2015
EARLY STAGES

• LINC
(BR.31)

A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer.
NCT02273375

• NADIM
(GECP 16/03)

Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients
NCT03081689

• NADIM II
(GECP 18/02)

A Randomized Phase II Study of Neo-adjuvant Chemo/Immunotherapy Versus Chemotherapy Alone for the Treatment of Locally Advanced and Potentially Resectable Non-small Cell Lung Cancer (NSCLC) Patients.
NCT03838159

• NADIM ADJUVANT
(GECP 20/05)

A Phase III Clinical Trial of Adjuvant Chemotherapy vs Chemoimmunotherapy for Stage IB-IIIA Completely Resected Non-small Cell Lung Cancer (NSCLC) Patients.
NCT04564157

LOCALLY ADVANCED STAGES

• NORA
(GECP 15/02)

Phase II Clinical Trial With Metronomic Oral Vinorelbine and Tri-weekly Cisplatin as Induction Therapy and Subsequent Concomitantly With Radiotherapy (RT) in Patients With Lung Cancer (NSCLC) Locally Advanced Unresectable.
NCT02709720

• Neo-DIANA
(GECP 20/01)

A Phase II Trial of Neoadjuvant Treatment Carboplatin-Pemetrexed-Bevacizumab Plus Atezolizumab for the Treatment of Locally Advanced and Potentially Resectable NSCLC Patients With EGFR Mutations.
NCT04512430

• APOLO
(GECP 20/08)

A Phase II Trial of Atezolizumab Plus Induction Chemotherapy (CT) Plus Chemo-radiotherapy and Atezolizumab Maintenance Therapy in Non-resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) Patients.
NCT04776447

• MERIT-lung
(GECP 20/10)

Phase II Clinical Trial of AMG510 (Sotorasib) in Stage III Unresectable NSCLC KRAS p.G12C Patients and Medically Ineligible for Concurrent Chemo-radiotherapy.
NCT05398094

• BOUNCE
(ETOP 21-21)

A Multicentre, Randomised, Phase II Trial of Brigatinib Consolidation Versus Observation or Durvalumab in Patients With Unresectable Stage III NSCLC and ALK-rearrangement, After Definitive Chemo-radiotherapy.
NCT05718297

ADVANCED STAGES. WITH DRIVER

• CUBIK
(GECP 19/01)

Clinical Utility of Liquid Biopsy as a Tool to Assess the Evolution of Brigatinib Treated Patients With Non-small Cell Lung Cancer With EML4-ALK Translocation: an Exploratory Study.
NCT04223596

• THOMAS
(GECP 17/04

An Open Label Phase II Study of Tipifarnib in Advanced Squamous Non-small Cell Lung Cancer With HRAS Mutations.
NCT03496766

• BOOSTER
(ETOP 10-16)

A Randomised Phase II Trial of Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M.
NCT03133546

• ABC-Lung
(ETOP 15-19)

A Randomised Non-comparative Open Label Phase II Trial of Atezolizumab Plus Bevacizumab, With Carboplatin-paclitaxel or Pemetrexed, in EGFR-mutant Non-small Cell Lung Carcinoma With Acquired Resistance.
NCT04245085

• STEREO
(ETOP 17-20)

A Multicentre Single-arm Phase II Trial Assessing the Safety and Efficacy of First-line Osimertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer.
NCT04908956

• AMAZE-lung
(ETOP 18-21)

A Multicentre Single-arm Phase II Trial of Amivantamab, Lazertinib Plus Bevacizumab in Patients With EGFR-mutant Advanced NSCLC With Progression on Previous Third-generation EGFR-TKI.
NCT05601973

• ADEPPT
(ETOP 22-22)

A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status.
NCT05673187

• PEBEL
(GECP 16/06)

Survival, Quality of Life and Self-reported Outcomes of Elderly Patients With Advanced Non-small Cell Lung Cancer Treated With Pembrolizumab (MK-3475) in the First Line Setting.
NCT03293680

• NVALT
(NVALT-15)

Phase II study with BIBF1120, an oral fibroblast growth factor 1 inhibitor, as second-line treatment in patients with non-small cell lung cancer and fibroblast growth factor receptor 1 gene amplification (NVALT-15).

• ALERT-Lung
(ETOP 12-17)

A Single Arm Phase II Trial Evaluating the Activity of Alectinib for the Treatment of Pretreated RET-rearranged Advanced NSCLC.
NCT03445000

ADVANCED STAGES. WITHOUT DRIVERS

• TELMA
(GECP 18/03

A Phase II Open Label Study of Atezolizumab in Combination With Bevacizumab as First Line Treatment for Locally Advanced or Metastasic High-intermediate Tumor Mutation Burden Selected Non-squamous Non-small Cell Lung Cancer Patients.
NCT03836066

• ETOP-CHESS
(ETOP 14-18)

A Multicentre Single Arm Phase II Trial Assessing the Efficacy of Immunotherapy, Chemotherapy and Stereotactic Radiotherapy to Metastases Followed by Definitive Surgery or Radiotherapy to the Primary Tumour, in Patients With Synchronous Oligo-metastatic Non-small Cell Lung Cancer.
NCT03965468

• NIVIPI BRAIN
(GECP 21/02)

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.
NCT05012254

• REPLAY
(GECP 17/02)

A Phase II Open-label Multicenter Exploratory Study to Assess Efficacy of Pembrolizumab Re-challenge as Second or Further Line in Patients With Advanced Non – Small Cell Lung Cancer.
NCT03526887

• SPLENDOUR
(ETOP-5–12)

A Randomised, Open-label Phase III Trial Evaluating the Addition of Denosumab to Standard First-line Anticancer Treatment in Advanced NSCLC
NCT02129699

