Phase 2
N=23
A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations
Carcinoma，Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT01153984 ↗Enrolled (actual)
23
Serious AEs
21.7%
Results posted
Apr 2017
Primary outcome: Primary: Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) — 387.000 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erlotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
387.000 | — |
| SECONDARY Time to Disease Progression, as Assessed by Investigator Using RECIST v1.1 |
193.00 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) And Partial Response (PR) as Assessed by the Investigator Using RECIST v1.1 |
0; 8.7 | — |
| SECONDARY Percentage of Participants Who Were Alive One Year After Study Treatment Initiation |
85.7 | — |
| SECONDARY Percentage of Participants by Localization of PD, as Assessed by Investigator Using RECIST v1.1 |
24; 14; 10; 14; 38 | — |
| SECONDARY Number of EGFR Positive Participants Classified Based on Smoking Status |
17; 3; 3 | — |
| SECONDARY Number of EGFR Positive Participants Classified Based on Type of EGFR Mutations |
20; 3 | — |
| SECONDARY Percentage of Similar EGFR Mutations Between Matched Plasma and Tumor Tissue Samples |
— | — |
Summary
This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
Eligibility Criteria
Inclusion Criteria
- Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
- Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy greater than or equal to (≥) 12 weeks
- Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
- Adequate hematological , liver and renal function
Exclusion Criteria
- Known hypersensitivity to erlotinib or any of its excipients
- Squamous non-small cell or small cell tumors or absence of histological report
- Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
- Prior exposure to inhibitors of EGFR
- Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
- Radical radiotherapy with curative intent within 28 days prior to enrollment
- Any active non-controlled systemic disease
Data sourced from ClinicalTrials.gov (NCT01153984). 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.