Clinical trial · Interventional
Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer
A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
NCT00530621CI-TRIAL-00045753completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzastaurin | Drug | Enzastaurin | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pemetrexed + Enzastaurin
- interventionNames
- Drug: enzastaurin
- Drug: pemetrexed
- type
- PLACEBO_COMPARATOR
- label
- Pemetrexed + Placebo
- interventionNames
- Drug: placebo
- Drug: pemetrexed
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Baseline to measured progressive disease up to 9.92 months
- description
- PFS was defined as the time from date of randomization to the first documented observation of disease progression or death from any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death at the data inclusion cut-off date.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.