A Phase 2 interventional study of NGR-hTNF and Doxorubicin in Small Cell Lung Cancer, sponsored by AGC Biologics S.p.A.. Completed at 5 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by AGC Biologics S.p.A. · Phase 2, Interventional, and Treatment
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.
1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.
This study's enrollment of 28 is below the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →AGC Biologics S.p.A. is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Adequate baseline bone marrow, hepatic and renal function, defined as follows:
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
Exclusion Criteria:
NGR-hTNF plus doxorubicin
Drug: NGR-hTNF · Drug: Doxorubicin
iv q3W 0.8 mcg/sqm NGR-hTNF
iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion
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
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
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.
Time frame: 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.
Time frame: Through study completion, an average of 3 years
Experimental Imaging Study (DCE-MRI)
To document possible modifications on vessels permeability by imaging techniques
Time frame: 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)
Time frame: Through study completion, an average of 3 years
Study period: February 14th, 2007 (first enrolment), April 23rd, 2010(last enrolment); May 17th, 2011(LPLV) 5 clinical sites in Italy
| Milestone | A: NGR-hTNF + Doxorubicin |
|---|---|
| Started | 28 |
| Completed | 28 |
| Not completed | 0 |
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
| months | A: NGR-hTNF + Doxorubicin |
|---|---|
| Antitumour Activity Defined as Progression Free Survival (PFS) | 3.2 (1.8 to 4.7) |
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.
| Participants | A: NGR-hTNF + Doxorubicin |
|---|---|
| Complete Response (CR) | 0 |
| Partial Response(PR) | 7 |
| Stable disease | 8 |
| Progressive disease (PD) | 10 |
| Not assessable | 3 |
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.
| months | A: NGR-hTNF + Doxorubicin |
|---|---|
| Overall Survival (OS) | 5.6 (5.3 to 5.9) |
To document possible modifications on vessels permeability by imaging techniques
No measurements were reported for this outcome.
Evaluation according to NCI common terminology criteria for adverse events (version 3.0)
| Event | A: NGR-hTNF + Doxorubicin |
|---|---|
| NGR-hTNF Related Adverse Event | 27 |
| Adverse Event | 349 |
| Serious Adverse Event | 12 |
| Doxorubicin AE Related Adverse Event | 206 |
| NGR-hTNF + Doxorubicin Related Adverse Event | 4 |
Collected over Through study completion, an average of 3 years. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A: NGR-hTNF + Doxorubicin | 28/28 (100%) | 7/28 (25%) | 28/28 (100%) |
| Event | A: NGR-hTNF + Doxorubicin |
|---|---|
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/28 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/28 |
| NeutopeniaBlood and lymphatic system disorders | 1/28 |
| AnaemiaBlood and lymphatic system disorders | 1/28 |
| SeizureNervous system disorders | 1/28 |
| Infectious FeverGeneral disorders | 1/28 |
| Mucosal InflammationGeneral disorders | 1/28 |
| EnteritisGastrointestinal disorders | 1/28 |
| StomatitisGastrointestinal disorders | 1/28 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 1/28 |
| Event | A: NGR-hTNF + Doxorubicin |
|---|---|
| LeukopeniaBlood and lymphatic system disorders | 18/28 |
| NeutropeniaBlood and lymphatic system disorders | 17/28 |
| AnaemiaBlood and lymphatic system disorders | 16/28 |
| ChillsGeneral disorders | 15/28 |
| FatigueGeneral disorders | 13/28 |
| LymphopeniaBlood and lymphatic system disorders | 12/28 |
| NauseaGastrointestinal disorders | 12/28 |
| ThrombocytopeniaBlood and lymphatic system disorders | 10/28 |
| AnorexiaMetabolism and nutrition disorders | 10/28 |
| PyrexiaGeneral disorders | 8/28 |
patients affected by advanced or metastatic Small Cell Lung Carcinoma (SCLC) previously treated with at least one therapeutic regimen
| Age, Categorical(Participants) | A: NGR-hTNF + Doxorubicin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 12 |
| Age, Continuous(years) | A: NGR-hTNF + Doxorubicin |
|---|---|
| Median | 62.5 (41.0 to 76.0) |
| Sex: Female, Male(Participants) | A: NGR-hTNF + Doxorubicin |
|---|---|
| Female | 9 |
| Male | 19 |
| Region of Enrollment(participants) | A: NGR-hTNF + Doxorubicin |
|---|---|
| Italy | 28 |
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Tumor necrosis factor-alpha, CNGRC fusion protein, human · Doxorubicin
AGC Biologics S.p.A.