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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2017-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

NGR-hTNF

Intervention Type DRUG

NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every 3 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs

Cisplatin

Intervention Type DRUG

Cisplatin: 80 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles

Gemcitabine

Intervention Type DRUG

Gemcitabine: 1,250 mg/m² intravenous infusion on days 1 and 8 every 3 weeks for a maximum of 6 cycles

Pemetrexed

Intervention Type DRUG

Pemetrexed: 500 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles

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

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Cisplatin: 80 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles

Gemcitabine

Intervention Type DRUG

Gemcitabine: 1,250 mg/m² intravenous infusion on days 1 and 8 every 3 weeks for a maximum of 6 cycles

Pemetrexed

Intervention Type DRUG

Pemetrexed: 500 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles

Interventions

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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

Intervention Type DRUG

Cisplatin

Cisplatin: 80 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles

Intervention Type DRUG

Gemcitabine

Gemcitabine: 1,250 mg/m² intravenous infusion on days 1 and 8 every 3 weeks for a maximum of 6 cycles

Intervention Type DRUG

Pemetrexed

Pemetrexed: 500 mg/m² intravenous infusion on day 1 every 3 weeks for a maximum of 6 cycles

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No