Trial · NCT01652469
Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.
NCT01652469, Phase 3, Completed, ETOP IBCSG Partners Foundation; results first posted 2019-08-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®. Trials, record NCT01652469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01652469
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.
- NCT number
- NCT01652469
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 81 participants, actual
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Erlotinib, Docetaxel
- First posted
- 2012-07-30
- Last updated
- 2026-08-26
- Other registries' IDs
- eudract:2012-001896-35
- Results first posted
- 2019-08-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months. | Time from the date of randomization until documented progression or death without documented progression. Assessment of Progressive Disease (PD) based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) Target lesions: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.(Note: the appearance of one or more new lesions is also considered progression). Non-target lesions:Unequivocal progression of existing non-target lesions. (Note:the appearance of one or more new lesions is also considered progression). To achieve 'unequivocal progression', there must be an overall level of substantial worsening in non-target disease such that,even in presence of SD or PR in target disease, the overall tumour burden has increased sufficiently |
| Secondary | Overall Survival | All patients will be followed for survival status every 12 weeks up to 24 months after the last patient is randomized | Defined as time from the date of randomization until death from any cause. |
| Secondary | Objective Response | Same as primary outcome: 24 months | Objective response is defined as best overall response (CR or PR) across all assessment time-points according to RECIST Criteria 1.1 during the period from randomization to termination of trial treatment. |
| Secondary | Disease Control | Same as primary outcome: 24 months | Disease control is defined as achieving objective response or stable disease for at least 6 weeks. |
| Secondary | Number of Participants With Adverse Events | Same as primary outcome: 24 months | Adverse events classified according to NCI CTCAE version 4 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months. | months | MEDIAN | |
| SECONDARY | Overall Survival | All patients will be followed for survival status every 12 weeks up to 24 months after the last patient is randomized | months | MEDIAN | |
| SECONDARY | Objective Response | Same as primary outcome: 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Control | Same as primary outcome: 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events | Same as primary outcome: 24 months | One patient from the Docetaxel arm never started treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | A: Erlotinib | 1.6 | 95% Confidence Interval 1.3 to 3.8 | months | |
| Progression-free Survival | B: Docetaxel | 3.0 | 95% Confidence Interval 1.9 to 4.2 | months | |
| Overall Survival | A: Erlotinib | 7.1 | 95% Confidence Interval 4.4 to 10.6 | months | |
| Overall Survival | B: Docetaxel | 7.1 | 95% Confidence Interval 5.3 to 8.6 | months | |
| Objective Response | A: Erlotinib | Partial response | 4 | Participants | |
| Objective Response | B: Docetaxel | Partial response | 6 | Participants | |
| Objective Response | A: Erlotinib | Stable Disease | 15 | Participants | |
| Objective Response | B: Docetaxel | Stable Disease | 18 | Participants | |
| Objective Response | A: Erlotinib | Progressive Disease | 17 | Participants | |
| Objective Response | B: Docetaxel | Progressive Disease | 14 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A: Erlotinib | 38 | |
| Overall Study | STARTED | B: Docetaxel | 42 | |
| Overall Study | COMPLETED | A: Erlotinib | 37 | |
| Overall Study | COMPLETED | B: Docetaxel | 36 | |
| Overall Study | NOT COMPLETED | A: Erlotinib | 1 | |
| Overall Study | NOT COMPLETED | B: Docetaxel | 6 |
Source ClinicalTrials.gov
Adverse events116
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 | Fatigue | General disorders | A: Erlotinib | 11 | 38 | |
| other | Fatigue | General disorders | B: Docetaxel | 24 | 41 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | A: Erlotinib | 16 | 38 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | B: Docetaxel | 13 | 41 | |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | A: Erlotinib | 27 | 38 | |
| other | Rash maculo-papular | Skin and subcutaneous tissue disorders | B: Docetaxel | 1 | 41 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | A: Erlotinib | 10 | 38 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | B: Docetaxel | 14 | 41 | |
| other | Diarrhea | Gastrointestinal disorders | A: Erlotinib | 10 | 38 | |
| other | Diarrhea | Gastrointestinal disorders | B: Docetaxel | 11 | 41 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: Erlotinib | 7 | 38 |
| Total, all-cause mortality | B: Docetaxel | 3 | 41 |
| Total, other adverse events | A: Erlotinib | 36 | 38 |
| Total, other adverse events | B: Docetaxel | 39 | 41 |
| Total, serious adverse events | A: Erlotinib | 7 | 38 |
| Total, serious adverse events | B: Docetaxel | 19 | 41 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A: Erlotinib vs B: Docetaxel: deaths from any cause | Trial comparisons |
| A: Erlotinib vs B: Docetaxel: serious adverse events | Trial comparisons |
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/NCT01652469
GET https://conductscience.org/api/trials/v1/NCT01652469/results?page=2