Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations (NCT NCT01609543)
NCT ID: NCT01609543
Last Updated: 2016-02-01
Results Overview
PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.
COMPLETED
PHASE4
62 participants
Baseline to progressive disease or death (up to 34 months)
2016-02-01
Participant Flow
A total of 651 participants were screened and among them 62 participants were enrolled in the study.
Participant milestones
| Measure |
Erlotinib Hydrochloride
Participants received a single 150 milligrams (mg) oral dose of erlotinib hydrochloride (Tarceva) tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
42
|
Reasons for withdrawal
| Measure |
Erlotinib Hydrochloride
Participants received a single 150 milligrams (mg) oral dose of erlotinib hydrochloride (Tarceva) tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
|
|---|---|
|
Overall Study
Disease Progression
|
28
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Death
|
7
|
Baseline Characteristics
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
Baseline characteristics by cohort
| Measure |
Erlotinib Hydrochloride
n=62 Participants
Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
|
|---|---|
|
Age, Continuous
|
67.69 Years
STANDARD_DEVIATION 10.562 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to progressive disease or death (up to 34 months)Population: ITT population.
PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours \[RECIST\] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.
Outcome measures
| Measure |
Erlotinib Hydrochloride
n=62 Participants
Participants received a single 150 mg oral dose erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity, or consent withdrawal, whichever occurred first up to 34 months.
|
|---|---|
|
Progression-Free Survival (PFS)
|
12.846 Months
Interval 9.901 to 15.791
|
SECONDARY outcome
Timeframe: Baseline to progressive disease or death (up to 34 months)Population: ITT population.
BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than \[\<\] 10 millimeters \[mm\] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Erlotinib Hydrochloride
n=62 Participants
Participants received a single 150 mg oral dose erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity, or consent withdrawal, whichever occurred first up to 34 months.
|
|---|---|
|
Percentage of Participants With Best Overall Response (BOR)
CR
|
1.8 Percentage of Participants
|
|
Percentage of Participants With Best Overall Response (BOR)
PR
|
64.3 Percentage of Participants
|
|
Percentage of Participants With Best Overall Response (BOR)
SD
|
32.1 Percentage of Participants
|
|
Percentage of Participants With Best Overall Response (BOR)
PD
|
1.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: 1 Year (12 months)Population: ITT population. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.
Outcome measures
| Measure |
Erlotinib Hydrochloride
n=40 Participants
Participants received a single 150 mg oral dose erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity, or consent withdrawal, whichever occurred first up to 34 months.
|
|---|---|
|
Percentage of Participants Who Were Alive at 1 Year
|
82.5 Percentage of Participants
|
Adverse Events
Erlotinib Hydrochloride
Serious adverse events
| Measure |
Erlotinib Hydrochloride
n=62 participants at risk
Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Cardiac disorders
Atrial Fibrillation
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Cardiac disorders
Pericardial Effusion
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
5/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Gastrointestinal disorders
Ileus Paralytic
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
3/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
General disorders
Asthenia
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
General disorders
Chest Pain
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
General disorders
Pain
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
General disorders
Pyrexia
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
General disorders
Sudden Cardiac Death
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Hepatobiliary disorders
Liver Injury
|
3.2%
2/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Investigations
Alanine Aminotransferase Increased
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Investigations
Aspartate Aminotransferase Increased
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Investigations
Liver Function Test Abnormal
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
2/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.2%
2/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected Neoplasm
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Nervous system disorders
Balance Disorder
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Nervous system disorders
Headache
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Renal and urinary disorders
Haematuria
|
3.2%
2/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Renal and urinary disorders
Renal Failure
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
2/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.2%
2/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.1%
5/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
1.6%
1/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
Other adverse events
| Measure |
Erlotinib Hydrochloride
n=62 participants at risk
Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.1%
5/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Eye disorders
Growth of Eyelashes
|
8.1%
5/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
27.4%
17/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Gastrointestinal disorders
Nausea
|
6.5%
4/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
General disorders
Asthenia
|
8.1%
5/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Infections and infestations
Conjunctivitis
|
9.7%
6/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
8.1%
5/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Investigations
Weight Decreased
|
6.5%
4/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.5%
4/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
11.3%
7/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Nervous system disorders
Headache
|
8.1%
5/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
8/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.1%
5/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.3%
7/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
17.7%
11/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.5%
9/62 • Baseline up to 28 days after the last dose of study medication (up to 34 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
58.1%
36/62 • Baseline up to 28 days after the last dose of study medication (up to 34 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