Small Cell Lung CancerPhase 2NGR007NCT00483509
Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma
A Phase 2 study testing NGR-hTNF and Doxorubicin in people with Small Cell Lung Cancer, run by AGC Biologics S.p.A. at 5 sites in Italy.
Trial summary
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic small cell lung carcinoma (SCLC) patients previously treated with at least one therapeutic regimen Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- NGR-hTNF and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesItaly
- Study dates
- 14 Feb 2007to 17 May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients ≥ 18 years affected by SCLC previously treated with at least one therapeutic regimen (including doxorubicin). However, in case of patient already pretreated with doxorubicin, a previous cumulative dose of doxorubicin < 300 mg/m^2 is recommended and the current treatment has to be stopped when a maximum cumulative dose of doxorubicin 550 mg/m^2 is reached.
- Cytology or histology confirmed SCLC at first diagnosis (patient with recurrent disease do not require a confirmatory biopsy to be eligible)
- Measurable disease, defined as ≥ 1 unidimensional measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by CT scan according to RECIST criteria
- ECOG Performance status 0 - 2
- 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
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- 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
- Normal cardiac function (LVEF ≥ 55%) and absence of uncontrolled hypertension
- Patients may have had prior therapy providing the following conditions are met:
- Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days before start treatment
- Surgery: wash-out period of 14 days before start treatment
- Patients must give written informed consent to participate in the study
Who cannot join
- Concurrent anticancer therapy
- Patients may 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
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- Previous signs of cardiotoxicity doxorubicin related
- Clinical signs of CNS involvement
- 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
- Known hypersensitivity/allergic reaction or contraindications to anthracyclines
- 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 childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Azienda Ospedaliera Universitaria San Martino
Genoa, 16132
Istituto Nazionale per la Ricerca sul Cancro
Genoa, 16132
Fondazione San Raffaele del Monte Tabor
Milan, 20132
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Turin, 10043
Istituto Clinico Humanitas
Rozzano, Milan, 20089
About this study
Official title: NGR007: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Small Cell Lung Carcinoma (SCLC) Previously Treated With at Least One Therapeutic Regimen
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic small cell lung carcinoma (SCLC) patients previously treated with at least one therapeutic regimen
Read the detailed description
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at least one therapeutic regimen, that will be conducted using Simon's two-stage design method.
- Conditions
- Small Cell Lung Cancer
- Being tested
- NGR-hTNF, Doxorubicin
- Keywords
- NGR-hTNF, SCLC
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGR-hTNFDrug
iv q3W 0.8 mcg/sqm NGR-hTNF
DoxorubicinDrug
iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion
| Study group | Role | What they receive |
|---|---|---|
| A: NGR-hTNF + doxorubicin | Experimental | NGR-hTNF plus doxorubicin Receives: Drug: NGR-hTNF; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumour Activity Defined as Progression Free Survival (PFS)
Defined as the time from the date of randomization until disease progression, or death due to any cause or the last patient was known to be alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition the appearance of one or more new lesions was also considered progression
Measured: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 150 weeks
Secondary outcomes (4)
Tumor Growth Control Rate (TGCR)
evaluated according to Response evaluation criteria in solid tumors (RECIST V1.0) for target lesions and assessed by MRI:
- Complete Response (CR):Disappearance of all target lesions
- Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the base line sum LD
- Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Measured: Assessed every 6-12 weeks, up to 150 weeks
Overall Survival (OS)
Overall Survival was defined as the time from the baseline CT scan to death due to any cause, or the last date the patient was known to be alive.
