Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

903

Study ID:

NCT00347412

Recruitment Status:

Completed

Sponsor:

Cellectar Biosciences, Inc.

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There are 73 Locations for this study

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Northwest Alabama Cancer Center
Muscle Shoals Alabama, 35661, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Northern Indiana Cancer Research Consortium
South Bend Indiana, 46601, United States
St. Agnes Hospital
Baltimore Maryland, 21229, United States
Massachusetts General Hospital
Boston Massachusetts, 02144, United States
University of Minnesota Medical Center, Fairview
Minneapolis Minnesota, 55455, United States
Park Nicollet Clinic - Cancer Center St. Louis Park
Saint Louis Park Minnesota, 55416, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Cleveland Clinic Foundation Taussig Cancer Center
Cleveland Ohio, 44195, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
South Texas Institute of Cancer
Corpus Christi Texas, 78405, United States
William Osler Health Center
Brampton Ontario, L6W 2, Canada
Humber River Regional Hospital
Weston Ontario, M9N 1, Canada
Jewish General Hospital
Montreal Quebec, H3T1E, Canada
Laval Hospital
Sainte-Foy Quebec, G1V 4, Canada
Barzilai Medical Center
Ashkelon , 78306, Israel
Lin Clinic
Haifa , 31096, Israel
Meir Medical Center
Kfar-Saba , 44281, Israel
Institute of Oncology
Petach Tikva , 49100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Assaf Harofeh Hospital
Zerifin , 70300, Israel
Azienda Ospedaliera Treviglio Caravaggio
Bergamo , 24100, Italy
Azienda Ospedaliera Careggi
Firenze , 50139, Italy
Sondrio Hospital
Sondrio , 23100, Italy
Oddzial Pulmonologiczny z Pododdzialem Chemioterapii
Bystra , 43-36, Poland
Samodzielny Publiczny Szpital Kliniczny N°.1
Gdansk , 80-95, Poland
Oddzial Chemioterapii Pomorskie Centrum Onkologii,
Gdynia , 81-51, Poland
Katedra Onkologii Akademii Medycznej w Lodzi
Lodz , 93-51, Poland
Oddzial Chemioterapii Zaklad Opieki Zdrowotnej MSWiA
Olsztyn , 10-22, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Oddzial III
Otwock , 05-40, Poland
Wielkopolskie Centrum Chorob
Poznan , 60-65, Poland
Oddzial Gruzlicy I Chorob Pluc I P
Prabuty , 82-55, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
Warsaw , 02-78, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Warszawa , 02-78, Poland
S.C. Oncomed SRL
Timisoara Timis County, 30023, Romania
Institute of Oncology, Department of Medical Oncology II
Bucharest , 02232, Romania
Institute of Oncology Cluj-Napoca
Cluj-Napoca , 40001, Romania
Institute of Oncology, Cluj-Napoca
Cluj-Napoca , 40001, Romania
Craiova Emergency Clinical County Hospital
Craiova , 20064, Romania
Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk , 16304, Russian Federation
Chelyabinsk Regional Oncology Center, Chemotherapy Department
Chelyabinsk , 45408, Russian Federation
Clinical Oncology Center, Chemotherapy Department
Kazan , 42002, Russian Federation
Omsk Regional Clinical Oncology Center
Omsk , 64401, Russian Federation
Orenburg Regional Clinical Oncology Center
Orenburg , 46002, Russian Federation
Stavropol Regional Clinical Oncology Center
Pyatigorsk , 35750, Russian Federation
Oncology Center, Hematology Department
Sochi , 35405, Russian Federation
Leningrad Regional Clinical Hospital, Department of Thoracic Surgery
St. Petersburg , 19429, Russian Federation
City General Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery
St. Petersburg , 19435, Russian Federation
St. Petersburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development
St. Petersburg , 19702, Russian Federation
City Clinical Oncology Center, Thoracic Department
St. Petersburg , 19825, Russian Federation
Stavropol Regional Clinical Oncology Center, Chemotherapy Department
Stavropol , 35504, Russian Federation
Tambov Regional Oncology Center, Chemotherapy Department
Tambov , 39001, Russian Federation
Kazan Oncology Center
Tatarstan , 42011, Russian Federation
Voronezh Regional Clinical Oncology Center
Voronezh , 39400, Russian Federation
Clinical Hospital Center Bezanijska kosa
Belgrade , 11080, Serbia
Clinical Center Nis, Clinic for Lung Diseases "Knez Selo"
Nis , 18000, Serbia
Institute of Lung Diseases Sremka Kamenica
Sremska Kamenica , 21204, Serbia
Hospital Clinic i Provincial de Barcelona
Barcelona , 08036, Spain
Hospital Mutua de Terrassa
Terrassa , 08221, Spain
Kantonales Spital Sursee-Wolhusen
Sursee , CH 62, Switzerland
Cherkasy Regional Oncology Center
Cherkassy , 18009, Ukraine
Public Treatment and Prophylaxis Institution: Chernihiv Regional Oncology Center
Chernihiv , 14029, Ukraine
City General Hospital #4
Dnipropetrovsk , 49102, Ukraine
Regional Oncological Center
Ivano-Frankivsk , 76014, Ukraine
S.P. Grigoryev Institute of Medical Radiology
Kharkiv , 61024, Ukraine
Oncology Institute under the Ukrainian Academy of Medical Sciences
Kyiv , 03022, Ukraine
Crimean Republican Clinical Oncology Center
Simferopol , 95023, Ukraine
Zakarpatsky Regional Oncological Clinical Center
Uzhorod , 88014, Ukraine
Anchor Unit, Aberdeen Royal Infirmary
Aberdeen Scotland, AB25 , United Kingdom
Ninewells Hospital and Medical School Department of Cancer Medicine
Dundee Scotland, DD1 9, United Kingdom
St. Luke's Cancer Centre
Guildford Surrey, GU2 7, United Kingdom
Oncology Research, Nottingham City Hospital
Nottingham , NG51P, United Kingdom
Dorset Cancer Centre, Poole Hospital
Poole , BH152, United Kingdom
Yeovil District Hospital NHS Foundation Trust, Higher Kingston
Somerset , BA214, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

903

Study ID:

NCT00347412

Recruitment Status:

Completed

Sponsor:


Cellectar Biosciences, Inc.

How clear is this clinincal trial information?

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