• PIPSeN
(CSET2014/2204_PIPSeN)

A Randomized Double-blind Phase II Trial Evaluating Maintenance Olaparib Versus Placebo in Patients With Platinum-sensitive Advanced Non-small Cell Lung Cancer.
NCT02679963

• DURVAST
(GECP 16/04)

Phase II clinical study of Durvalumab (MEDI4736) in HIV-1 (Human Immunodeficiency Virus-1) positive patients with advanced solid tumors.
NCT03094286

• NIVEX
(GECP 16/05)

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.
NCT03132493

• ATEZO- BRAIN
(GECP 17/05)

Phase II Non-randomized Study of a Atezolizumab (MPDL3280A) in Combination With Carboplatin Plus Pemetrexed in Patients Who Are Chemotherapy-naïve and Have Stage IV Non-squamous Non-small Cell Lung Cancer Twith Asymptomatic Brain Metastasis.
NCT03526900

SMALL CELL LUNG CANCER (SCLC) STUDIES

• BEAT-Meso

A Randomised Open-label Phase II Trial of Consolidation With Nivolumab and Ipilimumab in Limited-stage SCLC After Chemo-radiotherapy
NCT03762018

•PROMISE-Meso
(Mesothelioma)

A Phase II Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer (ES-SCLC).
NCT02991482

•BIMES (Mesothelioma)

A Single-arm Phase II Trial of the Addition of Niraparib to Anti-PD-L1 Antibody Maintenance in Patients With SLFN11-positive, Extensive-disease Small Cell Lung Cancer.
NCT05005429

OTHER LUNG TUMORS STUDIES

•BEAT-Meso
(Mesothelioma)
(ETOP 13-18)

A Multicentre Randomised Phase III Trial Comparing Atezolizumab Plus Bevacizumab and Standard Chemotherapy Versus Bevacizumab and Standard Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma.
NCT03762018

•PROMISE-Meso
(Mesothelioma)
(ETOP 9-15)

A Multicentre Randomised Phase III Trial Comparing Pembrolizumab Versus Standard Chemotherapy for Advanced Pre-treated Malignant Pleural Mesothelioma.
NCT02991482

•BIMES (Mesothelioma)
(GECP 20/09)

A Phase II Single Arm Clinical Trial Assessing the Efficacy and Safety of BIntrafusp Alfa (M7824) in Previously Treated Advanced Malignant Pleural MESothelioma (BIMES).
NCT05005429

•DUMAS (Pancoast)
(GECP 22/02)

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.
NCT05684276

EPIDEMIOLOGICAL STUDIES

•VAC-CaP
(GECP 21/01)

Observational Study on the Effectiveness and Safety of Vaccination Anti-SARS-CoV2 in Patients With Lung Cancer.
NCT05009030

•Thoracic Tumor Registry (TTR)
(GECP 16/01)

Thoracic Tumours Register
NCT02941458

Substudy: TTR-ATLAS
A Spanish Nationwide Biomarker NGS Testing Platform For Lung Cancer.

Substudy: TTR-ATLAS-RADON
Radon Measurement In Homes Of Lung Cancer Patients.

•OSIREX
(GECP 18/01)

A Retrospective, Multicenter and Observational Study of Osimertinib Monotherapy Treatment in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer EGFR-T790M Mutation-positive Who Have Received the Treatment Within the Special Use Medication Program in Spain.
NCT03790397

•SOLID
(GECP 20/04)

Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection (SOLID).

NCT04407143

Substudy: SOLID I
The scope is the identification of acquired immunity (IgG) in patients with lung cancer, whether or not they have presented symptoms of having suffered from COVID19. In addition, the description of the characteristics and evolution of patients with lung cancer who have contracted COVID-19 infection will be carried out.

Substudy: SOLID II
The scope is the confirmation of the presence of antibodies (IgG) in patients who tested positive in Phase I of the study a few weeks after the first diagnosis made through the SOLID study.

Substudy: SOLID III
The scope is the confirmation of the presence of antibodies (IgG) in patients with lung cancer who have been vaccinated with any of the available and authorized vaccines for SARS-COV2 and 6 months after said administration.

•GRAVID
(GECP 20/02)

Observational Retrospective Register of Spanish Lung and Melanoma Cancer Patients With COVID19 Disease.
NCT04344002

PHARMACOGENOMIC STUDIES

•SELINA
(GECP 16/02)

Analysis of Soluble Mediators, Cytokines, and Circulating Angiogenic Factors (FACs) as Potential Predictors / Prognostic Factors in Antiangiogenic Therapy Following Failure of First-line Chemotherapy in Advanced Non-squamous Lung Carcinoma.
NCT03156868

•REAL NADIM
(GECP 21/05)

Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment.
NCT05382052

•RING project
(GECP 17/03)

T790M Mutation Testing in Blood by Different Methodologies.
NCT03363139

OBSERVATIONAL STUDIES

•S-REAL
(GECP 19/02)

First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy.
NCT03798535

•LORLAPULM
(GECP 21/04)

Retrospective, Observational Study On The Efficacy And Safety Of Lorlatinib In ALK or ROS1 Metastatic Non-Small Cell Lung Cancer Patients Treated Within The Compassionate Use Program In Spain.
NCT05167500

•PLANET
(GECP 21/03)

Retrospective, Observational Study On The Efficacy And Safety Of Lorlatinib In ALK or ROS1 Metastatic Non-Small Cell Lung Cancer Patients Treated Within The Compassionate Use Program In Spain.
NCT05167487

•LUDICAS
(GECP 23/01)

Characteristics of Sexual Dysfunction in Lung Cancer Patients
NCT06018376

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