Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Official Title
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A Randomized Phase 3 Study Comparing Pemetrexed-Carboplatin With Docetaxel-Carboplatin as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior chemotherapy for advanced disease or molecular target treatment Easter Cooperative Oncology Group (ECOG) performance status 0 to 2 Estimated life expectancy of at least 8 weeks Exclusion Criteria: Known or suspected brain metastases Concurrent administration of any other tumor therapy Serious concomitant disorders Pregnancy or breast feeding Inability or unwillingness to take folic acid or vitamin B12 supplementation

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: pemetrexed plus carboplatin<br>Drug: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous (IV), every (q) 21 days x 6 cycles maximum Drug: carboplatin Area Under the Curve (AUC) 5 milligram*minute/milliLiter (mg*min/mL), IV, q 21 days x 6 cycles maximum | Drug: pemetrexed<br>* 500 mg/m^2, IV, q 21 days x 6 cycles maximum<br>* Other names: Alimta;Drug: carboplatin<br>* AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum<br>|
| Active Comparator: docetaxel plus carboplatin<br>Drug: docetaxel 75 mg/m^2, IV, q 21 days x 6 cycles maximum Drug: carboplatin AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum | Drug: docetaxel<br>* 75 mg/m^2, IV, q 21 days x 6 cycles maximum<br>Drug: carboplatin<br>* AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Without Grade 3 or 4 Toxicity | Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact. | Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact. | Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). | 
| Progression-free Survival (PFS) | Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause. | Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). | 
| Percentage of Participants With Tumor Response (Response Rate) | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100. | Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). | 
| Survival Without Clinically Important Grade 3 or 4 Toxicity | Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact. | Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). | 
| Survival Without Grade 4 Toxicity | Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact. | Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months). | 
| Number of Participants With Adverse Events (AEs) | Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module. | Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months). |