MedPath

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

Phase 3
Completed
Conditions
Non Small Cell Lung Cancer
Interventions
Registration Number
NCT00347412
Lead Sponsor
Cellectar Biosciences, Inc.
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
903
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 & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Group B: Chemotherapy AlonePaclitaxelPaclitaxel and Carboplatin
Group A: NOV-002 plus ChemotherapyNOV-002NOV-002 in combination with Paclitaxel and Carboplatin
Group A: NOV-002 plus ChemotherapyPaclitaxelNOV-002 in combination with Paclitaxel and Carboplatin
Group A: NOV-002 plus ChemotherapyCarboplatinNOV-002 in combination with Paclitaxel and Carboplatin
Group B: Chemotherapy AloneCarboplatinPaclitaxel and Carboplatin
Primary Outcome Measures
NameTimeMethod
Overall survival during the length of the trial, length of the trial is approximately two years after last patient in16 months
Secondary Outcome Measures
NameTimeMethod
Improved progression-free survival (PFS)16 months
Immunomodulation as evidenced by changes in lymphocyte subsets16 months
Less myelosuppression and improved recovery from chemotherapy-induced myelosuppression16 months
Higher anti-tumor overall response rate (ORR)16 months

Trial Locations

Locations (75)

Oddzial Chemioterapii Zaklad Opieki Zdrowotnej MSWiA

🇵🇱

Olsztyn, Poland

Oddzial Gruzlicy I Chorob Pluc I P

🇵🇱

Prabuty, Poland

Institute of Oncology, Department of Medical Oncology II

🇷🇴

Bucharest, Romania

Kantonales Spital Sursee-Wolhusen

🇨🇭

Sursee, Switzerland

Crimean Republican Clinical Oncology Center

🇺🇦

Simferopol, Ukraine

City General Hospital #4

🇺🇦

Dnipropetrovsk, Ukraine

Oncology Institute under the Ukrainian Academy of Medical Sciences

🇺🇦

Kyiv, Ukraine

Katedra Onkologii Akademii Medycznej w Lodzi

🇵🇱

Lodz, Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

🇵🇱

Warszawa, Poland

Dorset Cancer Centre, Poole Hospital

🇬🇧

Poole, United Kingdom

Northwest Alabama Cancer Center

🇺🇸

Muscle Shoals, Alabama, United States

Sharp Memorial Hospital

🇺🇸

San Diego, California, United States

Thomas Jefferson University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

William Osler Health Center

🇨🇦

Brampton, Ontario, Canada

University of Chicago Medical Center

🇺🇸

Chicago, Illinois, United States

Northern Indiana Cancer Research Consortium

🇺🇸

South Bend, Indiana, United States

St. Agnes Hospital

🇺🇸

Baltimore, Maryland, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

University of Minnesota Medical Center, Fairview

🇺🇸

Minneapolis, Minnesota, United States

Park Nicollet Clinic - Cancer Center St. Louis Park

🇺🇸

Saint Louis Park, Minnesota, United States

Cleveland Clinic Foundation Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

South Texas Institute of Cancer

🇺🇸

Corpus Christi, Texas, United States

Humber River Regional Hospital

🇨🇦

Weston, Ontario, Canada

Laval Hospital

🇨🇦

Sainte-Foy, Quebec, Canada

Sheba Medical Center

🇮🇱

Ramat Gan, Israel

Jewish General Hospital

🇨🇦

Montreal, Quebec, Canada

Barzilai Medical Center

🇮🇱

Ashkelon, Israel

Lin Clinic

🇮🇱

Haifa, Israel

Meir Medical Center

🇮🇱

Kfar-Saba, Israel

