Phase 2
Completed N=74
A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
Source: ClinicalTrials.gov NCT01204697 ↗Enrolled (actual)
74
Serious AEs
34.3%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Participants Free From Disease Progression or Death at 6 Months — 8.3; 8.1 percentage of participants
Summary
This randomized parallel group study will assess the efficacy and safety of erlotinib [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Free From Disease Progression or Death at 6 Months |
8.3; 8.1 | — |
| SECONDARY Progression-free Survival (PFS) |
2.33; 2.82 | — |
| SECONDARY Overall Survival (OS) |
5.61; 8.95 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) |
2.8; 8.1 | — |
| SECONDARY Percentage of Participants With Disease Control |
41.7; 37.8 | — |
| SECONDARY Duration of Response (DoR) |
NA; 8.69 | — |
Eligibility Criteria
Inclusion Criteria
- male patients, >/=18 years of age
- former smoker (smoked >/= 100 cigarettes in his lifetime and quit >12 months before enrollment)
- locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small cell lung cancer
- prior platinum-based therapy for advanced NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria
- uncontrolled symptomatic central nervous system (CNS) metastases
- prior therapy against epidermal growth factor receptor (EGFR)
- >1 prior chemotherapy for advanced/metastatic NSCLC
- radiotherapy 5 years
- not fully treated eye inflammation or infection, or predisposing conditions
Data sourced from ClinicalTrials.gov (NCT01204697). 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.