Clinical Trial Results:
Erlotinib treatment beyond progression in EGFR mutant or patients who have responded to EGFR TKI in stage IIIB/IV NSCLC
Summary
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EudraCT number |
2013-002049-13 |
Trial protocol |
FI |
Global end of trial date |
31 Dec 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Nov 2021
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First version publication date |
16 Nov 2021
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Other versions |
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Summary report(s) |
Final report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
843
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Oulu Univeristy Hospital
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Sponsor organisation address |
Kajaanintie 50, Oulu, Finland, 90220
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Public contact |
Jussi Koivunen, Oulu University Hospital, 358 83153789, jussi.koivunen@ppshp.fi
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Scientific contact |
Jussi Koivunen, Oulu University Hospital, 358 83153789, jussi.koivunen@ppshp.fi
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Jun 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Dec 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To study efficacy and safety of Erlotinib treatment beyound diasease progression in combination with chemotherapy compared to chemotherapy alone in stage IIIB/IV non-small cell lung cancer patients with EGFR activating mutations or who have responded EGFR TKIs-
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Protection of trial subjects |
The trial was approved by PPSHP ethics committee (55/2013, EudraCT 2013-002049-13) and national competent authority (77/2013) and was carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All patients provided written informed consent before any study-related procedures.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
9
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From 65 to 84 years |
9
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85 years and over |
0
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Recruitment
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Recruitment details |
18 out of planned 80 subject were recruited for the study. | |||||||||
Pre-assignment
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Screening details |
E | |||||||||
Period 1
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Period 1 title |
Recruitement (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Chemotherapy | |||||||||
Arm description |
Chemoterapy treatment | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Chemotherapy (multiple products)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
According to nationals guidelines
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Arm title
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Chemotherapy+Erlotinib | |||||||||
Arm description |
Chemotherapy+Erlotinib | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Chemotherapy (multiple products)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
According to national guidelines
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Investigational medicinal product name |
Erlotinib
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Investigational medicinal product code |
183320-12-9
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
150mg x1 d5-18 Q3W for cycles 1-5 and thereafter daily 150mg x1
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Baseline characteristics reporting groups
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Reporting group title |
Chemotherapy
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Reporting group description |
Chemoterapy treatment | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Chemotherapy+Erlotinib
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Reporting group description |
Chemotherapy+Erlotinib | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Chemotherapy
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Reporting group description |
Chemoterapy treatment | ||
Reporting group title |
Chemotherapy+Erlotinib
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Reporting group description |
Chemotherapy+Erlotinib |
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End point title |
PFS (median) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Progression-free survival (median)
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Statistical analysis title |
Statistical analysis | ||||||||||||
Comparison groups |
Chemotherapy v Chemotherapy+Erlotinib
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Number of subjects included in analysis |
18
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Logrank | ||||||||||||
Parameter type |
Risk ratio (RR) | ||||||||||||
Confidence interval |
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level |
95% | ||||||||||||
sides |
1-sided
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lower limit |
- | ||||||||||||
upper limit |
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Variability estimate |
Standard deviation
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End point title |
OS (median) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Overall survival (median)
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No statistical analyses for this end point |
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End point title |
ORR | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
ORR
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From the date of IC to final visit (1-4motnhs after study treatment completion)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17
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Reporting groups
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Reporting group title |
Chemotherapy
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Reporting group description |
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Reporting group title |
Chemotherapy+erlotinib
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Reporting group description |
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The study only collected serious adverse events |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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04 Jan 2016 |
Increase the time of recruitement period to 31.12.2016 |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |