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Study of NOV-002 in Combination With Chemotherapy to Treat Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paclitaxel
NOV-002
Carboplatin
Sponsored by
Cellectar Biosciences, Inc.
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 NSCLC, Stage IIIb, Stage IV, Non Small Cell Lung Cancer (NSCLC), NSCLC Stage IIIb with malignant pleural/pericardial effusion, NSCLC Stage IV

Eligibility Criteria

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

Inclusion Criteria: Diagnosis of Stage IIIb with malignant pleural or pericardial effusion or Stage IV (American Joint Committee on Cancer [AJCC]) NSCLC ECOG performance score of 0 or 1 Adequate bone marrow, hepatic, and renal function New York Heart Association (NYHA) score 1-2 Life expectancy of at least 12 weeks Women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years). The patient or patient's legal representative has the ability to understand the requirements of the trial, has provided written informed consent, and agrees to abide by the trial restrictions and to return for the required assessments. The patient must be able to self administer daily subcutaneous injections or his/her caregiver must be able to administer daily subcutaneous injections. Exclusion Criteria: Prior chemotherapy for advanced NSCLC or the patient has received prior neoadjuvant or adjuvant chemotherapy for NSCLC in the year prior to the date of randomization Patients with central nervous system (CNS) metastases Any systemic disease precluding chemotherapy Chronic use of systemic corticosteroids in pharmacological doses Known or history of HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Contraindication to treatment with paclitaxel or carboplatin or any of the components of NOV-002 Any known preexisting medical condition, including substance abuse, that could interfere with the patient's participation in and completion of the protocol Have received any investigational drug, defined as a drug for which there is no Food and Drug Administration (FDA) approved indication, within the 30 days prior to randomization Pregnant female or nursing mother

Sites / Locations

  • Northwest Alabama Cancer Center
  • Sharp Memorial Hospital
  • University of Chicago Medical Center
  • Northern Indiana Cancer Research Consortium
  • St. Agnes Hospital
  • Massachusetts General Hospital
  • University of Minnesota Medical Center, Fairview
  • Park Nicollet Clinic - Cancer Center St. Louis Park
  • Dartmouth Hitchcock Medical Center
  • Cleveland Clinic Foundation Taussig Cancer Center
  • Thomas Jefferson University Hospital
  • South Texas Institute of Cancer
  • William Osler Health Center
  • Humber River Regional Hospital
  • Jewish General Hospital
  • Laval Hospital
  • Barzilai Medical Center
  • Lin Clinic
  • Meir Medical Center
  • Institute of Oncology
  • Sheba Medical Center
  • Assaf Harofeh Hospital
  • Azienda Ospedaliera Treviglio Caravaggio
  • Azienda Ospedaliera Careggi
  • Sondrio Hospital
  • Oddzial Pulmonologiczny z Pododdzialem Chemioterapii
  • Samodzielny Publiczny Szpital Kliniczny N°.1
  • Oddzial Chemioterapii Pomorskie Centrum Onkologii,
  • Katedra Onkologii Akademii Medycznej w Lodzi
  • Oddzial Chemioterapii Zaklad Opieki Zdrowotnej MSWiA
  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Oddzial III
  • Wielkopolskie Centrum Chorob
  • Oddzial Gruzlicy I Chorob Pluc I P
  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
  • S.C. Oncomed SRL
  • Institute of Oncology, Department of Medical Oncology II
  • Institute of Oncology Cluj-Napoca
  • Institute of Oncology, Cluj-Napoca
  • Craiova Emergency Clinical County Hospital
  • Arkhangelsk Regional Clinical Oncology Center
  • Chelyabinsk Regional Oncology Center, Chemotherapy Department
  • Clinical Oncology Center, Chemotherapy Department
  • Omsk Regional Clinical Oncology Center
  • Orenburg Regional Clinical Oncology Center
  • Stavropol Regional Clinical Oncology Center
  • Oncology Center, Hematology Department
  • Leningrad Regional Clinical Hospital, Department of Thoracic Surgery
  • City General Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery
  • St. Petersburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development
  • City Clinical Oncology Center, Thoracic Department
  • Stavropol Regional Clinical Oncology Center, Chemotherapy Department
  • Tambov Regional Oncology Center, Chemotherapy Department
  • Kazan Oncology Center
  • Voronezh Regional Clinical Oncology Center
  • Clinical Hospital Center Bezanijska kosa
  • Clinical Center Nis, Clinic for Lung Diseases "Knez Selo"
  • Institute of Lung Diseases Sremka Kamenica
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Mutua de Terrassa
  • Kantonales Spital Sursee-Wolhusen
  • Cherkasy Regional Oncology Center
  • Public Treatment and Prophylaxis Institution: Chernihiv Regional Oncology Center
  • City General Hospital #4
  • Regional Oncological Center
  • S.P. Grigoryev Institute of Medical Radiology
  • Oncology Institute under the Ukrainian Academy of Medical Sciences
  • Crimean Republican Clinical Oncology Center
  • Zakarpatsky Regional Oncological Clinical Center
  • Anchor Unit, Aberdeen Royal Infirmary
  • Ninewells Hospital and Medical School Department of Cancer Medicine
  • St. Luke's Cancer Centre
  • Oncology Research, Nottingham City Hospital
  • Dorset Cancer Centre, Poole Hospital
  • Yeovil District Hospital NHS Foundation Trust, Higher Kingston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: NOV-002 plus Chemotherapy

