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Clinical trials group

What is the importance of clinical trials to our patient?

Clinical trials are the possibilities for our doctors to be involved in research of new possible medical agents and for our patients to take a few steps forward and get the most novel treatment before it becomes available.

Clinical trials is priority oncology area, which ensure the emergence of new effective medicines, biomarker research, and justification of medical methodologies by evidence and science. More than 20 phase II, phase III, and phase IV clinical trials, involving approximately 100 patients and 15% of institute staff, are performed in National Cancer Institute every year. Clinical trials of various localizations solid tumors are performed; but the most common are in the areas of breast, prostate, lung, stomach, pancreas and head-neck tumors. Phase I clinical trials will be started in the near future.

Working in the area of clinical trials for more than 15 years, we managed to create the clinical trials coordination structure involving the professional and skilled staff. This allows us to ensure high quality implementation of clinical trials, following the guidelines for good clinical practice. All implemented clinical trials are approved by the Lithuanian Bioethics Committee and the State Medicines Control Agency.

Currently, 24 clinical trials are performed in the Institute; 8 of them are actively recruiting patients.

We have the possibility to carry out trials of all phases, from I to IV, in the Institute.


List of clinical trials

 

 

Localization

 

Name of the study

 

Investigators group

 

The state of the study

 

Start of the study

 

End of the study

NON-SMALL CELL LUNG CANCER

FIOL

„First-line treatment with osimertinib in EGFR-mutated non-small cell lung cancer, coupled to extensive translational studies“

 

Principal investigator:
S. Cicėnas

Other investigators:
V. Gedvilaitė

Inclusion of patients

04-Apr-2019

2021

MELANOMA

CDRB436F2410

„Open-label, phase IIIb study of dabrafenib in COMBInation with trametinib in the Adjuvant treatment of stage III BRAF V600 mutation-positive melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm (Plus)“

Principal investigator:
B. Brasiūnienė

Other investigators:
N. Lachej
V. Urbonas

Inclusion of patients

03-Oct-2018

Oct-2021

PROSTATE ADENOCARCINOMA

UROLUD-4

„A prospective observational study of patients with a confirmed diagnosis of adenocarcinoma of the prostate presenting with metastatic castrate-resistant prostate cancer“

Principal investigator:
A. Ulys

Other investigators:
J. Asadauskienė
A. Patašius
A.  Zykus
S. Žilys

Inclusion of patients

25-Apr-2018

2020

NON-SMALL CELL LUNG CANCER

BGB-A317-303

„A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti−PD1 Antibody) Compared with Docetaxel in Patients with Non−Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen“

Principal investigator:
S. Cicėnas

Other investigators:
V. Gedvilaitė
A. Cicėnienė
L. Norkienė

Inclusion of patients

05-Dec-2018

2021

BREAST CANCER

CLEE011A2207

„A phase II, multicenter, randomized, open-label study to evaluate the safety and efficacy of dosing regimens of ribociclib in combination with non-steroidal aromatase inhibitors for the treatment of pre- and postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer who received no prior therapy for advanced disease“

Principal investigator:
L. Daukantiene

Other investigators:
E. Baltruškevičienė
M. Drobnienė

 

Inclusion of patients

30-May-2019

2026

COLORECTAL CANCER

CL3-95005-006

„An open-label, randomised, phase III Study cOmparing trifLuridine/tipiracil (S 95005) in combination with bevacizumab to capecitabine in combination with bevacizumab in firST-line treatment of patients with metastatIC colorectal cancer who are not candidatE for intensive therapy (SOLSTICE study)“

Principal investigator:
E. Baltruškevičienė

Other investigators:
L. Daukantienė
A. Cicėnienė

Inclusion of patients

10-Jun-2019

2022

NON-SMALL CELL LUNG CANCER

R2810-ONC-16111

„A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 ≥50%“

Principal investigator:
S. Cicėnas

Other investigators:
V. Gedvilaitė
A. Cicėnienė
L. Norkienė

Patient treatment

 

16-Jul-2018

Nov-2020

NON-SMALL CELL LUNG CANCER

R2810-ONC-16113

„A Randomized, Phase 3, Open-label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 <50%“

Principal investigator:
S. Cicėnas

Other investigators:
V. Gedvilaitė
A. Cicėnienė
L. Norkienė

Patient treatment

 

16-Jul-2018

Feb-2023

PROSTATE CANCER

LPC-004

„A Single Blind, Two-Stage Dose Finding Study to Evaluate the Safety, Tolerability and Efficacy of a Single Liproca® Depot Injection into the Prostate in Patients with Localized Prostate Cancer, Assigned to Active Surveillance who are at High Risk for Disease Progression (followed by an Open Label Extension with a Repeat Injection (Optional))“

Principal investigator:
A.Ulys

Other investigators:
Ž. Kardelis
D. Šlaitas

 

Patient treatment

 

05-Nov-2018

2019

GEP NET

Nr. A-99-52030-286

“Exploratory, non-interventional study for evaluating the diagnostic, prognostic and response-predictive value of a multi biomarker approach in metastatic GEP NETs”

Principal investigator:
E. Baltruškevičienė

Patient treatment

 

09-Mar-2016

Dec-2021

URINARY TRACT CARCINOMA

MO29983

„An open label, single arm, multicenter, safety study of atezolizumab in locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract“

