Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

NGR-hTNF

iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion

Antonio Lambiase, MD

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

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 of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma

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

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

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.

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.

To document possible modifications on vessels permeability by imaging techniques

Evaluation according to NCI common terminology criteria for adverse events (version 3.0)

AGC Biologics S.p.A.

NGR-hTNF plus doxorubicin

NGR-hTNF: iv q3W 0.8 mcg/sqm NGR-hTNF

Doxorubicin: iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion

A: NGR-hTNF + Doxorubicin

NGR-hTNF plus doxorubicin

NGR-hTNF: iv q3W 0.8 mcg/sqm

Doxorubicin: iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion

Age, Categorical

Age, Continuous

Sex: Female, Male

Italy

Region of Enrollment

patients affected by advanced or metastatic Small Cell Lung Carcinoma (SCLC) previously treated with at least one therapeutic regimen

Clinical Operations

Antitumour Activity Defined as Progression Free Survival (PFS)

Complete Response (CR)

Partial Response(PR)

Stable disease

Progressive disease (PD)

Not assessable

Tumor Growth Control Rate (TGCR)

Overall Survival (OS)

Though a DCE-MRI evaluation was planned by protocol for a selected number of patients, no DCE-MRI assessments were performed.

Spots Global Cancer Trial Database for Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial