Phase 2
Completed N=160
Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer
Source: ClinicalTrials.gov NCT00530621 ↗Enrolled (actual)
160
Serious AEs
39.6%
Results posted
Jul 2020
Primary outcomePrimary: Progression-Free Survival (PFS) — 2.96; 3.02 months — p=0.544
Summary
The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
2.96; 3.02 | 0.544 |
| SECONDARY Overall Survival (OS) |
9.63; 7.39 | 0.171 |
| SECONDARY Time-to-Worsening (TW) in Lung Cancer Symptom Scale (LCSS) - Health Related Quality of Life (HRQoL) Subscale |
3.06; 8.08 | 0.010 sig |
| SECONDARY Duration of Disease Control (DDC) |
5.32; 6.31 | 0.194 |
| SECONDARY Percentage of Participants With Complete Response or Partial Response (Tumor Response Rate) |
3.9; 2.6 | 0.681 |
| SECONDARY Tumor Biomarkers |
55.96; 24.50; 41.98; 9.96; 18.25; 13.64 | — |
Eligibility Criteria
Inclusion Criteria
- Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease which cannot be cured.
- Participants must have disease which progressed after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease.
- At least 1 measurable lesion.
- Must have stopped all previous systemic therapies for cancer for at least 2 weeks prior to enrollment.
- Must be able to follow study guidelines and be able to show up for appointments.
Exclusion Criteria
- Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Previous treatment with enzastaurin or pemetrexed.
- Concurrent administration of any other antitumor therapy.
- Inability to swallow tablets.
- Pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT00530621). 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.