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NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

Primary Purpose

Malignant Pleural Mesothelioma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NGR-hTNF plus Best Investigator's Choice (BIC)
Placebo plus Best Investigator's Choice (BIC)
Sponsored by
AGC Biologics S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Mesothelioma focused on measuring MPM, NGR-hTNF, NGR-hTNF plus BIC, Randomized double-blind phase III study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
  • Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin
  • ECOG Performance Status 0 - 2
  • Life expectancy of ≥ 12 weeks

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

    1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
    2. Bilirubin ≤ 1.5 x ULN
    3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
    4. Serum creatinine < 1.5 x ULN
  • Measurable or non-measurable disease according to MPM-modified RECIST criteria

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

    1. Surgery: wash-out period of 14 days
    2. Systemic and radiation anti-tumor therapy: wash-out period of 28 days
  • Patients must give written informed consent to participate in the study

Exclusion Criteria:

  • Patients must not receive any other investigational agents while on study
  • Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
  • Uncontrolled hypertension
  • QTc interval (congenital or acquired) > 450 ms
  • 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 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

Sites / Locations

  • Wilshire Oncology Medical Group
  • City of Hope-Comprehensive Cancer Cente
  • H. Lee Moffitt ancer Center and Research Institute
  • Johns Hopkins
  • Columbia University
  • University of Pennsylvania
  • UTsouthwestern medical center
  • Antwerp University Hospital
  • Centre Hospitalier Universitaire de Liège
  • Institut Jules Bordet
  • Cliniques Universitarie St. Luc
  • Universitair Ziekenhuis
  • UAB - Alberta Cancer Board - Cross Cancer Institute
  • University Health Network, Princess Margaret Hospital
  • National Cancer Institute
  • Hôpitaux de Marseille Hôpital Nord
  • St James's Hospital
  • Ospedale Santo Spirito
  • Azienda Ospedaliera Universitaria San Luigi Gonzaga
  • Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
  • Centro di Riferimento Oncologico
  • Ospedale Valduce
  • Azienda Ospedaliero-Universitaria Careggi di Firenze
  • Istituto Nazionale per la Ricerca sul Cancro
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST
  • Fondazione San Raffaele del Monte Tabor
  • Azienda Ospedaliera San Gerardo
  • Istituto Oncologico Veneto
  • Azienda Ospedaliero Universitaria di Parma
  • Azienda Unità Sanitaria locale di Ravenna
  • A.O. Salvini Garbagnate, Ospedale di Rho
  • Azienda Ospedaliera Senese
  • St. Jansdal Hospital
  • St. Antonius Hospital
  • Medical University of Gdansk
  • Maria Sklodowska Memorial Cancer Center and Institute of Oncology
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Vall d'Hebron
  • The University Hospital
  • Chest Clinic, Wythenshawe Hospital
  • Kent Oncology Centre Maidstone Hospital
  • University Hospitals of Leicester
  • Mount Vernon Cancer Centre
  • Edinburgh Cancer Centre, Western General Hospital
  • The Beatson West of Scotland Cancer Centre
  • The Royal Marsden Hospital
  • Castle Hill Hospital
  • Guy's Hospital
  • The Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A: NGR-hTNF + BIC

