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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 73 Locations for this study
Muscle Shoals Alabama, 35661, United States
San Diego California, 92123, United States
Chicago Illinois, 60637, United States
South Bend Indiana, 46601, United States
Baltimore Maryland, 21229, United States
Boston Massachusetts, 02144, United States
Minneapolis Minnesota, 55455, United States
Saint Louis Park Minnesota, 55416, United States
Lebanon New Hampshire, 03756, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19107, United States
Corpus Christi Texas, 78405, United States
Brampton Ontario, L6W 2, Canada
Weston Ontario, M9N 1, Canada
Montreal Quebec, H3T1E, Canada
Sainte-Foy Quebec, G1V 4, Canada
Ashkelon , 78306, Israel
Haifa , 31096, Israel
Kfar-Saba , 44281, Israel
Petach Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Zerifin , 70300, Israel
Bergamo , 24100, Italy
Firenze , 50139, Italy
Sondrio , 23100, Italy
Bystra , 43-36, Poland
Gdansk , 80-95, Poland
Gdynia , 81-51, Poland
Lodz , 93-51, Poland
Olsztyn , 10-22, Poland
Otwock , 05-40, Poland
Poznan , 60-65, Poland
Prabuty , 82-55, Poland
Warsaw , 02-78, Poland
Warszawa , 02-78, Poland
Timisoara Timis County, 30023, Romania
Bucharest , 02232, Romania
Cluj-Napoca , 40001, Romania
Cluj-Napoca , 40001, Romania
Craiova , 20064, Romania
Arkhangelsk , 16304, Russian Federation
Chelyabinsk , 45408, Russian Federation
Kazan , 42002, Russian Federation
Omsk , 64401, Russian Federation
Orenburg , 46002, Russian Federation
Pyatigorsk , 35750, Russian Federation
Sochi , 35405, Russian Federation
St. Petersburg , 19429, Russian Federation
St. Petersburg , 19435, Russian Federation
St. Petersburg , 19702, Russian Federation
St. Petersburg , 19825, Russian Federation
Stavropol , 35504, Russian Federation
Tambov , 39001, Russian Federation
Tatarstan , 42011, Russian Federation
Voronezh , 39400, Russian Federation
Belgrade , 11080, Serbia
Nis , 18000, Serbia
Sremska Kamenica , 21204, Serbia
Barcelona , 08036, Spain
Terrassa , 08221, Spain
Sursee , CH 62, Switzerland
Cherkassy , 18009, Ukraine
Chernihiv , 14029, Ukraine
Dnipropetrovsk , 49102, Ukraine
Ivano-Frankivsk , 76014, Ukraine
Kharkiv , 61024, Ukraine
Kyiv , 03022, Ukraine
Simferopol , 95023, Ukraine
Uzhorod , 88014, Ukraine
Aberdeen Scotland, AB25 , United Kingdom
Dundee Scotland, DD1 9, United Kingdom
Guildford Surrey, GU2 7, United Kingdom
Nottingham , NG51P, United Kingdom
Poole , BH152, United Kingdom
Somerset , BA214, United Kingdom
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.