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

Eli Lilly and Company122 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Non-Small Cell Lung Cancer

Interventions

pemetrexedDRUG

500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 4 cycles

cisplatinDRUG

75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles

carboplatinDRUG

area under the curve (AUC) 5 milligrams per milliliter\*minute (mg/ml\*min), intravenous (IV), every 21 days x 4 cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Outcomes

Primary Outcomes

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.

Time frame: every 21-day cycle for 4 cycles up to 30 days after last infusion

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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.

Bordeaux, France

Paris, France

Rennes, France

Saint-Priest-en-Jarez, France

Toulouse, France

Bad Berka, Germany

Bielefeld, Germany

Cologne, Germany

Großhansdorf, Germany

Halle, Germany

...and 8 more locations