Phase 3
Completed N=424
A Study of Tarceva (Erlotinib) and Standard of Care Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT00556322 ↗Enrolled (actual)
424
Serious AEs
12.5%
Results posted
Feb 2015
Primary outcomePrimary: Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010) — 81.0; 77.8 percentage of participants
Summary
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Died (All Participants; Data Cutoff: 07 September 2010) |
81.0; 77.8 | — |
| PRIMARY Duration of Overall Survival in All Participants (Data Cutoff 07 September 2010) |
5.5; 5.3 | 0.7299 |
| PRIMARY Probable Percentage of Participants Remaining Alive at 1 Year |
24.0; 26.0 | — |
| SECONDARY Percentage of Participants Who Died in Epidermal Growth Factor Receptor (EGFR) Positive and Negative Population |
79.9; 76.9; 79.5; 75.0 | — |
| SECONDARY Duration of OS in EGFR Positive and Negative Population |
5.5; 5.6; 6.7; 5.4 | 0.6198 |
| SECONDARY Probable Percentage of Participants Remaining Alive at 1 Year in the EGFR Positive and Negative Population |
27.0; 30.0; 28.0; 20.0 | — |
| SECONDARY Percentage of Participants With Disease Progression or Death (All Participants; Data Cut Off 07 September 2010) |
83.3; 92.6 | — |
| SECONDARY Progression-Free Survival (PFS) in All Participants (Data Cutoff 07 September 2010) |
8.6; 6.3 | 0.0885 |
| SECONDARY Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months |
17.0; 13.0 | — |
| SECONDARY Percentage of Participants With Disease Progression or Death in EGFR Positive and Negative Population (Data Cut Off 07 September 2010) |
79.9; 93.7; 89.7; 90.6 | — |
| SECONDARY PFS in EGFR Positive and Negative Population (Data Cutoff 07 September 2010) |
8.9; 6.3; 11.5; 6.7 | 0.0662 |
| SECONDARY Probable Percentage of Participants Remaining Alive and Progression Free at 6 Months in EGFR Positive and Negative Population |
20.0; 13.0; 11.0; 16.0 | — |
| SECONDARY Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator Using RECIST |
6.3; 7.9 | 0.5349 |
| SECONDARY Percentage of Participants With Deterioration in Quality of Life Determined Using Functional Assessment of Cancer Therapy - Lung (FACT-L) |
66.1; 66.9 | — |
| SECONDARY Time to Deterioration in Quality of Life Using FACT-L |
9.0; 6.3 | 0.1498 |
| SECONDARY Probable Percentage of Participants Remaining Without Deterioration in Quality of Life at 6 Months as Assessed by FACT-L |
25.0; 19.0 | — |
| SECONDARY Percentage of Participants With Symptomatic Progression Using FACT-L |
60.6; 62.0 | — |
| SECONDARY Time to Symptomatic Progression Using FACT-L |
9.0; 7.1 | 0.2202 |
| SECONDARY Probable Percentage of Participants With Symptomatic Progression at 6 Months as Assessed by FACT-L |
27; 27 | — |
| SECONDARY Percentage of Participants With Deterioration in the Trial Outcome Index (TOI) |
60.0; 63.3 | — |
| SECONDARY Time to Deterioration in the TOI |
9.3; 6.7 | 0.1063 |
| SECONDARY Probable Percentage of Participants With Deterioration in the TOI at 6 Months as Assessed by FACT-L |
28; 21 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- histologically documented, locally advanced or recurrent or metastatic NSCLC;
- measurable disease;
- disease progression during 1-4 cycles of platinum-based chemotherapy.
Exclusion Criteria
- any other malignancies within the last 5 years;
- unstable systemic disease.
Data sourced from ClinicalTrials.gov (NCT00556322). 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.