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

NCT00347412 | Completed Phase 3 DMC

• 1 other identifier: NOV002-C301
• Study Type: interventional
• Target: 903
• Locations: 12 countries
• Sites: 75

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  16 months

Secondary Outcomes (4)

• Improved progression-free survival (PFS)

  16 months

• Higher anti-tumor overall response rate (ORR)

  16 months

• Less myelosuppression and improved recovery from chemotherapy-induced myelosuppression

  16 months

• Immunomodulation as evidenced by changes in lymphocyte subsets

  16 months

Study Arms (2)

Group A: NOV-002 plus Chemotherapy

EXPERIMENTAL

NOV-002 in combination with Paclitaxel and Carboplatin

Drug: Paclitaxel; Drug: NOV-002; Drug: Carboplatin

Group B: Chemotherapy Alone

ACTIVE COMPARATOR

Paclitaxel and Carboplatin

Drug: Paclitaxel; Drug: Carboplatin

Interventions

Paclitaxel DRUG

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.

Also known as: Abraxane, Onxol, Taxol

Group A: NOV-002 plus Chemotherapy; Group B: Chemotherapy Alone

NOV-002 DRUG

* 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.

Group A: NOV-002 plus Chemotherapy

Carboplatin DRUG

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.

Also known as: Paraplatin

Group A: NOV-002 plus Chemotherapy; Group B: Chemotherapy Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cellectar Biosciences, Inc.: lead

Study Sites (75)

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, 35661, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

St. Agnes Hospital

Baltimore, Maryland, 21229, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Location

Park Nicollet Clinic - Cancer Center St. Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cleveland Clinic Foundation Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

South Texas Institute of Cancer

Corpus Christi, Texas, 78405, United States

Location

William Osler Health Center

Brampton, Ontario, L6W 2Z8, Canada

Location

Humber River Regional Hospital

Weston, Ontario, M9N 1N8, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Laval Hospital

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Barzilai Medical Center

Ashkelon, 78306, Israel

Location

Lin Clinic

Haifa, 31096, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Institute of Oncology

Petah Tikva, 49100, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Assaf Harofeh Hospital

Ẕerifin, 70300, Israel

Location

Azienda Ospedaliera Treviglio Caravaggio

Bergamo, 24100, Italy

Location

Azienda Ospedaliera Careggi

Florence, 50139, Italy

Location

Sondrio Hospital

Sondrio, 23100, Italy

Location

Oddzial Pulmonologiczny z Pododdzialem Chemioterapii

Bystra, 43-360, Poland

Location

Samodzielny Publiczny Szpital Kliniczny N°.1

Gdansk, 80-952, Poland

Location

Oddzial Chemioterapii Pomorskie Centrum Onkologii,

Gdynia, 81-519, Poland

Location

Katedra Onkologii Akademii Medycznej w Lodzi

Lodz, 93-513, Poland

Location

Oddzial Chemioterapii Zaklad Opieki Zdrowotnej MSWiA

Olsztyn, 10-228, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Oddzial III

Otwock, 05-400, Poland

Location

Wielkopolskie Centrum Chorob

Poznan, 60-659, Poland

Location

Oddzial Gruzlicy I Chorob Pluc I P

Prabuty, 82-550, Poland

Location

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

Warsaw, 02-781, Poland

Location

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

Warsaw, 02-781, Poland

Location

S.C. Oncomed SRL

Timișoara, Timiș County, 300239, Romania

Location

Institute of Oncology, Department of Medical Oncology II

Bucharest, 022328, Romania

Location

Institute of Oncology Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

Institute of Oncology, Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

Craiova Emergency Clinical County Hospital

Craiova, 200642, Romania

Location

Arkhangelsk Regional Clinical Oncology Center

Arkhangelsk, 163045, Russia

Location

Chelyabinsk Regional Oncology Center, Chemotherapy Department

Chelyabinsk, 454087, Russia

Location

Clinical Oncology Center, Chemotherapy Department

Kazan', 420029, Russia

Location

Omsk Regional Clinical Oncology Center

Omsk, 644013, Russia

Location

Orenburg Regional Clinical Oncology Center

Orenburg, 460021, Russia

Location

Stavropol Regional Clinical Oncology Center

Pyatigorsk, 357500, Russia

Location

Leningrad Regional Clinical Hospital, Department of Thoracic Surgery

Saint Petersburg, 194291, Russia

Location

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

Saint Petersburg, 194354, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

City Clinical Oncology Center, Thoracic Department

Saint Petersburg, 198255, Russia

Location

Oncology Center, Hematology Department

Sochi, 354057, Russia

Location

Stavropol Regional Clinical Oncology Center, Chemotherapy Department

Stavropol, 355047, Russia

Location

Tambov Regional Oncology Center, Chemotherapy Department

Tambov, 390013, Russia

Location

Kazan Oncology Center

Tatarstan, 420111, Russia

Location

Voronezh Regional Clinical Oncology Center

Voronezh, 394000, Russia

Location

Clinical Hospital Center Bezanijska kosa

Belgrade, 11080, Serbia

Location

Institute of Lung Diseases Sremka Kamenica

Kamenitz, 21204, Serbia

Location

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

Niš, 18000, Serbia

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Mutua de Terrassa

Terrassa, 08221, Spain

Location

Kantonales Spital Sursee-Wolhusen

Sursee, CH 6210, Switzerland

Location

Cherkasy Regional Oncology Center

Cherkassy, 18009, Ukraine

Location

Public Treatment and Prophylaxis Institution: Chernihiv Regional Oncology Center

Chernihiv, 14029, Ukraine

Location

City General Hospital #4

Dnipropetrovsk, 49102, Ukraine

Location

Regional Oncological Center

Ivano-Frankivsk, 76014, Ukraine

Location

S.P. Grigoryev Institute of Medical Radiology

Kharkiv, 61024, Ukraine

Location

Oncology Institute under the Ukrainian Academy of Medical Sciences

Kyiv, 03022, Ukraine

Location

Crimean Republican Clinical Oncology Center

Simferopol, 95023, Ukraine

Location

Zakarpatsky Regional Oncological Clinical Center

Uzhhorod, 88014, Ukraine

Location

Anchor Unit, Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital and Medical School Department of Cancer Medicine

Dundee, Scotland, DD1 9SY, United Kingdom

Location

St. Luke's Cancer Centre

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Oncology Research, Nottingham City Hospital

Nottingham, NG51PB, United Kingdom

Location

Dorset Cancer Centre, Poole Hospital

Poole, BH152JB, United Kingdom

Location

Yeovil District Hospital NHS Foundation Trust, Higher Kingston

Somerset, BA214AT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pericardial Effusion

Interventions

Paclitaxel; Albumin-Bound Paclitaxel; NOV 002; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Coordination Complexes

Study Officials

• Thomas Lynch, MD

  Massachusetts General Hospital

  STUDY CHAIR

• Panos Fidias, MD

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: July 4, 2006
• Study Start: November 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

IL (6); SE (3); PL (10); ES (2); US (12); CA (4); UA (8); CH (1); GB (6); RU (15); RO (5); IT (3)