Phase 4
Completed N=114
A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01196078 ↗Enrolled (actual)
114
Serious AEs
29.0%
Results posted
Jul 2015
Primary outcomePrimary: Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR) — 22.81; 8.93 percentage of participants — p=0.0388
Summary
This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR) |
22.81; 8.93 | 0.0388 sig |
| SECONDARY Percentage of Participants Achieving Disease Control |
71.93; 57.14 | 0.1061 |
| SECONDARY Duration of Response Among Participants Who Achieved Either a CR or PR |
10.89; 8.75 | 0.9505 |
| SECONDARY Percentage of Participants With Disease Progression |
63.16; 58.93 | — |
| SECONDARY Time to Disease Progression |
6.66; 3.87 | 0.2314 |
| SECONDARY Overall Survival: Percentage of Participants With an Progressive Disease or Death |
56.14; 48.21 | — |
| SECONDARY Overall Survival: Time to Event |
11.21; 10.36 | 0.9894 |
| SECONDARY Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire |
6.8; 6.2; 8.1; 7.5; 8.9; 5.7 | — |
| SECONDARY Changes in Quality of Life as Measured by the FACT Questionnaire |
6.5; 6.0; 10.8; 7.8; 4.3; 1.8 | 0.0060 sig |
| SECONDARY Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change |
7.8; 22.2; 33.3; 31.1; 58.8; 46.7 | — |
| SECONDARY Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire |
1.4; 1.4; 1.6; 1.3; 0.2; -0.1 | — |
| SECONDARY Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change |
17.3; 18.8; 51.9; 58.3; 30.8; 22.9 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >=70 years of age
- Non-small cell lung cancer
- Naive to prior chemotherapy or specific immunotherapy
- Presence of at least 1 measurable lesion
Exclusion Criteria
- Active non-controlled infection or disease
- CNS metastases
- Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)
Data sourced from ClinicalTrials.gov (NCT01196078). 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.