Measured: Through study completion, an average of 3 years
Experimental Imaging Study (DCE-MRI)
To document possible modifications on vessels permeability by imaging techniques
Measured: during the study
Number of Adverse Events, Reported by Severity and Relation to Treatment
Evaluation according to NCI common terminology criteria for adverse events (version 3.0)
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study start14 Feb 2007
- Primary completion22 Sep 2010
- Study completion17 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGC Biologics S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Lambiase, MD, Study director, AGC Biologics S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483509
- Sponsor's protocol ID
- NGR007
- Other IDs
- 2006-005700-14
- Acronym
- NGR007
- Status last verified
- Sep 2019
- First submitted
- 6 Jun 2007
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gregorc V, Cavina R, Novello S, Grossi F, Lazzari C, Capelletto E, Genova C, Salini G, Lambiase A, Santoro A. NGR-hTNF and Doxorubicin as Second-Line Treatment of Patients with Small Cell Lung Cancer. Oncologist. 2018 Oct;23(10):1133-e112. doi: 10.1634/theoncologist.2018-0292. Epub 2018 Aug 3.
PubMed 30076277
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NGR007: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Small Cell Lung Carcinoma (SCLC) Previously Treated With at Least One Therapeutic Regimen
- ClinicalTrials.gov ID
- NCT00483509
- Acronym / sponsor ID
- NGR007 / NGR007
- Conditions
- Small Cell Lung Cancer
- Keywords
- NGR-hTNF, SCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AGC Biologics S.p.A.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2007 (actual)
- Primary completion
- 22 Sep 2010 (actual)
- Study completion
- 17 May 2011 (actual)
- First posted
- 7 Jun 2007 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic small cell lung carcinoma (SCLC) patients previously treated with at least one therapeutic regimen
Detailed description
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at least one therapeutic regimen, that will be conducted using Simon's two-stage design method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A: NGR-hTNF + doxorubicin | Experimental | Drug: NGR-hTNF, Drug: DoxorubicinNGR-hTNF plus doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients ≥ 18 years affected by SCLC previously treated with at least one therapeutic regimen (including doxorubicin). However, in case of patient already pretreated with doxorubicin, a previous cumulative dose of doxorubicin < 300 mg/m^2 is recommended and the current treatment has to be stopped when a maximum cumulative dose of doxorubicin 550 mg/m^2 is reached.
- Cytology or histology confirmed SCLC at first diagnosis (patient with recurrent disease do not require a confirmatory biopsy to be eligible)
- Measurable disease, defined as ≥ 1 unidimensional measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by CT scan according to RECIST criteria
- ECOG Performance status 0 - 2
- Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Key exclusion criteria (13 listed)
- Concurrent anticancer therapy
- Patients may 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGR-hTNFiv q3W 0.8 mcg/sqm NGR-hTNF | Drug | A: NGR-hTNF + doxorubicin |
| Doxorubiciniv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion | Drug | A: NGR-hTNF + doxorubicin |
Primary outcome
Antitumour Activity Defined as Progression Free Survival (PFS)
Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 150 weeks
Defined as the time from the date of randomization until disease progression, or death due to any cause or the last patient was known to be alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition the appearance of one or more new lesions was also considered progression
4 secondary outcomes
Tumor Growth Control Rate (TGCR)
Time frame: Assessed every 6-12 weeks, up to 150 weeks
Overall Survival (OS)
Time frame: Through study completion, an average of 3 years
Experimental Imaging Study (DCE-MRI)
Time frame: during the study
Number of Adverse Events, Reported by Severity and Relation to Treatment
Time frame: Through study completion, an average of 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30076277Gregorc V, Cavina R, Novello S, Grossi F, Lazzari C, Capelletto E, Genova C, Salini G, Lambiase A, Santoro A. NGR-hTNF and Doxorubicin as Second-Line Treatment of Patients with Small Cell Lung Cancer. Oncologist. 2018 Oct;23(10):1133-e112. doi: 10.1634/theoncologist.2018-0292. Epub 2018 Aug 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Lambiase, MD study director
AGC Biologics S.p.A.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NGR-hTNF and Doxorubicin in people with Small Cell Lung Cancer, run by AGC Biologics S.p.A. at 5 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 15 inclusion and 13 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 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Antitumour Activity Defined as Progression Free Survival (PFS) (time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 150 weeks). 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 NCT00483509, which also lists 1 linked publication.
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 4 Oct 2019.