Group B: Chemotherapy Alone

Arm Description

NOV-002 in combination with Paclitaxel and Carboplatin

Paclitaxel and Carboplatin

Outcomes

Primary Outcome Measures

Overall survival during the length of the trial, length of the trial is approximately two years after last patient in

Secondary Outcome Measures

Improved progression-free survival (PFS)
Higher anti-tumor overall response rate (ORR)
Less myelosuppression and improved recovery from chemotherapy-induced myelosuppression
Immunomodulation as evidenced by changes in lymphocyte subsets

Full Information

First Posted
June 29, 2006
Last Updated
July 19, 2022
Sponsor
Cellectar Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00347412
Brief Title
Study of NOV-002 in Combination With Chemotherapy to Treat Lung Cancer
Official Title
Phase 3 Trial, Randomized, Open-Label, of NOV-002 in Combination With Paclitaxel and Carboplatin vs. Paclitaxel and Carboplatin Alone for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellectar Biosciences, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical trial is to find out whether or not the combination of NOV-002 with chemotherapy (paclitaxel and carboplatin) is better at improving overall survival time when compared to chemotherapy alone in people with non-small cell lung cancer (NSCLC). Earlier clinical trials in NSCLC showed that patients treated with NOV-002 in combination with chemotherapy had a better response (their tumors got smaller in one United States Phase 1/2 trial) than patients who received chemotherapy alone; and in two Phase 2 trials done in Russian patients, at the end of one year, patients treated with NOV-002 with chemotherapy had a better survival rate than patients who did not receive NOV-002 with their chemotherapy.
Detailed Description
NSCLC is a widespread disease with extremely high mortality and morbidity. Even the most widely accepted standard of care chemotherapy in advanced NSCLC, platinum-based doublets, are only palliative, providing marginal efficacy as measured by survival. In addition, such chemotherapy is accompanied by severe, sometimes life-threatening, toxicities which often limit its application. Thus, there is a clear need for new, more effective and safer therapies for advanced NSCLC. In Phase 2 trials, NOV-002 demonstrated a higher response rate and improved survival compared to chemotherapy alone in patients with advanced NSCLC, and was well-tolerated in this patient group. Thus, we are conducting a large Phase 3 trial of NOV-002 to better define its clinical profile and potential benefit in advanced NSCLC patients. The overall design of this Phase 3 trial reflects major elements of the previous Russian and US clinical trials in advanced NSCLC - it is an open label, randomized controlled trial comparing NOV-002 in combination with first-line chemotherapy (paclitaxel + carboplatin) to first-line chemotherapy alone. Furthermore, it is designed and powered to be a pivotal, registrational trial, sufficient for approval. As its primary efficacy endpoint, this Phase 3 trial aims to demonstrate that the combination of NOV-002 with paclitaxel and carboplatin results in improved overall survival when compared with paclitaxel and carboplatin alone. In addition, several secondary efficacy endpoints will be assessed, including progression free survival, tumor response rate and duration of response, quality of life, myelosuppression and immunomodulation. Overall survival was chosen as the primary endpoint of this trial in the context of FDA (Draft) Guidance ("Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics", April 2005). This Guidance indicates that an improvement in overall survival should be evaluated in randomized controlled trials and is of unquestioned clinical benefit. It indicates that the endpoint is precise and easy to measure, documented by the date of death, and states that bias is not a factor in endpoint measurement, and blinding is not essential. This Phase 3 randomized, controlled, open-label trial thus conforms to this Guidance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
NSCLC, Stage IIIb, Stage IV, Non Small Cell Lung Cancer (NSCLC), NSCLC Stage IIIb with malignant pleural/pericardial effusion, NSCLC Stage IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
903 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: NOV-002 plus Chemotherapy
Arm Type
Experimental
Arm Description
NOV-002 in combination with Paclitaxel and Carboplatin
Arm Title
Group B: Chemotherapy Alone
Arm Type
Active Comparator
Arm Description
Paclitaxel and Carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Abraxane, Onxol, Taxol
Intervention Description
Paclitaxel is dosed at 200 mg/m2, as a 3 hour infusion. All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first.
