Phase 3
Completed N=236
A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01017874 ↗Enrolled (actual)
236
Serious AEs
28.9%
Results posted
Apr 2014
Primary outcomePrimary: Progression Free Survival (PFS) — 8.38; 9.63 months — p=0.217
Summary
The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
8.38; 9.63 | 0.217 |
| SECONDARY Overall Survival (OS) |
26.87; 27.86 | 0.788 |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)] |
41.5; 47.5 | — |
| SECONDARY Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)] |
71.2; 64.4 | — |
| SECONDARY Time to Progressive Disease (TtPD) |
8.61; 9.69 | 0.252 |
| SECONDARY Duration of Tumor Response |
12.09; 11.93 | 0.952 |
| SECONDARY Time to Worsening of Health-Related Quality of Life (TWQ) Using the Participant-Rated Lung Cancer Symptom Scale (LCSS) |
2.99; 7.95; 4.83; 7.29; 8.57; 16.69 | — |
Eligibility Criteria
Inclusion Criteria
- Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of non-squamous histology.
- Participants must be "light ex-smokers" or "never-smokers".
- "Light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years.
- "Never-smokers" are defined as having smoked <100 cigarettes or equivalent during his/her lifetime.
- Participants must be of East Asian ethnicity.
- No prior systemic therapy for lung cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
- Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- Any evidence of clinically active interstitial lung disease. Asymptomatic participants with chronic, stable, radiographic changes are eligible.
- Participants whose Epidermal Growth Factor Receptor (EGFR) mutation status is known prior to study entry will be excluded. Participants in which EGFR mutation testing has not been performed, or whose EGFR mutation status is unknown or inconclusive at study entry are eligible.
Data sourced from ClinicalTrials.gov (NCT01017874). 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.