Phase 4
Completed N=6,586
An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT00949910 ↗Enrolled (actual)
6,586
Serious AEs
45.3%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) — 11 percentage of participants
◆ Published Evidence
Established
34citations · ~2 / year
Second-line erlotinib in patients with advanced non-small-cell lung cancer: subgroup analyses from the TRUST study.
Summary
This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.
Linked Publications (2)
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Second-line erlotinib in patients with advanced non-small-cell lung cancer: subgroup analyses from the TRUST study.
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Efficacy of erlotinib in previously treated patients with advanced non-small cell lung cancer: analysis of the Chinese subpopulation in the TRUST study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) |
11 | — |
| SECONDARY Percentage of Participants With Disease Control According to RECIST |
56 | — |
| SECONDARY Percentage of Participants by Best Overall Response According to RECIST |
0.7; 10; 45; 23; 3; 18 | — |
| SECONDARY Percentage of Participants With Death or Disease Progression According to RECIST |
93 | — |
| SECONDARY Progression-Free Survival (PFS) According to RECIST |
3.3 | — |
| SECONDARY Percentage of Participants Who Died |
81 | — |
| SECONDARY Overall Survival (OS) |
7.9 | — |
Eligibility Criteria
Inclusion Criteria
- Adults greater than or equal to (≥) 18 years of age
- Histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC
- Previous treatment with no more than 2 prior chemotherapy regimens
Exclusion Criteria
- Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitors
- Inability to take oral medication
- Any other malignancies within 5 years
Data sourced from ClinicalTrials.gov (NCT00949910) and the linked publication. 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.