NGR-hTNF in Combination With Standard Chemotherapy to Treat Patients With Advanced Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00994097 |
Recruitment Status :
Completed
First Posted : October 14, 2009
Last Update Posted : September 27, 2018
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Condition or disease | Intervention/treatment | Phase |
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Non-small Cell Lung Cancer | Drug: NGR-hTNF Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 121 participants |
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) |
Actual Study Start Date : | July 2009 |
Actual Primary Completion Date : | March 2017 |
Actual Study Completion Date : | March 2017 |

Arm | Intervention/treatment |
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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
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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
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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 |
- Progression-free survival (PFS) [ Time Frame: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD ]PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
- Safety according to NCI-CTCAE criteria (version 3) [ Time Frame: from the date of randomization until 28 days after last treatment ]To evaluate safety profile related to NGR-hTNF in combination with standard chemotherapy
- Objective response rate [ Time Frame: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD ]Antitumor activity defined as response rate evaluated according to Response evaluation criteria in solid tumors (RECIST)
- Duration of response (DR) [ Time Frame: from the time of first recorded evidence of complete response or partial response until the progressive disease objectively documented ]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.
- Overall survival (OS) [ Time Frame: from the randomization until to the date of patient death or discontinuation from the study ]Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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.
- Age ≥18 years
- Life expectancy more than 3 months
- ECOG performance status 0-1
- At least one unidimensional measurable lesion (as per RECIST criteria)
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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
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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
- Patients must give written informed consent to participate in the study
Exclusion criteria:
- Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor).
- Patients must not receive any other investigational agents while on study
- 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
- Uncontrolled hypertension
- Prolonged QTc interval (congenital or acquired)
- Patient with significant peripheral vascular disease
- 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).
- Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
- Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
- 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.

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
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 |
Study Director: | Antonio Lambiase, MD | AGC Biologics S.p.A. |
Responsible Party: | AGC Biologics S.p.A. |
ClinicalTrials.gov Identifier: | NCT00994097 |
Other Study ID Numbers: |
NGR014 2008-002703-20 ( EudraCT Number ) |
First Posted: | October 14, 2009 Key Record Dates |
Last Update Posted: | September 27, 2018 |
Last Verified: | August 2018 |
NGR-hTNF Randomized controlled trial Gemcitabine |
Cisplatin Pemetrexed Carcinoma, non-small cell lung |
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 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 |