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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)

Phase 3
18 Years
Not Enrolling
Non Small Cell Lung Cancer

Thank you

Trial Information

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)

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

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

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

- Pregnant female or nursing mother

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

16 months

Safety Issue:


Principal Investigator

Thomas Lynch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

February 2010

Related Keywords:

  • Non Small Cell Lung Cancer
  • Stage IIIb
  • Stage IV
  • Non Small Cell Lung Cancer (NSCLC)
  • NSCLC Stage IIIb with malignant pleural/pericardial effusion
  • NSCLC Stage IV
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Massachusetts General HospitalBoston, Massachusetts  02114-2617
Sharp Memorial HospitalSan Diego, California  92123
University of Chicago Medical CenterChicago, Illinois  60637
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
St. Agnes HospitalBaltimore, Maryland  21229
University of Minnesota Medical Center, FairviewMinneapolis, Minnesota  55455
Park Nicollet Clinic - Cancer Center St. Louis ParkSt. Louis Park, Minnesota  55416
Cleveland Clinic Foundation Taussig Cancer CenterCleveland, Ohio  44195
South Texas Institute of CancerCorpus Christi, Texas  78405