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A Study of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer (PENGUIN)

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ClinicalTrials.gov Identifier: NCT00855894
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : May 1, 2013
Last Update Posted : May 21, 2013
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Interventions Drug: Pertuzumab
Drug: Erlotinib
Enrollment 41
Recruitment Details  
Pre-assignment Details Patients were considered to have completed the study if they were alive at their last survival follow-up visit prior to 10 Nov 2011, which was 1 year after the last patient was enrolled, or they were continuing treatment per Amendment 3 of the study protocol (1 patient).
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
Period Title: Overall Study
Started 41
Completed 8
Not Completed 33
Reason Not Completed
Death             31
Patient's decision             1
Disease progression             1
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
60.7  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
17
  41.5%
Male
24
  58.5%
1.Primary Outcome
Title Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups
Hide Description The assessment of FDG-PET response was performed by a central reading site. PET response was based on the maximum standard uptake value (SUVmax) of up to 5 regions of interest (ROI). The tumor ROIs were identified for each patient on pretreatment FDG-PET scans and corresponded to a subset of the target lesions identified for Response Evaluation Criteria for Solid Tumors (RECIST) analysis. Specifically, the SUVmax of each ROI on the on-treatment scans was compared with the SUVmax on the corresponding pretreatment scan and the percent change was calculated. When there was more than 1 ROI, the overall percent change in SUVmax was the arithmetic mean of the percent changes in SUVmax for each of the ROIs (mSUVmax). An PET response is defined as a decrease of ≥ 20% in mSUVmax. EGFR mutation status was assessed in tumor tissue samples taken from each patient.
Time Frame Baseline to Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
All 41 patients treated with pertuzumab and erlotinib were evaluable for analysis. Patients with a missing Day 56 assessment were deemed non-responders. Tumor tissue samples were only available for 32 patients for EGFR mutation status analysis.
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
In all patients
19.5
(9.2 to 33.9)
In patients with EGFR mutation(s), n=9
66.7
(29.9 to 90.2)
In patients with wild-type EGFR, n=23
8.7
(1.6 to 26.8)
2.Secondary Outcome
Title Progression-free Survival (PFS)
Time Frame Baseline to the end of the study (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All 41 patients treated with erlotinib and pertuzumab. Patients who had not progressed or died at the time of analysis for PFS were censored at the date of their last tumor assessment.
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
Overall Number of Participants Analyzed 41
Median (95% Confidence Interval)
Unit of Measure: Months
1.9
(1.87 to 3.38)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the time from the date of first dosing with pertuzumab and erlotinib until the date of patient death from any cause.
Time Frame Baseline to the end of the study (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All 41 patients treated with erlotinib and pertuzumab. Patients who had not died at the time of analysis for OS were censored at the date of last contact.
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
Overall Number of Participants Analyzed 41
Median (95% Confidence Interval)
Unit of Measure: Months
8.7
(4.70 to 9.99)
4.Secondary Outcome
Title Percentage of Patients With an Objective Response (OR)
Hide Description OR was defined as a complete response (CR) or a partial response (PR) as determined by the investigator and based on computed tomography (CT) using Response Evaluation Criteria in Solid Tumors (RECIST) on 2 consecutive occasions at least 4 weeks apart. A complete response was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. A partial response was defined as ≥ 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or the persistence of 1 or more non-target lesions and/or the maintenance of a tumor marker level above the normal limits.
Time Frame Baseline to the end of the study (up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All 41 patients treated with erlotinib and pertuzumab.
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
7.3
(2.0 to 19.0)
5.Secondary Outcome
Title Percentage of Patients With Disease Control (DC) at Day 56
Hide Description DC was defined as a CR, a PR, or stable disease (SD) as determined by the investigator and based on CT using RECIST. A CR was defined as the disappearance of all target (TL) and non-target lesions (nTL). A PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline sum longest diameter, or the persistence of 1 or more nTLs and/or maintenance of a tumor marker level (TML) above normal limits. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (SSLD) since treatment started. For nTLs, SD was defined as the persistence of 1 or more lesions and/or maintenance of a TML above normal limits. PD was defined as ≥ 20% increase in the SLD of TLs, taking as reference the SSLD recorded since treatment started, the appearance of 1 or more new lesions, or the unequivocal progression of existing nTLs.
Time Frame Baseline to Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
All 41 patients treated with erlotinib and pertuzumab.
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description:
Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
Overall Number of Participants Analyzed 41
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
31.7
(19.0 to 46.9)
Time Frame Adverse events (AE) were reported from the time of enrollment in the study up to 30 days after the last day of treatment or study discontinuation, whichever was later (up to 3 years).
Adverse Event Reporting Description Adverse events are reported for all patients who received at least 1 dose of study treatment.
