Trial Outcomes & Findings for A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib) (NCT NCT00854308)
NCT ID: NCT00854308
Last Updated: 2017-03-31
Results Overview
Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
137 participants
Primary outcome timeframe
Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)
Results posted on
2017-03-31
Participant Flow
Twenty-seven patients in the placebo + erlotinib arm with disease progression in the blinded treatment stage elected to receive MetMAb + erlotinib in the optional open-label phase of the study.
Participant milestones
| Measure |
MetMAb + Erlotinib
MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
|
Placebo + Erlotinib
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
68
|
|
Overall Study
Received Study Drug
|
69
|
67
|
|
Overall Study
COMPLETED
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
62
|
67
|
Reasons for withdrawal
| Measure |
MetMAb + Erlotinib
MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
|
Placebo + Erlotinib
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Disease progression
|
42
|
50
|
|
Overall Study
Adverse Event
|
8
|
3
|
|
Overall Study
Death
|
2
|
5
|
|
Overall Study
Physician Decision
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Sponsor's decision to terminate study
|
0
|
1
|
Baseline Characteristics
A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
Baseline characteristics by cohort
| Measure |
MetMAb + Erlotinib
n=69 Participants
MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
|
Placebo + Erlotinib
n=68 Participants
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)Population: All randomized intent-to-treat patients.
Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
Outcome measures
| Measure |
MetMAb + Erlotinib
n=69 Participants
MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
|
Placebo + Erlotinib
n=68 Participants
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival
|
2.2 months
Interval 1.38 to 2.86
|
2.6 months
Interval 1.45 to 2.76
|
PRIMARY outcome
Timeframe: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)Population: All randomized intent-to-treat patients with Met Diagnostic-Positive tumors.
Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry. PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
Outcome measures
| Measure |
MetMAb + Erlotinib
n=35 Participants
MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
|
Placebo + Erlotinib
n=31 Participants
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival in Patients With Met Diagnostic-Positive Tumors
|
2.9 months
Interval 1.38 to 6.21
|
1.5 months
Interval 1.35 to 2.63
|
SECONDARY outcome
Timeframe: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)Population: All randomized intent-to-treat patients.
Objective response (partial and complete response as determined using RECIST 1.0). Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. Complete response was defined as disappearance of all target lesions.
Outcome measures
| Measure |
MetMAb + Erlotinib
n=69 Participants
MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
|
Placebo + Erlotinib
n=68 Participants
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Objective Response
|
5.8 Percentage of participants
Interval 2.0 to 13.9
|
4.4 Percentage of participants
Interval 1.2 to 11.7
|
SECONDARY outcome
Timeframe: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)Population: All randomized intent-to-treat patients with Met Diagnostic-positive tumors.
Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry. Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. Complete response was defined as disappearance of all target lesions.
Outcome measures
| Measure |
MetMAb + Erlotinib
n=35 Participants
MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
|
Placebo + Erlotinib
n=31 Participants
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors
|
8.6 Percentage of participants
Interval 2.4 to 21.5
|
3.2 Percentage of participants
Interval 0.2 to 16.1
|
SECONDARY outcome
Timeframe: Date of initial response until date of progression or death on study. (Up to 20 months)Population: All randomized intent-to-treat patients. Analyses of duration of response were not performed because of the small number of patients with objective responses.
Outcome measures
Outcome data not reported
Adverse Events
MetMAb + Erlotinib
Serious events: 29 serious events
Other events: 68 other events
Deaths: 0 deaths
Placebo + Erlotinib
Serious events: 22 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MetMAb + Erlotinib
n=69 participants at risk
MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
|
Placebo + Erlotinib
n=67 participants at risk
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.4%
1/69 • Up to 20 months
|
3.0%
2/67 • Up to 20 months
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Cardiac disorders
CARDIAC ARREST
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Cardiac disorders
TACHYCARDIA
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
General disorders
ASTHENIA
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
General disorders
DEATH
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
General disorders
HERNIA OBSTRUCTIVE
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
General disorders
PAIN
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
General disorders
PYREXIA
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Infections and infestations
PNEUMONIA
|
5.8%
4/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Infections and infestations
LUNG INFECTION
|
1.4%
