Phase 2
Completed N=204
Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
Source: ClinicalTrials.gov NCT00447057 ↗
Enrolled (actual)
204
Serious AEs
47.1%
Results posted
Oct 2011
Primary outcomePrimary: Progression Free Survival (PFS) — 2.9; 3.2 months — p=0.0047
Summary
This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival [PFS], disease control rate, best response rate, time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
2.9; 3.2 | 0.0047 sig |
| SECONDARY Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate) |
51.8; 55.3 | 0.3909 |
| SECONDARY Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate) |
10.8; 17.1 | 0.1808 |
| SECONDARY Time to Treatment Failure (TTTF) |
2.4; 3.0 | 0.0034 sig |
| SECONDARY Overall Survival (OS) |
7.8; 11.8 | 0.0190 sig |
| SECONDARY Percentage of Participants Surviving at 1 Year |
34.1; 49.4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
43; 53; 91; 98 | — |
Eligibility Criteria
Inclusion Criteria
- Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.
- Failure of previous treatment with one prior platinum-based chemotherapy regimen.
- Good performance status.
- Adequate bone marrow reserve, renal and hepatic functions.
Exclusion Criteria
- Serious concomitant systemic disease.
- Inability to take oral medication.
- Inability or unwillingness to take vitamin supplementation and corticosteroids.
- Pregnancy / Breast-feeding.
- Treatment with certain medicines that prevent blood from clotting.
Data sourced from ClinicalTrials.gov (NCT00447057). 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.