Intervention Type
Drug
Intervention Name(s)
NOV-002
Intervention Description
Two 60 mg intravenous boli given 3 hours apart administered the day prior to the first administration of paclitaxel and carboplatin cycle one For each nominal 21-day paclitaxel and carboplatin cycle: 60 mg given intravenously on Day 1, given one hour prior to paclitaxel and carboplatin followed by 60 mg subcutaneously daily for the next 20 days. If there is a delay in chemotherapy cycles, the patient will continue with daily, subcutaneous administration of NOV-002 until the next cycle of chemotherapy begins Patients randomized to NOV-002 Group A, will receive NOV-002 until disease progression, unacceptable NOV-002 related toxicity, or discontinuation of paclitaxel and carboplatin, whichever comes first.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Carboplatin is dosed at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing. All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first. The initial dose of chemotherapy for every patient in the trial is 200 mg/m2 of paclitaxel, as a 3 hour infusion, followed by carboplatin at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing.
Primary Outcome Measure Information:
Title
Overall survival during the length of the trial, length of the trial is approximately two years after last patient in
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Improved progression-free survival (PFS)
Time Frame
16 months
Title
Higher anti-tumor overall response rate (ORR)
Time Frame
16 months
Title
Less myelosuppression and improved recovery from chemotherapy-induced myelosuppression
Time Frame
16 months
Title
Immunomodulation as evidenced by changes in lymphocyte subsets
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Stage IIIb with malignant pleural or pericardial effusion or Stage IV (American Joint Committee on Cancer [AJCC]) NSCLC ECOG performance score of 0 or 1 Adequate bone marrow, hepatic, and renal function New York Heart Association (NYHA) score 1-2 Life expectancy of at least 12 weeks Women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years). The patient or patient's legal representative has the ability to understand the requirements of the trial, has provided written informed consent, and agrees to abide by the trial restrictions and to return for the required assessments. The patient must be able to self administer daily subcutaneous injections or his/her caregiver must be able to administer daily subcutaneous injections. Exclusion Criteria: Prior chemotherapy for advanced NSCLC or the patient has received prior neoadjuvant or adjuvant chemotherapy for NSCLC in the year prior to the date of randomization Patients with central nervous system (CNS) metastases Any systemic disease precluding chemotherapy Chronic use of systemic corticosteroids in pharmacological doses Known or history of HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Contraindication to treatment with paclitaxel or carboplatin or any of the components of NOV-002 Any known preexisting medical condition, including substance abuse, that could interfere with the patient's participation in and completion of the protocol Have received any investigational drug, defined as a drug for which there is no Food and Drug Administration (FDA) approved indication, within the 30 days prior to randomization Pregnant female or nursing mother
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lynch, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Panos Fidias, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Northwest Alabama Cancer Center
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
St. Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02144
Country
United States
Facility Name
University of Minnesota Medical Center, Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Park Nicollet Clinic - Cancer Center St. Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cleveland Clinic Foundation Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
South Texas Institute of Cancer
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78405
Country
United States
Facility Name
William Osler Health Center
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6W 2Z8
Country
Canada
Facility Name
Humber River Regional Hospital
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Facility Name
Laval Hospital
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
Facility Name
Lin Clinic
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Institute of Oncology
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Assaf Harofeh Hospital
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Azienda Ospedaliera Treviglio Caravaggio
