N/A
Completed N=465
An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01535729 ↗Enrolled (actual)
465
Serious AEs
20.5%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants Who Were Alive 1 Year After Start of Treatment — 30.6; 26.6; 29.8; 37.2 percentage of participants
Summary
This prospective observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in elderly patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Data of patients treated with Tarceva in routine clinical practice will be collected for 1 year.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Were Alive 1 Year After Start of Treatment |
30.6; 26.6; 29.8; 37.2; 25.6 | — |
| SECONDARY Median Overall Survival: Age |
7.039; 6.612; 7.928; 6.020 | 0.756 |
| SECONDARY Percentage of Participants With Fatigue |
89.1; 38.7; 19.5; 13.8 | — |
| SECONDARY Percentage of Participants With Rash |
90.6; 37.9; 19.5; 13.8 | — |
| SECONDARY Percentage of Participants With Diarrhea |
89.6; 39.0; 19.5; 13.8 | — |
| SECONDARY Percentage of Participants With Rash Based on Severity During the Course of Time |
19.2; 23.1; 4.4; 8.1; 5.7; 1.0 | — |
| SECONDARY Percentage of Participants With Diarrhea Based on Severity During the Course of Time |
11.9; 7.3; 0.3; 0.3; 2.3; 0.8 | — |
| SECONDARY Percentage of Participants With Fatigue Based on Severity During the Course of Time |
6.8; 8.1; 0.3; 1.8; 1.8; 0.3 | — |
| SECONDARY Percentage of Participants With Dose Modifications by Reason |
1.0; 0.8; 0.3; 0.3; 0.3; 0.3 | — |
| SECONDARY Percentage of Participants With Dose Withdrawals by Reason |
34.3; 2.9; 3.4; 8.3; 1.0; 12.7 | — |
| SECONDARY Percentage of Participants With Cough by Severity |
13.8; 24.9; 2.9; 1.6; 15.1; 14.5 | — |
| SECONDARY Percentage of Participants With Dyspnea by Severity |
16.1; 20.3; 8.1; 1.3; 10.1; 17.4 | — |
| SECONDARY Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD) |
0.8; 4.9; 25.2; 0.5; 3.1; 14.3 | — |
| SECONDARY Time to Start of Erlotinib Therapy After End of First Line Therapy |
2.30 | — |
| SECONDARY Percentage of Participants With Remission of CR and PR |
5.7; 3.6; 1.8; 2.1 | — |
| SECONDARY Median Progression Free Survival: Overall |
3.5 | — |
| SECONDARY Median Progression Free Survival: Age |
3.257; 3.388; 5.033; 2.928 | 0.895 |
| SECONDARY Median Progression Free Survival: Gender |
3.355; 4.046 | 0.015 sig |
| SECONDARY Median Progression Free Survival: Smoking Status |
3.454; 5.526; 2.993 | 0.000 sig |
| SECONDARY Median Progression Free Survival: Best Response to Prior Chemotherapy |
— | — |
| SECONDARY Median Overall Survival: Overall |
7.1 | — |
| SECONDARY Median Overall Survival: Gender |
6.283; 8.125 | 0.027 sig |
| SECONDARY Median Overall Survival: Smoking Status |
6.612; 11.184; 5.855 | 0.000 sig |
| SECONDARY Median Overall Survival: Best Response to Prior Chemotherapy |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, > 65 years of age
- Locally advanced or metastatic non-small cell lung cancer (Stage IIIb or IV)
- Failure of at least one prior standard platinum-based chemotherapy
Exclusion Criteria
- Age < 65 years
Data sourced from ClinicalTrials.gov (NCT01535729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.