AzTrials
AzTrials

Non-small Cell Lung CancerPhase 2NCT00994097

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

A Phase 2 study testing NGR-hTNF, Cisplatin and Gemcitabine in people with Non-small Cell Lung Cancer, run by AGC Biologics S.p.A. at 4 sites in Italy.

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 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… 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?
NGR-hTNF, Cisplatin and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
4 sitesItaly
Study dates
Jul 2009to Mar 2017
Phase
Phase 2
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

  • 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)
  • Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Show all 16Show fewer
  • 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
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Istituto Nazionale per la ricerca sul cancro

    Genoa, 16132

  • Fondazione San Raffaele del Monte Tabor

    Milan, 20132

  • Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Europeo Oncologico

    Milan

Other trials in Italy

About this study

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)

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).

Read the 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.

Being tested
NGR-hTNF, Cisplatin, Gemcitabine, Pemetrexed
Keywords
NGR-hTNF, Randomized controlled trial, Gemcitabine, Cisplatin, Pemetrexed, Carcinoma, non-small cell lung
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • NGR-hTNFDrug

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

  • CisplatinDrug

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

  • GemcitabineDrug

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

  • PemetrexedDrug

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

Study groups in NCT00994097
Study groupRoleWhat they receive
A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexedExperimentalNGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology
Receives: Drug: NGR-hTNF; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed
B: cisplatin/gemcitabine or cisplatin/pemetrexedActive comparatorCisplatin/gemcitabine regimen is administered in patients with squamous histology and cisplatin/pemetrexed regimen is administered in patients with nonsquamous histology
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed

What is being measured

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

  1. Progression-free survival (PFS)

    PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)

    Measured: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD

Secondary outcomes (4)

  1. Safety according to NCI-CTCAE criteria (version 3)

    To evaluate safety profile related to NGR-hTNF in combination with standard chemotherapy

    Measured: from the date of randomization until 28 days after last treatment

  2. Objective response rate

    Antitumor activity defined as response rate evaluated according to Response evaluation criteria in solid tumors (RECIST)

    Measured: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD

  3. 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.

    Measured: from the time of first recorded evidence of complete response or partial response until the progressive disease objectively documented

  4. Overall survival (OS)

    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

    Measured: from the randomization until to the date of patient death or discontinuation from the study

Timeline

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

  1. First posted14 Oct 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionMar 2017
  4. Study completionMar 2017

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00994097
Sponsor's protocol ID
NGR014
Other IDs
2008-002703-20, 2008
Status last verified
Aug 2018
First submitted
13 Oct 2009
Last updated
27 Sep 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NGR-hTNF, Cisplatin and Gemcitabine in people with Non-small Cell Lung Cancer, run by AGC Biologics S.p.A. at 4 sites in Italy.

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 16 inclusion and 11 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 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Progression-free survival (PFS) (time frame: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD). 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 NCT00994097.

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 27 Sep 2018.

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