Trial · NCT01996332
A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT01996332, Phase 2, Completed, Hoffmann-La Roche; results first posted 2014-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT01996332. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01996332
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT01996332
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,805 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- erlotinib [Tarceva]
- First posted
- 2013-11-27
- Last updated
- 2014-07-10
- Results first posted
- 2014-07-10
- Limitations and caveats
- Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Disease Progression or Death by Line of Treatment | Baseline, every 6-8 weeks up to 3 years until disease progression or death | Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first. |
| Secondary | Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Baseline, every 6-8 weeks up to 3 years or until death | Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response \[CR\], partial response \[PR\], or stable disease \[SD\]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions. |
| Secondary | Overall Survival (OS) by Line of Treatment | Baseline, every 6-8 weeks up to 3 years, or until death | Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date \[if death date was unavailable\] minus the date of first dose of study medication plus 1 divided by 30.44). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Disease Progression or Death by Line of Treatment | Baseline, every 6-8 weeks up to 3 years until disease progression or death | ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Baseline, every 6-8 weeks up to 3 years or until death | Response evaluable population: participants with measurable disease and with matching criteria to have a response assessment; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) by Line of Treatment | Baseline, every 6-8 weeks up to 3 years, or until death | ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line | months | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Disease Progression or Death by Line of Treatment | Erlotinib 150 mg/Day | 1st Line | 3.4 | 95% Confidence Interval 2.9 to 4.1 | months |
| Time to Disease Progression or Death by Line of Treatment | Erlotinib 150 mg/Day | Maintenance after 1st Line | 4.7 | 95% Confidence Interval 3.0 to 6.6 | months |
| Time to Disease Progression or Death by Line of Treatment | Erlotinib 150 mg/Day | 2nd Line | 2.7 | 95% Confidence Interval 2.5 to 2.9 | months |
| Time to Disease Progression or Death by Line of Treatment | Erlotinib 150 mg/Day | Maintenance after 2nd Line | 3.9 | 95% Confidence Interval 1.2 to 6.8 | months |
| Time to Disease Progression or Death by Line of Treatment | Erlotinib 150 mg/Day | 3rd or Subsequent Line | 2.4 | 95% Confidence Interval 2.2 to 2.7 | months |
| Time to Disease Progression or Death by Line of Treatment | Erlotinib 150 mg/Day | Maintenance after 3rd Line | 2.8 | 95% Confidence Interval 1.8 to 5.0 | months |
| Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Erlotinib 150 mg/Day | 1st line | 70.32 | 95% Confidence Interval 65.21 to 75.08 | percentage of participants |
| Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Erlotinib 150 mg/Day | Maintenance treatment after 1st line | 70.00 | 95% Confidence Interval 53.47 to 83.44 | percentage of participants |
| Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Erlotinib 150 mg/Day | 2nd line | 58.04 | 95% Confidence Interval 53.39 to 62.60 | percentage of participants |
| Percentage of Participants Achieving Clinical Benefit by Line of Treatment | Erlotinib 150 mg/Day | Maintenance treatment after 2nd line | 73.68 | 95% Confidence Interval 48.80 to 90.85 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erlotinib 150 Milligrams Per Day (mg/Day) | 1,805 | |
| Overall Study | COMPLETED | Erlotinib 150 Milligrams Per Day (mg/Day) | 0 | |
| Overall Study | NOT COMPLETED | Erlotinib 150 Milligrams Per Day (mg/Day) | 1,805 |
Source ClinicalTrials.gov
Adverse events374
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rhinitis | Infections and infestations | Erlotinib 150 mg/Day | 14 | 1,797 | |
| other | Allergic reaction | Immune system disorders | Erlotinib 150 mg/Day | 3 | 1,797 | |
| other | Vasculitis | Vascular disorders | Erlotinib 150 mg/Day | 3 | 1,797 | |
| other | Hearing | Ear and labyrinth disorders | Erlotinib 150 mg/Day | 5 | 1,797 | |
| other | Tinnitus | Ear and labyrinth disorders | Erlotinib 150 mg/Day | 3 | 1,797 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Erlotinib 150 mg/Day | 89 | 1,797 | |
| other | Platelets | Investigations | Erlotinib 150 mg/Day | 8 | 1,797 | |
| other | Neutrophils | Investigations | Erlotinib 150 mg/Day | 7 | 1,797 | |
| other | Leucocytes | Investigations | Erlotinib 150 mg/Day | 4 | 1,797 | |
| other | Lymphopenia | Investigations | Erlotinib 150 mg/Day | 1 | 1,797 |
1 to 10 of 374Source ClinicalTrials.gov
See all 374 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib 150 mg/Day | ||
| Total, other adverse events | Erlotinib 150 mg/Day | 1,695 | 1,797 |
| Total, serious adverse events | Erlotinib 150 mg/Day | 566 | 1,805 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01996332
GET https://conductscience.org/api/trials/v1/NCT01996332/events?page=2