Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.

Official Title
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A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: pemetrexed
* Drug: etoposide
* Drug: carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of extensive stage small cell lung cancer (SCLC) Capable of self-care but may be unable to carry out any work activities. No prior anticancer therapy for SCLC Exclusion Criteria: have previously participated in a study involving pemetrexed have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: pemetrexed<br>* 500 mg/m2, intravenous (IV), every 21 days x 6 cycles<br>* Other names: Alimta;Drug: carboplatin<br>* Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles<br>|
| Active Comparator: B<br> | Drug: etoposide<br>* 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles<br>Drug: carboplatin<br>* Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | baseline to date of death from any cause (up to 19.6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (Subgroups) | The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure. | baseline to date of death from any cause (up to 19.6 months) | 
| Progression Free Survival | The period from study entry until disease progression, death or date of last contact. | baseline to measured progressive disease (up to 14.7 months) | 
| Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L) | FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points. | baseline and 6 cycles (21-day cycles) | 
| Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes) | The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure. | baseline to date of death due to any cause (up to 19.6 months) |