B: Placebo+BIC

Arm Description

NGR-hTNF plus Best Investigator's Choice

Placebo plus Best Investigator's Choice

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression-Free Survival (PFS)
Defined as the time from the date of randomization until disease progression, or deathdue to any couse or the last patient was konwn to be alive. Progression is defined usind 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 torelative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm. In addition the appearance of one or more new lesions was also considered progression
Disease Control Rate (DCR)
Disease control rate (DCR), defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Number of Partecipants With Disease Control for ≥ 6 Months
Measured from the date of randomization until disease progression, or death due to any cause
Number of Partecipants With Adverse Events
All adverse events will be recorded according to CTC version 4.02 (CTC reference: http://ctep.cancer.gov/reporting/ctc.html) on the case report forms (CRFs); the investigator will decide if those events are drug related and his decision will be recorded on the forms for all adverse events.
Time to LCSS Symptomatic Progression
Quality of life (QoL) assessment was performed by using a questionnaire according to The Lung Cancer Symptom Scale (LCSS) . The LCSS is designed as a disease and site-specific measure of QoL particularly for use in clinical trials. It evaluates six major symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global QoL. Within this trial the questionnaire according to LCSS was only recorded by the patient (patient's scale). QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100 (0 representing the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all six major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.
Evaluation of Medical Care Utilization in the Two Treatment Arms
Medical resource use data collected will be used in health economic analyses where it may be combined with other data from other sources such as cost data or other clinical parameters.

