Trial · NCT00949910
An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT00949910, Phase 4, Completed, Hoffmann-La Roche; results first posted 2016-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC). Trials, record NCT00949910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00949910
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
- NCT number
- NCT00949910
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 6,586 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Erlotinib
- First posted
- 2009-07-31
- Last updated
- 2016-10-05
- Other registries' IDs
- eudract:2004-000564-28
- Results first posted
- 2016-10-04
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported. |
| Secondary | Percentage of Participants With Disease Control According to RECIST | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (\<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported. |
| Secondary | Percentage of Participants by Best Overall Response According to RECIST | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but \<20% increase in sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is \<1) with each type of best overall response was reported. |
| Secondary | Percentage of Participants With Death or Disease Progression According to RECIST | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported. |
| Secondary | Progression-Free Survival (PFS) According to RECIST | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months. |
| Secondary | Percentage of Participants Who Died | Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter | The percentage of participants (in nearest integer) who died from any cause was reported. |
| Secondary | Overall Survival (OS) | Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter | OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | ITT/Safety Population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control According to RECIST | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | ITT/Safety Population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants by Best Overall Response According to RECIST | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | ITT/Safety Population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Death or Disease Progression According to RECIST | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | ITT/Safety Population; only participants with available data were included. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) According to RECIST | Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter | ITT/Safety Population; only participants with available data were included. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Died | Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter | ITT/Safety Population. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter | ITT/Safety Population. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) | Erlotinib | 11 | percentage of participants | ||
| Percentage of Participants With Disease Control According to RECIST | Erlotinib | 56 | percentage of participants | ||
| Percentage of Participants by Best Overall Response According to RECIST | Erlotinib | Complete Response (CR) | 0.7 | percentage of participants | |
| Percentage of Participants by Best Overall Response According to RECIST | Erlotinib | Partial Response (PR) | 10 | percentage of participants | |
| Percentage of Participants by Best Overall Response According to RECIST | Erlotinib | Stable Disease (SD) | 45 | percentage of participants | |
| Percentage of Participants by Best Overall Response According to RECIST | Erlotinib | Progressive Disease (PD) | 23 | percentage of participants | |
| Percentage of Participants by Best Overall Response According to RECIST | Erlotinib | Not Evaluable | 3 | percentage of participants | |
| Percentage of Participants by Best Overall Response According to RECIST | Erlotinib | Not Done | 18 | percentage of participants | |
| Percentage of Participants by Best Overall Response According to RECIST | Erlotinib | Not Known | 0.0 | percentage of participants | |
| Percentage of Participants by Best Overall Response According to RECIST | Erlotinib | No Data | 0.3 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 | 6,586 | |
| Overall Study | COMPLETED | Erlotinib | 10 | |
| Overall Study | NOT COMPLETED | Erlotinib | 6,576 |
Source ClinicalTrials.gov
Adverse events521
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 |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Erlotinib | 43 | 6,586 | |
| serious | Anaemia folate deficiency | Blood and lymphatic system disorders | Erlotinib | 1 | 6,586 | |
| serious | Anaemia of malignant disease | Blood and lymphatic system disorders | Erlotinib | 2 | 6,586 | |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Erlotinib | 2 | 6,586 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Erlotinib | 2 | 6,586 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Erlotinib | 1 | 6,586 | |
| serious | Neutropenia | Blood and lymphatic system disorders | Erlotinib | 1 | 6,586 | |
| serious | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Erlotinib | 1 | 6,586 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | Erlotinib | 2 | 6,586 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Erlotinib | 2 | 6,586 |
1 to 10 of 521Source ClinicalTrials.gov
See all 521 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib | ||
| Total, other adverse events | Erlotinib | 0 | 6,586 |
| Total, serious adverse events | Erlotinib | 2,983 | 6,586 |
Source ClinicalTrials.gov
Papers2
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 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/NCT00949910
GET https://conductscience.org/api/trials/v1/NCT00949910/events?page=2