AzTrials
AzTrials

Non Small Cell Lung CancerPhase 3NCT00347412

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

A Phase 3 study testing Paclitaxel, NOV-002 and Carboplatin in people with Non Small Cell Lung Cancer, run by Cellectar Biosciences, Inc. at 75 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Paclitaxel, NOV-002 and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
903 participants
Where
75 sitesin 12 countries
Study dates
Nov 2006to Feb 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

75 sites in 12 countries.

75 sites in 12 countries

Russia15 sites

  • Arkhangelsk Regional Clinical Oncology Center

    Arkhangelsk, 163045

  • Chelyabinsk Regional Oncology Center, Chemotherapy Department

    Chelyabinsk, 454087

  • Clinical Oncology Center, Chemotherapy Department

    Kazan', 420029

  • Omsk Regional Clinical Oncology Center

    Omsk, 644013

  • Orenburg Regional Clinical Oncology Center

    Orenburg, 460021

  • Stavropol Regional Clinical Oncology Center

    Pyatigorsk, 357500

  • Leningrad Regional Clinical Hospital, Department of Thoracic Surgery

    Saint Petersburg, 194291

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

    Saint Petersburg, 194354

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

    Saint Petersburg, 197022

  • City Clinical Oncology Center, Thoracic Department

    Saint Petersburg, 198255

  • Oncology Center, Hematology Department

    Sochi, 354057

  • Stavropol Regional Clinical Oncology Center, Chemotherapy Department

    Stavropol, 355047

  • Tambov Regional Oncology Center, Chemotherapy Department

    Tambov, 390013

  • Kazan Oncology Center

    Tatarstan, 420111

  • Voronezh Regional Clinical Oncology Center

    Voronezh, 394000

Other trials in Russia

United States12 sites

  • St. Agnes Hospital

    Baltimore, Maryland, 21229

  • Massachusetts General Hospital

    Boston, Massachusetts, 02144

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundation Taussig Cancer Center

    Cleveland, Ohio, 44195

  • South Texas Institute of Cancer

    Corpus Christi, Texas, 78405

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota, 55455

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Park Nicollet Clinic - Cancer Center St. Louis Park

    Saint Louis Park, Minnesota, 55416

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

Other trials in United States

Poland10 sites

  • Oddzial Pulmonologiczny z Pododdzialem Chemioterapii

    Bystra, 43-360

  • Samodzielny Publiczny Szpital Kliniczny N°.1

    Gdansk, 80-952

  • Oddzial Chemioterapii Pomorskie Centrum Onkologii,

    Gdynia, 81-519

  • Katedra Onkologii Akademii Medycznej w Lodzi

    Lodz, 93-513

  • Oddzial Chemioterapii Zaklad Opieki Zdrowotnej MSWiA

    Olsztyn, 10-228

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy Oddzial III

    Otwock, 05-400

  • Wielkopolskie Centrum Chorob

    Poznan, 60-659

  • Oddzial Gruzlicy I Chorob Pluc I P

    Prabuty, 82-550

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

    Warsaw, 02-781

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Ukraine8 sites

  • Cherkasy Regional Oncology Center

    Cherkassy, 18009

  • Public Treatment and Prophylaxis Institution: Chernihiv Regional Oncology Center

    Chernihiv, 14029

  • City General Hospital #4

    Dnipropetrovsk, 49102

  • Regional Oncological Center

    Ivano-Frankivsk, 76014

  • S.P. Grigoryev Institute of Medical Radiology

    Kharkiv, 61024

  • Oncology Institute under the Ukrainian Academy of Medical Sciences

    Kyiv, 03022

  • Crimean Republican Clinical Oncology Center

    Simferopol, 95023

  • Zakarpatsky Regional Oncological Clinical Center

    Uzhhorod, 88014

Other trials in Ukraine

Israel6 sites

  • Barzilai Medical Center

    Ashkelon, 78306

  • Lin Clinic

    Haifa, 31096

  • Meir Medical Center

    Kfar Saba, 44281

  • Institute of Oncology

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 52621

  • Assaf Harofeh Hospital

    Tsrifin, 70300

Other trials in Israel

United Kingdom6 sites

  • Anchor Unit, Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Ninewells Hospital and Medical School Department of Cancer Medicine