Institute of Oncology

🇮🇱

Petach Tikva, Israel

Azienda Ospedaliera Treviglio Caravaggio

🇮🇹

Bergamo, Italy

Assaf Harofeh Hospital

🇮🇱

Zerifin, Israel

Sondrio Hospital

🇮🇹

Sondrio, Italy

Azienda Ospedaliera Careggi

🇮🇹

Firenze, Italy

Oddzial Pulmonologiczny z Pododdzialem Chemioterapii

🇵🇱

Bystra, Poland

Samodzielny Publiczny Szpital Kliniczny N°.1

🇵🇱

Gdansk, Poland

Oddzial Chemioterapii Pomorskie Centrum Onkologii,

🇵🇱

Gdynia, Poland

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Oddzial III

🇵🇱

Otwock, Poland

Wielkopolskie Centrum Chorob

🇵🇱

Poznan, Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie

🇵🇱

Warsaw, Poland

Institute of Oncology Cluj-Napoca

🇷🇴

Cluj-Napoca, Romania

Institute of Oncology, Cluj-Napoca

🇷🇴

Cluj-Napoca, Romania

S.C. Oncomed SRL

🇷🇴

Timisoara, Timis County, Romania

Craiova Emergency Clinical County Hospital

🇷🇴

Craiova, Romania

Arkhangelsk Regional Clinical Oncology Center

🇷🇺

Arkhangelsk, Russian Federation

Chelyabinsk Regional Oncology Center, Chemotherapy Department

🇷🇺

Chelyabinsk, Russian Federation

Oncology Center, Hematology Department

🇷🇺

Sochi, 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

Leningrad Regional Clinical Hospital, Department of Thoracic Surgery

🇷🇺

St. Petersburg, Russian Federation

Stavropol Regional Clinical Oncology Center, Chemotherapy Department

🇷🇺

Stavropol, Russian Federation

St. Petersburg Pavlov State Medical University under the Federal Agency for Healthcare and Social Development

🇷🇺

St. Petersburg, Russian Federation

City General Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery

🇷🇺

St. Petersburg, Russian Federation

City Clinical Oncology Center, Thoracic Department

🇷🇺

St. Petersburg, Russian Federation

Tambov Regional Oncology Center, Chemotherapy Department

🇷🇺

Tambov, Russian Federation

Clinical Hospital Center Bezanijska kosa

🇷🇸

Belgrade, Serbia

Kazan Oncology Center

🇷🇺

Tatarstan, Russian Federation

Voronezh Regional Clinical Oncology Center

🇷🇺

Voronezh, Russian Federation

Hospital Mutua de Terrassa

🇪🇸

Terrassa, Spain

Clinical Center Nis, Clinic for Lung Diseases "Knez Selo"

🇷🇸

Nis, Serbia

Institute of Lung Diseases Sremka Kamenica

🇷🇸

Sremska Kamenica, Serbia

Hospital Clinic i Provincial de Barcelona

🇪🇸

Barcelona, Spain

Cherkasy Regional Oncology Center

🇺🇦

Cherkassy, Ukraine

Public Treatment and Prophylaxis Institution: Chernihiv Regional Oncology Center

🇺🇦

Chernihiv, Ukraine

Regional Oncological Center

🇺🇦

Ivano-Frankivsk, Ukraine

S.P. Grigoryev Institute of Medical Radiology

🇺🇦

Kharkiv, Ukraine

Anchor Unit, Aberdeen Royal Infirmary

🇬🇧

Aberdeen, Scotland, United Kingdom

Zakarpatsky Regional Oncological Clinical Center

🇺🇦

Uzhorod, Ukraine

St. Luke's Cancer Centre

🇬🇧

Guildford, Surrey, United Kingdom

Oncology Research, Nottingham City Hospital

🇬🇧

Nottingham, United Kingdom

Ninewells Hospital and Medical School Department of Cancer Medicine

🇬🇧

Dundee, Scotland, United Kingdom

Yeovil District Hospital NHS Foundation Trust, Higher Kingston

🇬🇧

Somerset, United Kingdom

Dartmouth Hitchcock Medical Center

🇺🇸

Lebanon, New Hampshire, United States

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