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NGR-hTNF in Combination With Standard Chemotherapy to Treat Patients With Advanced Non-small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994097
First Posted: October 14, 2009
Last Update Posted: October 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MolMed S.p.A.
  Purpose
The main objective of this study is to demonstrate superiority in progression-free survival (PFS) when NGR-hTNF is added to standard chemotherapy regimen (cisplatin/gemcitabine or cisplatin/pemetrexed) in locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-small cell lung cancer (NSCLC).

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: NGR-hTNF Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NGR014: Randomized Phase II Study of NGR-hTNF in Combination With Standard Chemotherapy Versus Standard Chemotherapy Alone in Previously Untreated Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer
MedlinePlus related topics: Lung Cancer
Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium
U.S. FDA Resources

Further study details as provided by MolMed S.p.A.:

Primary Outcome Measures:
  • Progression-free survival (PFS) defined as time from the randomization until to objective disease progression or death due any cause. [ Time Frame: from the randomization until to objective disease progression or death ]

Secondary Outcome Measures:
  • Safety profile of NGR-hTNF in combination with standard chemotherapy as compared to standard chemotherapy alone. [ Time Frame: after initiation of trial treatment until to 28 days after the last treatment administration ]
  • Response rate defined as the percentage of subjects achieving at a specific % tumor volume reduction in according to RECIST criteria. [ Time Frame: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD ]
  • Duration of response (DR) defined as the time that measurement criteria are met for complete response or partial response (whichever status is recorded first) until the progressive disease is objectively documented. [ Time Frame: from the time of first recorded evidence of complete response or partial response until the progressive disease objectively documented ]
  • Overall survival (OS) defined as the time from the randomization until to the date of patient death from any case or discontinuation from the study. [ Time Frame: from the randomization until to the date of patient death or discontinuation from the study ]
Estimated Enrollment: 102
Study Start Date: July 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexed
NGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology
 Drug: NGR-hTNF
NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs
Drug: Cisplatin
Cisplatin: 80 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles
Drug: Gemcitabine
Gemcitabine: 1,250 mg/m2 intravenous infusion on days 1 and 8 every 3 weeks for a maximum of 6 cycles
Drug: Pemetrexed
Pemetrexed: 500 mg/m2 intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles
Active Comparator: B: cisplatin/gemcitabine or cisplatin/pemetrexed
Cisplatin/gemcitabine regimen is administered in patients with squamous histology and cisplatin/pemetrexed regimen is administered in patients with nonsquamous histology
 Drug: Cisplatin
Cisplatin: 80 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles
Drug: Gemcitabine
Gemcitabine: 1,250 mg/m2 intravenous infusion on days 1 and 8 every 3 weeks for a maximum of 6 cycles
Drug: Pemetrexed
Pemetrexed: 500 mg/m2 intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles

Detailed Description:
Eligible patients will be randomly assigned to a standard chemotherapy regimen plus low-dose (0.8 mcg/m^2) NGR-hTNF or standard chemotherapy alone, through a centralized randomization process using the following stratification factors: performance status (0 vs 1) and histology (squamous vs non-squamous). In both arms the choice between the two chemotherapy regimens will be based on the histologic subtype: in patients with squamous histology (including also generic diagnosis of NSCLC without further subtype classification) is recommended cisplatin/gemcitabine regimen, in patients with nonsquamous histology (including adenocarcinoma and large-cell carcinoma) is recommended cisplatin/pemetrexed regimen.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Histologically or cytologically documented inoperable, locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent NSCLC. Mixed tumors should be categorized according to the predominant cell type.
  2. Age ≥18 years
  3. Life expectancy more than 3 months
  4. ECOG performance status 0-1
  5. At least one unidimensional measurable lesion (as per RECIST criteria)

  6. Adequate baseline bone marrow, hepatic and renal function, defined as follows:

    • Neutrophils >1.5 x 10^9/L and platelets > 100 x 10^9/L
    • Bilirubin <1.5 x ULN
    • AST and/or ALT <2.5 x ULN in absence of liver metastasis
    • AST and/or ALT <5 x ULN in presence of liver metastasis
    • Serum creatinine <1.5 x ULN
    • Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min

  7. Patients may have had prior therapy providing the following conditions are met:

    • Radiation therapy: wash-out period of 28 days
    • Surgery: wash-out period of 14 days
  8. Patients must give written informed consent to participate in the study

Exclusion criteria:

  1. Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor).
  2. Patients must not receive any other investigational agents while on study
  3. Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
  4. Uncontrolled hypertension
  5. Prolonged QTc interval (congenital or acquired)
  6. Patient with significant peripheral vascular disease
  7. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke).
  8. Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
  9. Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
  10. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
  11. Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994097


Locations
Italy
Istituto Nazionale per la ricerca sul cancro
Genoa, Italy, 16132
Fondazione San Raffaele del Monte Tabor
Milan, Italy, 20132
Istituto Nazionale dei Tumori
Milan, Italy, 20133
Istituto Europeo Oncologico
Milan, Italy
Sponsors and Collaborators
MolMed S.p.A.
Investigators
Study Director: Antonio Lambiase, MD MolMed S.p.A.
  More Information

Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT00994097     History of Changes
Other Study ID Numbers: NGR014
2008-002703-20 ( EudraCT Number )
First Submitted: October 13, 2009
First Posted: October 14, 2009
Last Update Posted: October 9, 2015
Last Verified: October 2015

Keywords provided by MolMed S.p.A.:
NGR-hTNF
Randomized controlled trial
Gemcitabine
 Cisplatin
Pemetrexed
Carcinoma, non-small cell lung

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Pemetrexed
 Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors


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