Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC). A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

Official Title
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A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer

Conditions
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Non-Small Cell Lung Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven non-small cell lung cancer stage Ib, IIa or IIb Must have complete tumor resection by pneumonectomy or lobectomy Must have been surgically proven to be N2 negative Exclusion Criteria: Serious concomitant systemic disorder Post-operative complications or other surgery related conditions A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago

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: Pemetrexed + Cisplatin<br> | Drug: pemetrexed<br>* 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles<br>* Other names: Alimta;Drug: cisplatin<br>* 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles<br>|
| Experimental: B: Pemetrexed + Carboplatin<br> | Drug: pemetrexed<br>* 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles<br>* Other names: Alimta;Drug: carboplatin<br>* area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Feasibility of Post-Surgery Chemotherapy | Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion. | every 21-day cycle for 4 cycles up to 30 days after last infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade III/IV Adverse Events | Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study. | every 21-day cycle for 4 cycles | 
| Overall Survival at 3 Years | For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date. | baseline to date of death from any cause, assessed at 3 years | 
| 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years | For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years. | length of time disease free, assessed at 3 years | 
| Overall Survival at 6 Years | For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date. | Baseline to date of death from any cause assessed at 6 years |