Phase 2
N=218
First Line Chemotherapy Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00308750 ↗Enrolled (actual)
218
Serious AEs
38.8%
Results posted
May 2021
Primary outcome: Primary: Time to Disease Progression — 4.6; 6.0; 4.1 months — p=0.40
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- enzastaurin (Drug); pemetrexed (Drug); docetaxel (Drug); carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Disease Progression |
4.6; 6.0; 4.1 | 0.40 |
| SECONDARY Tumor Biomarkers Associated With Clinical Outcomes |
— | — |
| SECONDARY Assessment of Smoking History (All Participants) and Hormone Replacement Therapy (Female Participants Only) Associated With Clinical Outcomes |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) or Deaths |
63; 70; 69; 35; 20; 26 | — |
| SECONDARY Change From Baseline in Total Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale |
-3.98; 1.12; -3.33; -3.25; -1.54; -2.16 | 0.96 |
| SECONDARY Change From Baseline in Total Functional Assessment of Cancer Therapy -Taxane (FACT-Taxane) Scale |
-3.16; -0.78; -2.17; -6.22; -5.66; -3.13 | 0.93 |
| SECONDARY Overall Survival (OS) |
7.2; 12.7; 9.2 | 0.87 |
| SECONDARY Number of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response] |
9; 16; 19 | — |
| SECONDARY Duration of CR or PR (Duration of Response) |
7.4; 9.3; 5.8 | — |
| SECONDARY Time-to-Treatment Failure (TTF) |
2.6; 3.8; 2.6 | 0.71 |
Summary
The purposes of this study are to determine:
The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or docetaxel with carboplatin and any side effects that might be associated with the combination of these drugs.
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can help participants with non-small cell lung cancer (NSCLC) live longer, compared with the combination of docetaxel and carboplatin.
Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can make your tumor smaller or disappear, and for how long, compared with the combination of docetaxel and carboplatin.
The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or docetaxel with carboplatin have on your disease related symptoms.
The relation of smoking history and hormone replacement therapy (for women only) may have to your lung cancer treatment results.
The effects of certain genes and proteins in samples of your blood and tumor tissue in order to learn more about NSCLC and how enzastaurin works in the body.
Eligibility Criteria
Inclusion Criteria
- You must have been diagnosed with NSCLC.
- You must be able to visit the doctor's office weekly during the active treatment period and as needed during the study follow-up period.
- You must be willing and able to swallow capsules.
- Your entry labs and medical tests must meet study requirements.
- You must be willing to have blood samples drawn and tissue samples obtained for gene and protein testing.
Exclusion Criteria
- You have received radiation within 2 weeks of study enrollment.
- You have previously received any anti-cancer drug therapy for NSCLC.
- You have an active infection or other serious condition.
- You take aspirin or aspirin-like medication regularly and are not able to stop taking them for a few days during each cycle of chemotherapy.
- You have recently lost a significant amount of weight.
Data sourced from ClinicalTrials.gov (NCT00308750). 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.