Trial Outcomes & Findings for A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib) (NCT NCT02133508)
NCT ID: NCT02133508
Last Updated: 2017-10-24
Results Overview
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 diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to \<10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
COMPLETED
172 participants
Up to 8 months
2017-10-24
Participant Flow
A total of 172 participants were enrolled; 16 participants had protocol violations; 156 participants were eligible.
Participant milestones
| Measure |
NSCLC Participants
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
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|---|---|
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Overall Study
STARTED
|
156
|
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Overall Study
COMPLETED
|
141
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
NSCLC Participants
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
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|---|---|
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Overall Study
Decision of Investigator or Sponsor
|
1
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Overall Study
Death
|
12
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Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
A Study Examining Long Response in Lung Cancer Patients Treated With Tarceva (Erlotinib)
Baseline characteristics by cohort
| Measure |
NSCLC Participants
n=156 Participants
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
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|---|---|
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Age, Continuous
|
68.4 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
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60 Participants
n=5 Participants
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Sex: Female, Male
Male
|
96 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 8 monthsPopulation: All eligible participants
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 diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to \<10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Outcome measures
| Measure |
NSCLC Participants
n=156 Participants
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
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|---|---|
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Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
17.9 percentage of participants
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PRIMARY outcome
Timeframe: Up to 8 monthsPopulation: All eligible participants
The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to \<10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Outcome measures
| Measure |
NSCLC Participants
n=156 Participants
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
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|---|---|
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Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
≥8 Months
|
3.8 percentage of participants
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Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
<2 Months
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3.8 percentage of participants
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Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
2-5 Months
|
45.5 percentage of participants
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Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5-8 Months
|
28.8 percentage of participants
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SECONDARY outcome
Timeframe: Up to 8 monthsPopulation: All eligible participants
PFS was defined as the time from the beginning of therapy with erlotinib to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Outcome measures
| Measure |
NSCLC Participants
n=156 Participants
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
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|---|---|
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Progression-free Survival (PFS) According to RECIST v1.1
|
271.0 days
Interval 245.0 to 304.0
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SECONDARY outcome
Timeframe: Up to 8 monthsPopulation: All eligible participants
Overall survival was defined as the time from the beginning of therapy with erlotinib to death from any cause.
Outcome measures
| Measure |
NSCLC Participants
n=156 Participants
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
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|---|---|
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Overall Survival
|
NA months
The median value for overall survival was not estimable due to the low number of events during the observation period.
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SECONDARY outcome
Timeframe: Up to 8 monthsPopulation: All eligible participants
An AE is an unfavorable and unintended sign, symptom, or disease temporally associated with a clinical study, regardless of causality.
Outcome measures
| Measure |
NSCLC Participants
n=156 Participants
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
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|---|---|
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Percentage of Participants With Adverse Events (AEs)
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71.2 percentage of participants
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Adverse Events
NSCLC Participants
Serious adverse events
| Measure |
NSCLC Participants
n=156 participants at risk
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
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|---|---|
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Cardiac disorders
Atrial fibrillation
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0.64%
1/156 • Up to 8 months
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Cardiac disorders
Myocardial infarction
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0.64%
1/156 • Up to 8 months
|
|
Gastrointestinal disorders
Vomiting
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0.64%
1/156 • Up to 8 months
|
|
General disorders
Condition aggravated
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1.3%
2/156 • Up to 8 months
|
|
General disorders
Disease progression
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0.64%
1/156 • Up to 8 months
|
|
General disorders
General physical health deterioration
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1.9%
3/156 • Up to 8 months
|
|
General disorders
Pyrexia
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0.64%
1/156 • Up to 8 months
|
|
Infections and infestations
Klebsiella sepsis
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0.64%
1/156 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Brain oedema
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0.64%
1/156 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
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0.64%
1/156 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Femur fracture
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0.64%
1/156 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.64%
1/156 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
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0.64%
1/156 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
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0.64%
1/156 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.64%
1/156 • Up to 8 months
|
|
Nervous system disorders
Convulsion
|
0.64%
1/156 • Up to 8 months
|
|
Nervous system disorders
Seizure
|
0.64%
1/156 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.64%
1/156 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.64%
1/156 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.64%
1/156 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
2/156 • Up to 8 months
|
|
Vascular disorders
Intracranial hematoma
|
0.64%
1/156 • Up to 8 months
|
Other adverse events
| Measure |
NSCLC Participants
n=156 participants at risk
Participants with advanced non-small cell lung cancer (NSCLC), treated in second-line with erlotinib, presenting wild-type, not tested or unknown Epidermal Growth Factor Receptor (EGFR) status, and with stable disease at the first revaluation after start of erlotinib therapy.
|
|---|---|
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Gastrointestinal disorders
Diarrhoea
|
21.2%
33/156 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
39.7%
62/156 • Up to 8 months
|
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