Full Information

First Posted
March 17, 2010
Last Updated
August 28, 2019
Sponsor
AGC Biologics S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01098266
Brief Title
NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
Official Title
NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 12, 2010 (Actual)
Primary Completion Date
April 29, 2014 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGC Biologics S.p.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
Detailed Description
Currently, there are no regulatory-approved or widely accepted treatment options for patients failing a standard pemetrexed-based chemotherapy regimen. For this reason, the best supportive care (BSC) alone might be considered as a standard reference for a randomized phase III trial in this setting. However, single-agent chemotherapeutic agents (such as doxorubicin,gemcitabine, or vinorelbine) with a well-documented safety profile and antitumor activity are also used in clinical practice. Therefore, the best investigator's choice (BIC) between either best supportive care alone or combined with a few selected single-agent chemotherapy (including doxorubicin, gemcitabine, or vinorelbine) might be considered as an acceptable reference arm as well in this setting. The current phase III study aims to show a superior efficacy in terms of overall survival duration of NGR-hTNF 0.8 µg/mq weekly plus BIC versus placebo plus BIC in advanced MPM patients progressing after a standard pemetrexed-based chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma
Keywords
MPM, NGR-hTNF, NGR-hTNF plus BIC, Randomized double-blind phase III study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: NGR-hTNF + BIC
Arm Type
Experimental
Arm Description
NGR-hTNF plus Best Investigator's Choice
Arm Title
B: Placebo+BIC
Arm Type
Placebo Comparator
Arm Description
Placebo plus Best Investigator's Choice
Intervention Type
Drug
Intervention Name(s)
NGR-hTNF plus Best Investigator's Choice (BIC)
Other Intervention Name(s)
NGR-hTNF+BIC
Intervention Description
NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
Intervention Type
Drug
Intervention Name(s)
Placebo plus Best Investigator's Choice (BIC)
Other Intervention Name(s)
Placebo+BIC
Intervention Description
Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Defined as the time from the date of randomization until disease progression, or deathdue to any couse or the last patient was konwn to be alive. Progression is defined usind 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 torelative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm. In addition the appearance of one or more new lesions was also considered progression
Time Frame
From the date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assessed up to 48 months
Title
Disease Control Rate (DCR)
Description
Disease control rate (DCR), defined as the percentage of patients who have a best-response rating of complete or partial response or stable disease, according to MPM-modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time Frame
Assessed every 6-12 weeks, up to 100 weeks
Title
Number of Partecipants With Disease Control for ≥ 6 Months
Description
Measured from the date of randomization until disease progression, or death due to any cause
Time Frame
Assessed every 6-12 weeks, up to 100 weeks
Title
Number of Partecipants With Adverse Events
Description
All adverse events will be recorded according to CTC version 4.02 (CTC reference: http://ctep.cancer.gov/reporting/ctc.html) on the case report forms (CRFs); the investigator will decide if those events are drug related and his decision will be recorded on the forms for all adverse events.
Time Frame
Assessed every 6-12 weeks, up to 100 weeks
Title
Time to LCSS Symptomatic Progression
Description
Quality of life (QoL) assessment was performed by using a questionnaire according to The Lung Cancer Symptom Scale (LCSS) . The LCSS is designed as a disease and site-specific measure of QoL particularly for use in clinical trials. It evaluates six major symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain) associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global QoL. Within this trial the questionnaire according to LCSS was only recorded by the patient (patient's scale). QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100 (0 representing the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all six major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.
Time Frame
from the date of randomization to the date of the LCSS assessment on which symptomatic progression was identified, assessed on cycle 2, cycle 4 and cycle 6 (each cycle lasted 21 days)
Title
Evaluation of Medical Care Utilization in the Two Treatment Arms
Description
Medical resource use data collected will be used in health economic analyses where it may be combined with other data from other sources such as cost data or other clinical parameters.
Time Frame
Assessed every 6-12 weeks, up to 100 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have previously received anthracyclines should not receive doxorubicin ECOG Performance Status 0 - 2 Life expectancy of ≥ 12 weeks Adequate baseline bone marrow, hepatic and renal function, defined as follows: Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL Bilirubin ≤ 1.5 x ULN AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis Serum creatinine < 1.5 x ULN Measurable or non-measurable disease according to MPM-modified RECIST criteria Patients may have had prior therapy providing the following conditions are met: Surgery: wash-out period of 14 days Systemic and radiation anti-tumor therapy: wash-out period of 28 days Patients must give written informed consent to participate in the study Exclusion Criteria: Patients must not receive any other investigational agents while on study Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication Uncontrolled hypertension QTc interval (congenital or acquired) > 450 ms 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Lambiase, MD
Organizational Affiliation
AGC Biologics S.p.A.
Official's Role
Study Director
Facility Information:
Facility Name
Wilshire Oncology Medical Group
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
City of Hope-Comprehensive Cancer Cente
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
H. Lee Moffitt ancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UTsouthwestern medical center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liège
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitarie St. Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UAB - Alberta Cancer Board - Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z2
Country
Canada
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Facility Name
Hôpitaux de Marseille Hôpital Nord
City
Marseille
ZIP/Postal Code
Cedex 20
Country
France
Facility Name
St James's Hospital
City
Dublin
Country
Ireland
Facility Name
Ospedale Santo Spirito
City
Casale Monferrato
State/Province
Alessandria
ZIP/Postal Code
15033
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Luigi Gonzaga
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
City
Alessandria
ZIP/Postal Code
15100
Country
Italy
Facility Name
Centro di Riferimento Oncologico
City
Aviano
Country
Italy
Facility Name
Ospedale Valduce
City
Como
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi di Firenze
City
Firenze
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione San Raffaele del Monte Tabor
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Parma
City
Parma
Country
Italy
Facility Name
Azienda Unità Sanitaria locale di Ravenna
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
A.O. Salvini Garbagnate, Ospedale di Rho
City
Rho
Country
Italy
Facility Name
Azienda Ospedaliera Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
St. Jansdal Hospital
City
Harderwijk
State/Province
Gelderland
ZIP/Postal Code
3840
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435
Country
Netherlands
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80211
Country
Poland
Facility Name
Maria Sklodowska Memorial Cancer Center and Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
The University Hospital
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Chest Clinic, Wythenshawe Hospital
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Kent Oncology Centre Maidstone Hospital
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
University Hospitals of Leicester
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE0116
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Middlesex
State/Province
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre, Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
Sutton
State/Province
Surrey
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29753703
Citation
Gregorc V, Gaafar RM, Favaretto A, Grossi F, Jassem J, Polychronis A, Bidoli P, Tiseo M, Shah R, Taylor P, Novello S, Muzio A, Bearz A, Greillier L, Fontana F, Salini G, Lambiase A, O'Brien M. NGR-hTNF in combination with best investigator choice in previously treated malignant pleural mesothelioma (NGR015): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2018 Jun;19(6):799-811. doi: 10.1016/S1470-2045(18)30193-1. Epub 2018 May 9.
Results Reference
derived

Learn more about this trial

NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed

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