Phase 2
N=688
A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.
Non-Squamous Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01250119 ↗Enrolled (actual)
688
Serious AEs
39.0%
Results posted
Oct 2015
Primary outcome: Primary: Percentage of Participants Who Tested Positive for EGFR Mutations — 8.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- erlotinib [Tarceva] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Tested Positive for EGFR Mutations |
8.1 | — |
| PRIMARY Percentage of Participants With EGFR Mutations by Subgroup |
0.0; 22.6; 100.0; 67.3; 0; 1.7 | 0.0000 sig |
| SECONDARY Percentage of Participants With a Response by Best Objective Tumor Response |
0.0; 84.8; 9.1; 6.1 | — |
| SECONDARY Probability of Being Alive and Free of Progression by Timepoint |
1.00; 0.97; 0.94; 0.73; 0.54; 0.37 | — |
| SECONDARY Survival Time in Months |
12.57 | — |
| SECONDARY Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument |
62.6; 65.4; 63.0; -0.4 | — |
| SECONDARY Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D |
43.9; 56.1; 0.0; 45.0; 55.0; 0.0 | — |
| SECONDARY Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D |
78.0; 17.1; 4.9; 80.0; 20.0; 0.0 | — |
| SECONDARY Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D |
39.0; 46.3; 14.6; 40.0; 50.0; 10.0 | — |
| SECONDARY Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D |
29.3; 63.4; 7.3; 10.0; 85.0; 5.0 | — |
| SECONDARY Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D |
52.5; 37.5; 10.0; 57.9; 42.1; 0.0 | — |
Summary
This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Locally advanced or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC)
- ECOG performance status 0-3
- Treatment phase: histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study
- Adequate haematological, liver and renal function
- Female patients must be postmenopausal, surgically sterile, or agree to use a barrier method of contraception
- Male patients must be surgically sterile or agree to use a barrier method of contraception
Exclusion Criteria
- Previous treatment for NSCLC with chemotherapy or therapy against EGFR, either with antibody or small molecule (tyrosine kinase inhibitor)
- Symptomatic cerebral metastases
- Pregnant or lactating women
- Any other concomitant anti-cancer therapy (until disease progression and discontinuation of Tarceva therapy)
Data sourced from ClinicalTrials.gov (NCT01250119). 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.