Study for Participants With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo

Lilly

Status and phase: Terminated; Phase 2

Conditions: Lung Cancer

Treatments: Drug: pemetrexed; Drug: enzastaurin; Drug: placebo; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00538681

H6Q-MC-S021 (Other Identifier)

10722

Details and patient eligibility

About

This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts:

• Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy
• Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin + enzastaurin versus pemetrexed + cisplatin + placebo. Participants to be included in Part 2 are those with Nonsquamous Non-Small Cell Lung Cancer (NSCLC).

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of advanced NSCLC not amenable to curative treatment. Participants enrolling in Part 2 of the study must have the above stated diagnosis of NSCLC that is also of nonsquamous histology.
• no prior systemic therapies [chemotherapy, et cetera (etc.)] or pleurodesis with chemotherapy for this disease
• prior radiotherapy is allowed but must be completed at least 2 weeks before study enrollment and participant must be recovered from the acute toxic effects
• have a good performance status
• participant must sign an informed consent document

Exclusion criteria

• participant had myocardial infarction occurring less than 6 months before inclusion, uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not controlled by medications
• participant is unable to swallow tablets
• participant is taking a certain medicine to control seizure activity, called "enzyme inducing antiepileptic drugs" and is not able to stop taking the medicine prior to enrolling in the study
• participant is unable to interrupt aspirin and/or other anti-inflammatory agents
• participant is unwilling or unable to take vitamin supplementation (folic acid and vitamin B12) or medications to prevent side effects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 2 patient groups, including a placebo group

Enzastaurin + Pemetrexed + Cisplatin

Experimental group

Treatment:

Drug: cisplatin

Drug: enzastaurin

Drug: pemetrexed

Placebo + Pemetrexed + Cisplatin

Placebo Comparator group

Treatment:

Drug: cisplatin

Drug: placebo

Drug: pemetrexed