Principal investigator:
B. Brasiūnienė

Other investigators:
J. Asadauskienė
L.Norkienė

Patient treatment

 

29-Mar-2017

31-May-2022

BREAST CANCER

MO28047

„A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer.“

Principal investigator:
M. Drobnienė

Other investigators:
L. Daukantienė

Patient treatment

04-Nov-2013

28-Sep-2019

BREAST CANCER

M12-914

„A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer.“

Principal investigator:
V. Ostapenko

Other investigators:
J. Asadauskienė

Patient treatment

 

21-Nov-2014

28-Apr-2020

PROSTATE CANCER

3104007

„A Multinational Randomised, Double- Blind, Placebo-Controlled, Phase III Efficacy And Safety Study Of ODM-201 In Men With High-Risk Non-Metastatic Castration-Resistant Prostate Cancer.“

Principal investigator:
A. Ulys

Other investigators:
Ž. Kardelis
D. Šlaitas
T. Česiulienė

Patient treatment

05-Oct-2015

2022

NON-SMALL CELL LUNG CANCER

TREM

„AZD9291, an irreversible EGFR-TKI, in relapsed EGFR-mutated non-small cell lung cancer patients previously treated with an EGFR-TKI, coupled to extensive translational studies.“

Principal investigator:
S. Cicėnas

Other investigators:
R. Aškinis

Patient treatment

28-Dec-2015

Dec-2021

PANCREATIC CANCER

HALO-109-301

“A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab‑Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab‑Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma.”

Principal investigator:
E. Baltruškevičienė

Other investigators:
N. Lachej

Observation of patients

28-Jul-2016

31-Dec-2019

SMALL CELL LUNG CANCER

M16-298

„A Randomized, Double-Blind, Placebo-Controlled Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)“

Principal investigator:
B. Brasiūnienė

Other investigators:
L. Norkienė
V. Gedvilaitė

Observation of patients

16-Jan-2018

22-Sep-2022

GASTRIC OR GASTROESOPHAGEAL JUNCTION (GEJ) ADENOCARCINOMA

MK-3475-062

„A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.“

Principal investigator:
E. Baltruškevičienė

Other investigators:
N. Lachej

Observation of patients

19-May-2016

06-Jun-2020

NON-SMALL CELL LUNG CANCER

1199.223

„A non-interventional biomarker study in patients with Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma tumour histology eligible for treatment with Vargatef® according to the approved label“

Principal investigator:
S. Cicėnas

Other investigators:
V. Gedvilaitė
R. Aškinis

Observation of patients

28-Aug-2017

2019

SMALL CELL LUNG CANCER

DIV-SCLC-301

„A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer“

Principal investigator:
S. Cicėnas 

Other investigators:
V. Gedvilaitė
A. Cicėnienė
L. Norkienė

Observation of patients

 

26-Feb-2018

Nov-2019

BREAST CANCER

EGF106903

„A randomised, multicentre, open-label, phase III study of neoadjuvant lapatinib, trastuzumab, and their combination plus paclitaxel in women with HER2/ErbB2 positive primary breast cancer“

Principal investigator:
A. Cicėnienė

Other investigators:
A. Lukšytė
S. Bružas
M. Trakymas

Observation of patients

 

Oct-2007

Dec-2019

BREAST CANCER

3144A2-3004-WW

„A Randomized Double-blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast Cancer“

Principal investigator:
A. Cicėnienė

Other investigators:
L. Daukantienė
E. Baltruškevičienė

Observation of patients

 

30-Oct-2009

2020

NON-SMALL CELL LUNG CANCER

MK-3475-042

„A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) versus Platinum Based Chemotherapy in Treatment Naïve Subjects with PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042).“

Principal investigator:
S. Cicėnas

Other investigators:
R. Aškinis
A. Cicėnienė

Observation of patients

06-Nov-2014

06-Mar-2021

PROSTATE CANCER

SP005

„A Randomized, Double Blind, Multicenter, Parallel-group, Phase III study to evaluate efficacy and safety of DCVAC/PCa versus Placebo in Men with metastatic Castration Resistant Prostate Cancer eligible for 1st line chemotherapy.“

Principal investigator:
J. Asadauskienė

Other investigators:
L. Steponavičienė

Observation of patients

22-Sep-2015

Jun-2020

NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

GO29436

„A phase 3, open-label, randomized study of mpdl3280a (anti-pd-l1 antibody) in combination with carboplatin - paclitaxel with or without bevacizumab compared with carboplatin -paclitaxel - bevacizumab in chemotherapy naïve patients with stage iv non-squamous non-small cell lung cancer.“

Principal investigator:
S. Cicėnas

Other investigators:
R. Aškinis
A. Cicėnienė
L. Norkienė

Observation of patients

08-Dec-2015

Dec-2019

MELANOMA

CDRB436B2404

„Describe III: Retrospective chart review of dabrafenib monotherapy and/or dabrafenib-trametinib combination therapy in patients with metastatic melanoma to characterize patients with long term benefit in the Individual Patient Program (IPP)“

Principal investigator:
E. Baltruškevičienė

Data processing

12-Dec-2017

2019




Updated 2019-06-27 13:04