Spots Global Cancer Trial Database for A Study of Pemetrexed and Cisplatin, in Non Small Cell Lung Cancer

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Trial Identification

Brief Title: A Study of Pemetrexed and Cisplatin, in Non Small Cell Lung Cancer

Official Title: Phase 2 Study of Pemetrexed and Cisplatin as Induction, Followed by Pemetrexed and Cisplatin With Concurrent Thoracic Radiotherapy, in Patients With Unresectable, Locally Advanced, Stage III, Nonsquamous Non-Small Cell Lung Cancer

Study ID: NCT01000480

Conditions

Non Small Cell Lung Cancer

Interventions

Pemetrexed

Cisplatin

Thoracic Radiotherapy

Study Description

Brief Summary: This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in combination with radiotherapy in participants with locally advanced, non-small cell lung cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by progression free survival 1 year after start of treatment with study drug.

Detailed Description: The participants will receive 2 cycles of pemetrexed and cisplatin. If the participants achieve complete response, partial response or stable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, have ≤35% of the total calculated lung volume receive more than 20 Gy (V20) according to the 3-dimensional (3-D) radiotherapy planning Dose Volume Histograms, have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, have no residual neurological toxicity \> Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), they will receive 2 additional cycles of pemetrexed and cisplatin, combined with radiotherapy. The combination of radiotherapy will begin 22 to 36 days after completion of the second infusion of induction therapy with pemetrexed-cisplatin.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Le Mans, , France

Contact Details

Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT- 5 hours, EST)

Affiliation: Eli Lilly and Company

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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