Phase 2
Completed N=1,805
A Study of Tarceva (Erlotinib) Monotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov NCT01996332 ↗Enrolled (actual)
1,805
Serious AEs
31.4%
Results posted
Jul 2014
Primary outcomePrimary: Time to Disease Progression or Death by Line of Treatment — 3.4; 4.7; 2.7; 3.9 months
Summary
This study will evaluate the efficacy and safety of oral Tarceva in patients with advanced NSCLC for whom Tarceva monotherapy is considered the best therapeutic option. The anticipated time on study treatment is 3-12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Disease Progression or Death by Line of Treatment |
3.4; 4.7; 2.7; 3.9; 2.4; 2.8 | — |
| SECONDARY Percentage of Participants Achieving Clinical Benefit by Line of Treatment |
70.32; 70.00; 58.04; 73.68; 52.71; 50.00 | — |
| SECONDARY Overall Survival (OS) by Line of Treatment |
6.4; 12.1; 5.9; 7.1; 5.2; 3.9 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- locally advanced or metastatic NSCLC (Stage IIIB or IV);
- not a candidate for curative surgery or radical chemotherapy;
- no brain metastases, or clinically stable metastases for >=2 months.
Exclusion Criteria
- radiotherapy over the previous 2 weeks;
- weight loss >10% in the previous 6 weeks.
Data sourced from ClinicalTrials.gov (NCT01996332). 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.