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Azienda Ospedaliera Careggi
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Sondrio Hospital
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Oddzial Pulmonologiczny z Pododdzialem Chemioterapii
City
Bystra
ZIP/Postal Code
43-360
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny N°.1
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Oddzial Chemioterapii Pomorskie Centrum Onkologii,
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Katedra Onkologii Akademii Medycznej w Lodzi
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Oddzial Chemioterapii Zaklad Opieki Zdrowotnej MSWiA
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Oddzial III
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Wielkopolskie Centrum Chorob
City
Poznan
ZIP/Postal Code
60-659
Country
Poland
Facility Name
Oddzial Gruzlicy I Chorob Pluc I P
City
Prabuty
ZIP/Postal Code
82-550
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
S.C. Oncomed SRL
City
Timisoara
State/Province
Timis County
ZIP/Postal Code
300239
Country
Romania
Facility Name
Institute of Oncology, Department of Medical Oncology II
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Institute of Oncology Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Institute of Oncology, Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Craiova Emergency Clinical County Hospital
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Arkhangelsk Regional Clinical Oncology Center
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Chelyabinsk Regional Oncology Center, Chemotherapy Department
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Clinical Oncology Center, Chemotherapy Department
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Omsk Regional Clinical Oncology Center
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Oncology Center
City
Orenburg
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Stavropol Regional Clinical Oncology Center
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Oncology Center, Hematology Department
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital, Department of Thoracic Surgery
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
City General Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
City Clinical Oncology Center, Thoracic Department
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Stavropol Regional Clinical Oncology Center, Chemotherapy Department
City
Stavropol
ZIP/Postal Code
355047
Country
Russian Federation
Facility Name
Tambov Regional Oncology Center, Chemotherapy Department
City
Tambov
ZIP/Postal Code
390013
Country
Russian Federation
Facility Name
Kazan Oncology Center
City
Tatarstan
ZIP/Postal Code
420111
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Oncology Center
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Clinical Hospital Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Nis, Clinic for Lung Diseases "Knez Selo"
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Institute of Lung Diseases Sremka Kamenica
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Kantonales Spital Sursee-Wolhusen
City
Sursee
ZIP/Postal Code
CH 6210
Country
Switzerland
Facility Name
Cherkasy Regional Oncology Center
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Public Treatment and Prophylaxis Institution: Chernihiv Regional Oncology Center
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
City General Hospital #4
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Regional Oncological Center
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
S.P. Grigoryev Institute of Medical Radiology
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Oncology Institute under the Ukrainian Academy of Medical Sciences
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Crimean Republican Clinical Oncology Center
City
Simferopol
ZIP/Postal Code
95023
Country
Ukraine
Facility Name
Zakarpatsky Regional Oncological Clinical Center
City
Uzhorod
ZIP/Postal Code
88014
Country
Ukraine
Facility Name
Anchor Unit, Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Ninewells Hospital and Medical School Department of Cancer Medicine
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Oncology Research, Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG51PB
Country
United Kingdom
Facility Name
Dorset Cancer Centre, Poole Hospital
City
Poole
ZIP/Postal Code
BH152JB
Country
United Kingdom
Facility Name
Yeovil District Hospital NHS Foundation Trust, Higher Kingston
City
Somerset
ZIP/Postal Code
BA214AT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Study of NOV-002 in Combination With Chemotherapy to Treat Lung Cancer

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