Trial Outcomes & Findings for Safety and Effect of Pertuzumab in Patients With Advanced Non-Small Cell Lung Cancer, Which Has Progressed After Prior Chemotherapy (NCT NCT00063154)
NCT ID: NCT00063154
Last Updated: 2015-07-07
Results Overview
A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
COMPLETED
PHASE2
51 participants
Baseline to the end of the study (up to 1 year)
2015-07-07
Participant Flow
Participant milestones
| Measure |
Pertuzumab
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
Pertuzumab
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
|
|---|---|
|
Overall Study
Disease progression
|
27
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
10
|
|
Overall Study
Death
|
3
|
|
Overall Study
Reason unspecified
|
1
|
|
Overall Study
Did not receive treatment
|
8
|
Baseline Characteristics
Safety and Effect of Pertuzumab in Patients With Advanced Non-Small Cell Lung Cancer, Which Has Progressed After Prior Chemotherapy
Baseline characteristics by cohort
| Measure |
Pertuzumab
n=43 Participants
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
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|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of the study (up to 1 year)Population: Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.
A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Outcome measures
| Measure |
Pertuzumab
n=35 Participants
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
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|---|---|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Complete response
|
0.0 percentage of participants
|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Partial response
|
0.0 percentage of participants
|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Stable disease
|
51.4 percentage of participants
|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)
Progressive disease
|
48.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 1 year)Population: Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.
A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Outcome measures
| Measure |
Pertuzumab
n=38 Participants
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
|
|---|---|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Complete response pHER2+ (n=4)
|
0 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Partial response pHER2+ (n=4)
|
0 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Stable disease pHER2+ (n=4)
|
2 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Progressive disease pHER2+ (n=4)
|
1 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
No tumor assessment pHER2+ (n=4)
|
1 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Complete response pHER2- (n=34)
|
0 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
No tumor assessment pHER2- (n=34)
|
5 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Unable to evaluate response pHER2- (n=34)
|
1 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Unable to evaluate response pHER2+ (n=4)
|
0 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Partial response pHER2- (n=34)
|
0 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Stable disease pHER2- (n=34)
|
15 participants
|
|
Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors
Progressive disease pHER2- (n=34)
|
13 participants
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 1 year)Population: Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.
Progression-free survival was defined as the time from the first day of pertuzumab treatment (Cycle 1, Day 1) to the time of documented disease progression (per RECIST) or death, whichever occurred first.
Outcome measures
| Measure |
Pertuzumab
n=35 Participants
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
|
|---|---|
|
Progression-free Survival
|
6.6 weeks
Interval 6.0 to 14.7
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 1 year)Population: Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.
Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Pertuzumab
n=35 Participants
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
|
|---|---|
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Number of Participants Free From Disease Progression at 3, 6, and 12 Months
3 months
|
8 participants
|
|
Number of Participants Free From Disease Progression at 3, 6, and 12 Months
6 months
|
1 participants
|
|
Number of Participants Free From Disease Progression at 3, 6, and 12 Months
9 months
|
0 participants
|
Adverse Events
Pertuzumab
Serious adverse events
| Measure |
Pertuzumab
n=43 participants at risk
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
|
|---|---|
|
Infections and infestations
PNEUMONIA
|
16.3%
7/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Infections and infestations
CELLULITIS
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Infections and infestations
SEPSIS
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Gastrointestinal disorders
NAUSEA
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
General disorders
PAIN
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Immune system disorders
HYPERSENSITIVITY
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
2.3%
1/43
Safety population: All participants who received any amount of pertuzumab.
|
Other adverse events
| Measure |
Pertuzumab
n=43 participants at risk
Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
|
|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
34.9%
15/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Gastrointestinal disorders
NAUSEA
|
18.6%
8/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Gastrointestinal disorders
VOMITING
|
11.6%
5/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Gastrointestinal disorders
CONSTIPATION
|
9.3%
4/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Gastrointestinal disorders
STOMATITIS
|
9.3%
4/43
Safety population: All participants who received any amount of pertuzumab.
|
|
General disorders
FATIGUE
|
37.2%
16/43
Safety population: All participants who received any amount of pertuzumab.
|
|
General disorders
PAIN
|
14.0%
6/43
Safety population: All participants who received any amount of pertuzumab.
|
|
General disorders
PYREXIA
|
9.3%
4/43
Safety population: All participants who received any amount of pertuzumab.
|
|
General disorders
ASTHENIA
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
|
General disorders
CHILLS
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
|
General disorders
OEDEMA PERIPHERAL
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.0%
6/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
14.0%
6/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.6%
5/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.3%
4/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Psychiatric disorders
ANXIETY
|
14.0%
6/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Psychiatric disorders
INSOMNIA
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
18.6%
8/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Nervous system disorders
HEADACHE
|
11.6%
5/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Nervous system disorders
DIZZINESS
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Skin and subcutaneous tissue disorders
RASH
|
11.6%
5/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
|
Investigations
EJECTION FRACTION DECREASED
|
7.0%
3/43
Safety population: All participants who received any amount of pertuzumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER