An Exploratory Phase 2 Study of Pemetrexed/Cisplatin as Pre-operative Chemotherapy in the Treatment of Stage IIIAN2 Nonsquamous Non-Small Cell Lung Cancer

Eli Lilly and Company1 site in 1 country19 target enrollmentNovember 2010

ConditionsNon Small Cell Lung Cancer

InterventionsPemetrexed Cisplatin Folic Acid Vitamin B12 Dexamethasone

DrugsPemetrexed Cisplatin Folic Acid Vitamin B12 Dexamethasone

Overview

Phase: Phase 2
Intervention: Pemetrexed
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Enrollment: 19
Locations: 1
Primary Endpoint: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

April 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy
•Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)
•Tumor considered potentially resectable
•Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)
•No prior therapy for lung cancer
•Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
•Life expectancy of at least 6 months
•Organs are functioning well (bone marrow reserve, liver, kidney, lung)
•Signed Informed Consent
•Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.

Exclusion Criteria

•Receiving or have received an investigational drug or device within the last 30 days
•Have previously completed or withdrawn from this study or any other study investigating pemetrexed
•Serious concomitant systemic disorder
•Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
•Receiving concurrent administration of any other anticancer therapy
•Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination
•Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids)
•Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day

Arms & Interventions

Pemetrexed + Cisplatin

Intervention: Pemetrexed

Pemetrexed + Cisplatin

Intervention: Cisplatin

Pemetrexed + Cisplatin

Intervention: Folic Acid

Pemetrexed + Cisplatin

Intervention: Vitamin B12

Pemetrexed + Cisplatin

Intervention: Dexamethasone

Outcomes

Primary Outcomes

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

Time Frame: From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size \[\<10 millimeter (mm) short axis\]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.

Secondary Outcomes

Percentage of Participants With No Viable Tumor Cells in Resected Lung Tissue [Pathological Complete Remission (pCR)](At the time of surgery (within 3 to 6 weeks of Day 1 of Cycle 3 [21-day cycles] of chemotherapy))
Percentage of Participants Who Exhibit a Downward Shift in Tumor Extent From Stage IIIAN2 to Stages IIIA, II, I, or Stage 0(From study enrollment until disease progression or recurrence up to completion of 3 cycles (21-day cycles) of chemotherapy)
Overall Survival (OS)(Enrollment until the date of death from any cause up to 64 months)
Progression-Free Survival (PFS)(Enrollment until the first date of objectively determined PD or death up to 64 months)