A Phase 3 interventional study of Erlotinib [Tarceva] in Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Completed at 63 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-19.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 315 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Exclusion Criteria:
Erlotinib 150 mg single daily oral dose until disease progression.
Drug: Erlotinib [Tarceva]
Erlotinib 300 mg single daily oral dose until disease progression.
Drug: Erlotinib [Tarceva]
Single daily oral dose
Also known as: Tarceva
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
Progression-Free Survival (PFS) at the End of Study
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
Overall Survival (OS)
OS defined as the time from randomization to the date of death due to any cause.
Time frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Overall Response Rate (ORR)
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.
Time frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Disease Control Rate (DCR)
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.
Time frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Time to Progression (TTP)
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.
Time frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
Number of Participants With Adverse Events (AEs) at the End of the Study
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death.
Time frame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
Overall Survival (OS) at the End of Study
OS defined as the time from randomization to the date of death due to any cause.
Time frame: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
| Milestone | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| Started | 154 | 159 |
| Safety population | 154 | 158 |
| Completed | 1 | 3 |
| Not completed | 153 | 156 |
| Withdrew: Death not related to progressive disease | 5 | 6 |
| Withdrew: Adverse event | 14 | 11 |
| Withdrew: Investigator's decision | 0 | 3 |
| Withdrew: Insufficient therapeutic response | 2 | 0 |
| Withdrew: Refused treatment | 1 | 4 |
| Withdrew: Withdrew consent | 4 | 4 |
| Withdrew: Discontinued smoking | 3 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Administrative/other | 6 | 6 |
| Withdrew: Progressive disease | 112 | 115 |
| Withdrew: Death related to progressive disease | 4 | 5 |
| Withdrew: Lost to follow-up | 1 | 1 |
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
| weeks | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| Progression-Free Survival (PFS) | 6.86 (6.29 to 12.00) | 7.00 (6.29 to 11.00) |
OS defined as the time from randomization to the date of death due to any cause.
| months | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| Overall Survival (OS) | 6.77 (5.65 to 8.77) | 6.83 (5.39 to 8.48) |
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response). Patients with no tumor assessment after the start of study treatment were to be considered as non-responders. The percentage of participants in each best response category is presented.
| percentage of participants | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| Complete Response | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) |
| Partial Response | 7.1 (3.6 to 12.4) | 2.5 (0.7 to 6.3) |
| Stable Disease | 33.1 (25.8 to 41.1) | 34.0 (26.6 to 41.9) |
| Progressive Disease | 44.8 (36.8 to 53.0) | 45.9 (38.0 to 54.0) |
| Not Evaluable | 14.9 (9.7 to 21.6) | 17.6 (12.0 to 24.4) |
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans. Disease control rates were measured according to RECIST version 1.1 criteria. A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks. Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease. The percentage of participants with Disease Control is presented.
| percentage of participants | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| Disease Control Rate (DCR) | 40.3 (32.4 to 48.5) | 36.5 (29.0 to 44.5) |
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression. Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.
| weeks | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| Time to Progression (TTP) | 9.86 (6.43 to 12.14) | 9.14 (6.43 to 12.00) |
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death.
| participants | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| Adverse Events (AEs) | 130 | 141 |
| Serious Adverse Events | 29 | 35 |
| AEs leading to withdrawal | 18 | 15 |
| AEs leading to death | 12 | 13 |
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death. For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
| weeks | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| Progression-Free Survival (PFS) at the End of Study | 6.86 (6.29 to 12.00) | 7.00 (6.29 to 11.43) |
OS defined as the time from randomization to the date of death due to any cause.
| months | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| Overall Survival (OS) at the End of Study | 7.00 (5.65 to 8.84) | 6.90 (5.62 to 8.64) |
Collected over Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erlotinib 150 mg | — | 29/154 (18.8%) | 115/154 (74.7%) |
| Erlotinib 300 mg | — | 35/158 (22.2%) | 128/158 (81%) |
| Event | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| PneumoniaInfections and infestations | 6/154 | 3/158 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/154 | 1/158 |
| Respiratory tract infectionInfections and infestations | 0/154 | 3/158 |
| General physical health deteriorationGeneral disorders | 1/154 | 3/158 |
| Myocardial infarctionCardiac disorders | 1/154 | 3/158 |
| DehydrationMetabolism and nutrition disorders | 2/154 | 1/158 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/154 | 2/158 |
| DiarrhoeaGastrointestinal disorders | 1/154 | 2/158 |
| VomitingGastrointestinal disorders | 0/154 | 2/158 |
| Lung infectionInfections and infestations | 1/154 | 0/158 |
| Event | Erlotinib 150 mg | Erlotinib 300 mg |
|---|---|---|
| RashSkin and subcutaneous tissue disorders | 43/154 | 75/158 |
| DiarrhoeaGastrointestinal disorders | 29/154 | 46/158 |
| Decreased appetiteMetabolism and nutrition disorders | 26/154 | 32/158 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 26/154 | 19/158 |
| FatigueGeneral disorders | 21/154 | 26/158 |
| CoughRespiratory, thoracic and mediastinal disorders | 23/154 | 19/158 |
| NauseaGastrointestinal disorders | 20/154 | 17/158 |
| Dry skinSkin and subcutaneous tissue disorders | 13/154 | 17/158 |
| PruritusSkin and subcutaneous tissue disorders | 8/154 | 16/158 |
| Weight decreasedInvestigations | 7/154 | 15/158 |
Intent-to-treat Population included all randomized participants. 2 participants were excluded from analysis: 1 participant randomized in error and 1 participant with missing source data.
| Age, Continuous(years) | Erlotinib 150 mg | Erlotinib 300 mg | Total |
|---|---|---|---|
| Mean | 59.7 ± 9.25 | 59.2 ± 9.14 | 59.4 ± 9.18 |
| Sex: Female, Male(Participants) | Erlotinib 150 mg | Erlotinib 300 mg | Total |
|---|---|---|---|
| Female | 34 | 35 | 69 |
| Male | 120 | 124 | 244 |
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