A Phase 2 interventional study of Erlotinib in Non-Squamous Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 29 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-08.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 264 is above the median of 60 across 5,296 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:
Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.
Drug: Erlotinib
Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
Also known as: Tarceva
Number of Differentially Expressed Genes Associated With Clinical Benefit
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5.
Time frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.
Time frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Number of KRAS Mutation Participants Who Achieved Clinical Benefit
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.
Time frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)
Tumor response was defined as either a CR or a PR prior to failure (disease progression, death from any cause, or a second malignancy). CR was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR was defined as a greater than or equal to 50 percent (%) reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.
Time frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST
Clinical benefit was defined as either a CR, PR, or SD prior to failure (disease progression, death from any cause, or a second malignancy). CR: complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR: greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. PD: unequivocal progression of existing non-target lesions.
Time frame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
| Milestone | Erlotinib |
|---|---|
| Started | 264 |
| Safety analysis population (sap) | 261 |
| Completed | 0 |
| Not completed | 264 |
| Withdrew: Lack of efficacy | 199 |
| Withdrew: Death | 29 |
| Withdrew: Adverse event/intercurrent illness | 16 |
| Withdrew: Refused treatment/did not cooperate | 9 |
| Withdrew: Administrative reasons | 6 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Protocol violation | 2 |
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5.
| genes | Erlotinib |
|---|---|
| Number of Differentially Expressed Genes Associated With Clinical Benefit | 0 |
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.
| participants | Erlotinib |
|---|---|
| Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit | 6 |
Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.
| participants | Erlotinib |
|---|---|
| Number of KRAS Mutation Participants Who Achieved Clinical Benefit | 4 |
Tumor response was defined as either a CR or a PR prior to failure (disease progression, death from any cause, or a second malignancy). CR was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR was defined as a greater than or equal to 50 percent (%) reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.
| percentage of participants | Erlotinib |
|---|---|
| Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST) | 15.2 (11.1 to 20.1) |
Clinical benefit was defined as either a CR, PR, or SD prior to failure (disease progression, death from any cause, or a second malignancy). CR: complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR: greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. PD: unequivocal progression of existing non-target lesions.
| percentage of participants | Erlotinib |
|---|---|
| Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST | 31.4 (25.9 to 37.4) |
Collected over Up to 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib | — | 65/261 (24.9%) | 209/261 (80.1%) |
| Event | Erlotinib |
|---|---|
| PneumoniaInfections and infestations | 12/261 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 11/261 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 5/261 |
| AstheniaGeneral disorders | 3/261 |
| General physical health deteriorationGeneral disorders | 3/261 |
| PyrexiaGeneral disorders | 3/261 |
| DiarrhoeaGastrointestinal disorders | 3/261 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 2/261 |
| Urinary tract infectionInfections and infestations | 2/261 |
| VomitingGastrointestinal disorders | 2/261 |
| Event | Erlotinib |
|---|---|
| RashSkin and subcutaneous tissue disorders | 133/261 |
| DiarrhoeaGastrointestinal disorders | 84/261 |
| AnorexiaMetabolism and nutrition disorders | 41/261 |
| CoughRespiratory, thoracic and mediastinal disorders | 39/261 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 37/261 |
| Dry skinSkin and subcutaneous tissue disorders | 33/261 |
| PruritusSkin and subcutaneous tissue disorders | 32/261 |
| FatigueGeneral disorders | 32/261 |
| VomitingGastrointestinal disorders | 26/261 |
| NauseaGastrointestinal disorders | 23/261 |
Analysis population included all enrolled participants.
| Age, Continuous(years) | Erlotinib |
|---|---|
| Mean | 60.8 ± 10.47 |
| Sex: Female, Male(Participants) | Erlotinib |
|---|---|
| Female | 80 |
| Male | 184 |
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hoffmann-La Roche