1/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Infections and infestations
CELLULITIS
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.4%
1/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Nervous system disorders
SYNCOPE
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
5.8%
4/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
4.3%
3/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
1.4%
1/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
2.9%
2/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/69 • Up to 20 months
|
3.0%
2/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.4%
1/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/69 • Up to 20 months
|
3.0%
2/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ARTERY THROMBOSIS
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
|
Skin and subcutaneous tissue disorders
RASH
|
2.9%
2/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Vascular disorders
EMBOLISM VENOUS
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Vascular disorders
SUPERIOR VENA CAVAL OCCLUSION
|
1.4%
1/69 • Up to 20 months
|
0.00%
0/67 • Up to 20 months
|
Other adverse events
| Measure |
MetMAb + Erlotinib
n=69 participants at risk
MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
|
Placebo + Erlotinib
n=67 participants at risk
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
14.5%
10/69 • Up to 20 months
|
14.9%
10/67 • Up to 20 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
40.6%
28/69 • Up to 20 months
|
52.2%
35/67 • Up to 20 months
|
|
Gastrointestinal disorders
NAUSEA
|
31.9%
22/69 • Up to 20 months
|
31.3%
21/67 • Up to 20 months
|
|
Gastrointestinal disorders
VOMITING
|
5.8%
4/69 • Up to 20 months
|
19.4%
13/67 • Up to 20 months
|
|
Gastrointestinal disorders
DYSPEPSIA
|
7.2%
5/69 • Up to 20 months
|
9.0%
6/67 • Up to 20 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.8%
4/69 • Up to 20 months
|
7.5%
5/67 • Up to 20 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
7.2%
5/69 • Up to 20 months
|
3.0%
2/67 • Up to 20 months
|
|
Gastrointestinal disorders
STOMATITIS
|
5.8%
4/69 • Up to 20 months
|
4.5%
3/67 • Up to 20 months
|
|
General disorders
FATIGUE
|
31.9%
22/69 • Up to 20 months
|
35.8%
24/67 • Up to 20 months
|
|
General disorders
OEDEMA PERIPHERAL
|
23.2%
16/69 • Up to 20 months
|
7.5%
5/67 • Up to 20 months
|
|
General disorders
PYREXIA
|
14.5%
10/69 • Up to 20 months
|
9.0%
6/67 • Up to 20 months
|
|
General disorders
ASTHENIA
|
13.0%
9/69 • Up to 20 months
|
9.0%
6/67 • Up to 20 months
|
|
General disorders
PAIN
|
5.8%
4/69 • Up to 20 months
|
11.9%
8/67 • Up to 20 months
|
|
General disorders
CHEST PAIN
|
2.9%
2/69 • Up to 20 months
|
10.4%
7/67 • Up to 20 months
|
|
General disorders
OEDEMA
|
8.7%
6/69 • Up to 20 months
|
3.0%
2/67 • Up to 20 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.8%
4/69 • Up to 20 months
|
9.0%
6/67 • Up to 20 months
|
|
Infections and infestations
PNEUMONIA
|
7.2%
5/69 • Up to 20 months
|
4.5%
3/67 • Up to 20 months
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
20.3%
14/69 • Up to 20 months
|
23.9%
16/67 • Up to 20 months
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
5.8%
4/69 • Up to 20 months
|
7.5%
5/67 • Up to 20 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.1%
7/69 • Up to 20 months
|
10.4%
7/67 • Up to 20 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.2%
5/69 • Up to 20 months
|
4.5%
3/67 • Up to 20 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
5.8%
4/69 • Up to 20 months
|
4.5%
3/67 • Up to 20 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
5.8%
4/69 • Up to 20 months
|
4.5%
3/67 • Up to 20 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
2.9%
2/69 • Up to 20 months
|
6.0%
4/67 • Up to 20 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.9%
2/69 • Up to 20 months
|
6.0%
4/67 • Up to 20 months
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
1.4%
1/69 • Up to 20 months
|
6.0%
4/67 • Up to 20 months
|
|
Nervous system disorders
DIZZINESS
|
7.2%
5/69 • Up to 20 months
|
9.0%
6/67 • Up to 20 months
|
|
Nervous system disorders
DYSGEUSIA
|
4.3%
3/69 • Up to 20 months
|
6.0%
4/67 • Up to 20 months
|
|
Nervous system disorders
HEADACHE
|
2.9%
2/69 • Up to 20 months
|
6.0%
4/67 • Up to 20 months
|
|
Psychiatric disorders
ANXIETY
|
8.7%
6/69 • Up to 20 months
|
10.4%
7/67 • Up to 20 months
|
|
Psychiatric disorders
INSOMNIA
|
11.6%
8/69 • Up to 20 months
|
7.5%
5/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
18.8%
13/69 • Up to 20 months
|
23.9%
16/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
18.8%
13/69 • Up to 20 months
|
19.4%
13/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
8.7%
6/69 • Up to 20 months
|
7.5%
5/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
5.8%
4/69 • Up to 20 months
|
3.0%
2/67 • Up to 20 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
5.8%
4/69 • Up to 20 months
|
1.5%
1/67 • Up to 20 months
|
|
Skin and subcutaneous tissue disorders
RASH
|
60.9%
42/69 • Up to 20 months
|
61.2%
41/67 • Up to 20 months
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
14.5%
10/69 • Up to 20 months
|
14.9%
10/67 • Up to 20 months
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
11.6%
8/69 • Up to 20 months
|
14.9%
10/67 • Up to 20 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
5.8%
4/69 • Up to 20 months
|
11.9%
8/67 • Up to 20 months
|
|
Vascular disorders
HYPOTENSION
|
8.7%
6/69 • Up to 20 months
|
4.5%
3/67 • Up to 20 months
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
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