 
Arm/Group Title Pertuzumab + Erlotinib
Hide Arm/Group Description Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
All-Cause Mortality
Pertuzumab + Erlotinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab + Erlotinib
Affected / at Risk (%)
Total   18/41 (43.90%) 
Blood and lymphatic system disorders   
Anaemia  1  1/41 (2.44%) 
Cardiac disorders   
Left ventricular dysfunction  1  1/41 (2.44%) 
Endocrine disorders   
Adrenal insufficiency  1  1/41 (2.44%) 
Gastrointestinal disorders   
Diarrhea  1  5/41 (12.20%) 
Vomiting  1  4/41 (9.76%) 
Pneumatosis intestinalis  1  3/41 (7.32%) 
Gastrointestinal haemorrhage  1  1/41 (2.44%) 
Lower gastrointestinal haemorrhage  1  1/41 (2.44%) 
Pancreatitis  1  1/41 (2.44%) 
General disorders   
Oedema peripheral  1  1/41 (2.44%) 
Pyrexia  1  1/41 (2.44%) 
Infections and infestations   
Infection  1  1/41 (2.44%) 
Pharyngeal abscess  1  1/41 (2.44%) 
Metabolism and nutrition disorders   
Dehydration  1  2/41 (4.88%) 
Hypoglycemia  1  1/41 (2.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor invasion  1  1/41 (2.44%) 
Nervous system disorders   
Cerebral haemorrhage  1  1/41 (2.44%) 
Sedation  1  1/41 (2.44%) 
Renal and urinary disorders   
Renal failure acute  1  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/41 (2.44%) 
Respiratory distress  1  1/41 (2.44%) 
Vascular disorders   
Orthostatic hypotension  1  1/41 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pertuzumab + Erlotinib
Affected / at Risk (%)
Total   41/41 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  3/41 (7.32%) 
Lymphopenia  1  3/41 (7.32%) 
Eye disorders   
Dry eye  1  7/41 (17.07%) 
Conjunctivitis  1  6/41 (14.63%) 
Gastrointestinal disorders   
Diarrhoea  1  36/41 (87.80%) 
Nausea  1  25/41 (60.98%) 
Vomiting  1  21/41 (51.22%) 
Stomatitis  1  7/41 (17.07%) 
Constipation  1  6/41 (14.63%) 
Abdominal pain  1  5/41 (12.20%) 
Dry mouth  1  5/41 (12.20%) 
Dyspepsia  1  3/41 (7.32%) 
General disorders   
Fatigue  1  28/41 (68.29%) 
Mucosal infalmmation  1  22/41 (53.66%) 
Oedema peripheral  1  5/41 (12.20%) 
Chest pain  1  3/41 (7.32%) 
Hepatobiliary disorders   
Hyperbilirubinaemia  1  3/41 (7.32%) 
Infections and infestations   
Paronychia  1  10/41 (24.39%) 
Upper respiratory tract infection  1  3/41 (7.32%) 
Investigations   
Weight decreased  1  9/41 (21.95%) 
Alanine aminotransferase increased  1  3/41 (7.32%) 
Metabolism and nutrition disorders   
Decreased appetite  1  26/41 (63.41%) 
Hypokalaemia  1  10/41 (24.39%) 
Dehydration  1  9/41 (21.95%) 
Hypomagnesaemia  1  8/41 (19.51%) 
Hypoalbumaemia  1  4/41 (9.76%) 
Hyperglycaemia  1  3/41 (7.32%) 
Hypophosphataemia  1  3/41 (7.32%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  3/41 (7.32%) 
Nervous system disorders   
Dysgeusia  1  9/41 (21.95%) 
Dizziness  1  4/41 (9.76%) 
Headache  1  3/41 (7.32%) 
Psychiatric disorders   
Depression  1  5/41 (12.20%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  11/41 (26.83%) 
Epistaxis  1  6/41 (14.63%) 
Rhinorrhoea  1  5/41 (12.20%) 
Skin and subcutaneous tissue disorders   
Rash  1  26/41 (63.41%) 
Dermatitis acneiform  1  9/41 (21.95%) 
Dry skin  1  9/41 (21.95%) 
Alopecia  1  5/41 (12.20%) 
Pruritus  1  5/41 (12.20%) 
Rash generalised  1  3/41 (7.32%) 
Skin exfoliation  1  3/41 (7.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Genentech, Inc.
Phone: 800 821-8590
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00855894     History of Changes
Other Study ID Numbers: TOC4603g
GO01357 ( Other Identifier: Hoffmann-La Roche )
First Submitted: March 4, 2009
First Posted: March 5, 2009
Results First Submitted: March 14, 2013
Results First Posted: May 1, 2013
Last Update Posted: May 21, 2013