Phase 2
Completed N=188
A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
Source: ClinicalTrials.gov NCT00769067 ↗Enrolled (actual)
188
Serious AEs
34.2%
Results posted
Aug 2015
Primary outcomePrimary: Progression-Free Survival (PFS) — 8.3; 12.4 weeks — p=0.012
Summary
This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
8.3; 12.4 | 0.012 sig |
| SECONDARY Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) |
14; 11; 36; 34; 35; 40 | — |
| SECONDARY Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) |
18; 24; 29; 20; 38; 43 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) |
0.70; 0.88; 4.35; 3.06; 5.16; 3.91 | — |
| SECONDARY Percentage of Participants With Objective Response |
5.3; 17.0 | 0.011 sig |
| SECONDARY Best Overall Response (BOR) |
0; 1; 5; 15; 37; 32 | — |
| SECONDARY Duration of Response (DR) |
40.1; 71.9 | — |
| SECONDARY Overall Survival (OS) |
32.3; 41.4 | 0.252 |
Eligibility Criteria
Inclusion Criteria
- advanced measurable Non-Small Cell Lung Cancer (NSCLC);
- progressed after 1-2 prior chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) 0-2;
- tissue available for future KRAS/ EGFR testing
Exclusion Criteria
- prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
- active or untreated Central Nervous System (CNS) metastases;
Data sourced from ClinicalTrials.gov (NCT00769067). 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.