A Phase 3 interventional study of Erlotinib in Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 4 sites in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-20.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 375 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
Drug: Erlotinib
Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study.
Daily oral doses administered until disease progression or unacceptable toxicity or death.
Also known as: Tarceva
Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.
Time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Proportion of Participants With Objective Response as Assessed by RECIST v 1.1
Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Proportion of Participants With Disease Control as Assessed by RECIST v 1.1
Disease control was defined as objective response or stable disease (SD) for at least 6 weeks. OR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of CR and PR four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 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.
Time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations
Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21.
Time frame: Screening up to approximately 7 days
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline up to approximately 4 years and 9 months
Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L)
The domains in the Quality of life score using the Functional Assessment of Cancer Therapy Lung (FACT-L) include physical, social/family, emotional, and functional well-being, and a lung cancer subscale include symptoms, cognitive function and regret of smoking. Minimum and maximum value of the scale is 0 and 4, respectively. Higher score indicate better health state.
Time frame: Baseline and end of study (approximately 4 years and 9 months)
| Milestone | Diagnostic Phase | Erlotinib |
|---|---|---|
| Started | 375 | 0 |
| Completed | 345 | 0 |
| Not completed | 30 | 0 |
| Withdrew: Started erlotinib in treatment period | 30 | 0 |
| Milestone | Diagnostic Phase | Erlotinib |
|---|---|---|
| Started | 0 | 30 |
| Completed | 0 | 27 |
| Not completed | 0 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Switch to commercial drug | 0 | 1 |
Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.
| months | Erlotinib |
|---|---|
| Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) | 9.574 (5.525 to 13.662) |
Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
| proportion of participants | Erlotinib |
|---|---|
| Proportion of Participants With Objective Response as Assessed by RECIST v 1.1 | 0.67 (0.49 to 0.81) |
Disease control was defined as objective response or stable disease (SD) for at least 6 weeks. OR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of CR and PR four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 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.
| proportion of participants | Erlotinib |
|---|---|
| Proportion of Participants With Disease Control as Assessed by RECIST v 1.1 | 0.97 (0.82 to 1.00) |
Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21.
| proportion of participants | Diagnostic Phase |
|---|---|
| Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations | 0.08 (0.06 to 0.11) |
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| percentage of participants | Erlotinib |
|---|---|
| Percentage of Participants With Adverse Events | 76.7 |
The domains in the Quality of life score using the Functional Assessment of Cancer Therapy Lung (FACT-L) include physical, social/family, emotional, and functional well-being, and a lung cancer subscale include symptoms, cognitive function and regret of smoking. Minimum and maximum value of the scale is 0 and 4, respectively. Higher score indicate better health state.
| unit on a scale | Erlotinib |
|---|---|
| Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L) | -2.83 ± NA |
Collected over 4 years and 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib | 1/30 (3.3%) | 6/30 (20%) | 22/30 (73.3%) |
| Event | Erlotinib |
|---|---|
| RashSkin and subcutaneous tissue disorders | 3/30 |
| ParonychiaSkin and subcutaneous tissue disorders | 1/30 |
| DeathGeneral disorders | 1/30 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 1/30 |
| Event | Erlotinib |
|---|---|
| RashSkin and subcutaneous tissue disorders | 14/30 |
| FatigueGeneral disorders | 4/30 |
| AnemiaBlood and lymphatic system disorders | 3/30 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/30 |
| DiarrheaGastrointestinal disorders | 3/30 |
| Dermatitis acneiformSkin and subcutaneous tissue disorders | 2/30 |
The intent-to-treat (ITT) population included all participants enrolled in the study.
| Age, Continuous(years) | Baseline Population |
|---|---|
| Diagnostic Phase | 62.2 ± 9.2 |
| Erlotinib | 62.4 ± 9.7 |
| Sex: Female, Male(Participants) | Baseline Population |
|---|---|
| Diagnostic Phase — Female | 133 |
| Diagnostic Phase — Male | 242 |
| Erlotinib — Female | 18 |
| Erlotinib — Male | 12 |
| Race (NIH/OMB)(Participants) | Baseline Population |
|---|---|
| Diagnostic Phase — American Indian or Alaska Native | 0 |
| Diagnostic Phase — Asian | 0 |
| Diagnostic Phase — Native Hawaiian or Other Pacific Islander | 0 |
| Diagnostic Phase — Black or African American | 0 |
| Diagnostic Phase — White | 375 |
| Diagnostic Phase — More than one race | 0 |
| Diagnostic Phase — Unknown or Not Reported | 0 |
| Erlotinib — American Indian or Alaska Native | 0 |
| Erlotinib — Asian | 0 |
| Erlotinib — Native Hawaiian or Other Pacific Islander | 0 |
| Erlotinib — Black or African American | 0 |
| Erlotinib — White | 30 |
| Erlotinib — More than one race | 0 |
| Erlotinib — Unknown or Not Reported | 0 |
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