Non Small Cell Lung Cancer Clinical Trial
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)
Verified date | July 2022 |
Source | Cellectar Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 903 |
Est. completion date | February 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | William Osler Health Center | Brampton | Ontario |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | Laval Hospital | Sainte-Foy | Quebec |
Canada | Humber River Regional Hospital | Weston | Ontario |
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Lin Clinic | Haifa | |
Israel | Meir Medical Center | Kfar-Saba | |
Israel | Institute of Oncology | Petach Tikva | |
Israel | Sheba Medical Center | Ramat Gan | |
Israel | Assaf Harofeh Hospital | Zerifin | |
Italy | Azienda Ospedaliera Treviglio Caravaggio | Bergamo | |
Italy | Azienda Ospedaliera Careggi | Firenze | |
Italy | Sondrio Hospital | Sondrio | |
Poland | Oddzial Pulmonologiczny z Pododdzialem Chemioterapii | Bystra | |
Poland | Samodzielny Publiczny Szpital Kliniczny N°.1 | Gdansk | |
Poland | Oddzial Chemioterapii Pomorskie Centrum Onkologii, | Gdynia | |
Poland | Katedra Onkologii Akademii Medycznej w Lodzi | Lodz | |
Poland | Oddzial Chemioterapii Zaklad Opieki Zdrowotnej MSWiA | Olsztyn | |
Poland | Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Oddzial III | Otwock | |
Poland | Wielkopolskie Centrum Chorob | Poznan | |
Poland | Oddzial Gruzlicy I Chorob Pluc I P | Prabuty | |
Poland | Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie | Warsaw | |
Poland | Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie | Warszawa | |
Romania | Institute of Oncology, Department of Medical Oncology II | Bucharest | |
Romania | Institute of Oncology Cluj-Napoca | Cluj-Napoca | |
Romania | Institute of Oncology, Cluj-Napoca | Cluj-Napoca | |
Romania | Craiova Emergency Clinical County Hospital | Craiova | |
Romania | S.C. Oncomed SRL | Timisoara | Timis County |
Russian Federation | Arkhangelsk Regional Clinical Oncology Center | Arkhangelsk | |
Russian Federation | Chelyabinsk Regional Oncology Center, Chemotherapy Department | Chelyabinsk | |
Russian Federation | Clinical Oncology Center, Chemotherapy Department | Kazan | |
Russian Federation | Omsk Regional Clinical Oncology Center | Omsk | |
Russian Federation | Orenburg Regional Clinical Oncology Center | Orenburg | |
Russian Federation | Stavropol Regional Clinical Oncology Center | Pyatigorsk | |
Russian Federation | Oncology Center, Hematology Department | Sochi | |
Russian Federation | City Clinical Oncology Center, Thoracic Department | St. Petersburg | |
Russian Federation | City General Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery | St. Petersburg | |
Russian Federation | Leningrad Regional Clinical Hospital, Department of Thoracic Surgery | St. Petersburg | |
Russian Federation | St. Petersburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development | St. Petersburg | |
Russian Federation | Stavropol Regional Clinical Oncology Center, Chemotherapy Department | Stavropol | |
Russian Federation | Tambov Regional Oncology Center, Chemotherapy Department | Tambov | |
Russian Federation | Kazan Oncology Center | Tatarstan | |
Russian Federation | Voronezh Regional Clinical Oncology Center | Voronezh | |
Serbia | Clinical Hospital Center Bezanijska kosa | Belgrade | |
Serbia | Clinical Center Nis, Clinic for Lung Diseases "Knez Selo" | Nis | |
Serbia | Institute of Lung Diseases Sremka Kamenica | Sremska Kamenica | |
Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | |
Spain | Hospital Mutua de Terrassa | Terrassa | |
Switzerland | Kantonales Spital Sursee-Wolhusen | Sursee | |
Ukraine | Cherkasy Regional Oncology Center | Cherkassy | |
Ukraine | Public Treatment and Prophylaxis Institution: Chernihiv Regional Oncology Center | Chernihiv | |
Ukraine | City General Hospital #4 | Dnipropetrovsk | |
Ukraine | Regional Oncological Center | Ivano-Frankivsk | |
Ukraine | S.P. Grigoryev Institute of Medical Radiology | Kharkiv | |
Ukraine | Oncology Institute under the Ukrainian Academy of Medical Sciences | Kyiv | |
Ukraine | Crimean Republican Clinical Oncology Center | Simferopol | |
Ukraine | Zakarpatsky Regional Oncological Clinical Center | Uzhorod | |
United Kingdom | Anchor Unit, Aberdeen Royal Infirmary | Aberdeen | Scotland |
United Kingdom | Ninewells Hospital and Medical School Department of Cancer Medicine | Dundee | Scotland |
United Kingdom | St. Luke's Cancer Centre | Guildford | Surrey |
United Kingdom | Oncology Research, Nottingham City Hospital | Nottingham | |
United Kingdom | Dorset Cancer Centre, Poole Hospital | Poole | |
United Kingdom | Yeovil District Hospital NHS Foundation Trust, Higher Kingston | Somerset | |
United States | St. Agnes Hospital | Baltimore | Maryland |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | Cleveland Clinic Foundation Taussig Cancer Center | Cleveland | Ohio |
United States | South Texas Institute of Cancer | Corpus Christi | Texas |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota |
United States | Northwest Alabama Cancer Center | Muscle Shoals | Alabama |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | Park Nicollet Clinic - Cancer Center St. Louis Park | Saint Louis Park | Minnesota |
United States | Sharp Memorial Hospital | San Diego | California |
United States | Northern Indiana Cancer Research Consortium | South Bend | Indiana |
Lead Sponsor | Collaborator |
---|---|
Cellectar Biosciences, Inc. |
United States, Canada, Israel, Italy, Poland, Romania, Russian Federation, Serbia, Spain, Switzerland, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival during the length of the trial, length of the trial is approximately two years after last patient in | 16 months | ||
Secondary | Improved progression-free survival (PFS) | 16 months | ||
Secondary | Higher anti-tumor overall response rate (ORR) | 16 months | ||
Secondary | Less myelosuppression and improved recovery from chemotherapy-induced myelosuppression | 16 months | ||
Secondary | Immunomodulation as evidenced by changes in lymphocyte subsets | 16 months |
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