    Dundee, Scotland, DD1 9SY

  • St. Luke's Cancer Centre

    Guildford, Surrey, GU2 7XX

  • Oncology Research, Nottingham City Hospital

    Nottingham, NG51PB

  • Dorset Cancer Centre, Poole Hospital

    Poole, BH152JB

  • Yeovil District Hospital NHS Foundation Trust, Higher Kingston

    Somerset, BA214AT

Other trials in United Kingdom

Romania5 sites

  • Institute of Oncology, Department of Medical Oncology II

    Bucharest, 022328

  • Institute of Oncology Cluj-Napoca

    Cluj-Napoca, 400015

  • Institute of Oncology, Cluj-Napoca

    Cluj-Napoca, 400015

  • Craiova Emergency Clinical County Hospital

    Craiova, 200642

  • S.C. Oncomed SRL

    Timișoara, Timiș County, 300239

Other trials in Romania

Canada4 sites

  • William Osler Health Center

    Brampton, Ontario, L6W 2Z8

  • Jewish General Hospital

    Montreal, Quebec, H3T1E2

  • Laval Hospital

    Sainte-Foy, Quebec, G1V 4G5

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

Other trials in Canada

Italy3 sites

  • Azienda Ospedaliera Treviglio Caravaggio

    Bergamo, 24100

  • Azienda Ospedaliera Careggi

    Florence, 50139

  • Sondrio Hospital

    Sondrio, 23100

Other trials in Italy

Serbia3 sites

  • Clinical Hospital Center Bezanijska kosa

    Belgrade, 11080

  • Institute of Lung Diseases Sremka Kamenica

    Kamenitz, 21204

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

    Niš, 18000

Other trials in Serbia

Spain2 sites

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Mutua de Terrassa

    Terrassa, 08221

Other trials in Spain

Switzerland1 site

  • Kantonales Spital Sursee-Wolhusen

    Sursee, CH 6210

Other trials in Switzerland

About this study

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)

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.

Read the 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.

Being tested
Paclitaxel, NOV-002, Carboplatin
Keywords
NSCLC, Stage IIIb, Stage IV, Non Small Cell Lung Cancer (NSCLC), NSCLC Stage IIIb with malignant pleural/pericardial effusion, NSCLC Stage IV
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Pericardial Effusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Abraxane, Onxol, Taxol

    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.

  • NOV-002Drug

    • 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.

  • CarboplatinDrug

    Also called Paraplatin

    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.

Study groups in NCT00347412
Study groupRoleWhat they receive
Group A: NOV-002 plus ChemotherapyExperimentalNOV-002 in combination with Paclitaxel and Carboplatin
Receives: Drug: Paclitaxel; Drug: NOV-002; Drug: Carboplatin
Group B: Chemotherapy AloneActive comparatorPaclitaxel and Carboplatin
Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 16 months

Secondary outcomes (4)

  1. Improved progression-free survival (PFS)

    Measured: 16 months

  2. Higher anti-tumor overall response rate (ORR)

    Measured: 16 months

  3. Less myelosuppression and improved recovery from chemotherapy-induced myelosuppression

    Measured: 16 months

  4. Immunomodulation as evidenced by changes in lymphocyte subsets

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJan 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
903 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00347412
Sponsor's protocol ID
NOV002-C301
Status last verified
Jul 2022
First submitted
29 Jun 2006
Last updated
25 Jul 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel, NOV-002 and Carboplatin in people with Non Small Cell Lung Cancer, run by Cellectar Biosciences, Inc. at 75 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Russia, United States, Poland, Ukraine, Israel and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival during the length of the trial, length of the trial is approximately two years after last patient in (time frame: 16 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00347412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in