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NCT Number: NCT00269152

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

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

Other names: LY231514, Alimta

Cisplatin

Drug

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

carboplatin

Drug

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

Primary outcomes

  1. The Feasibility of Post-Surgery Chemotherapy

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

    Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.

Secondary outcomes

  1. Grade III/IV Adverse Events

    Time frame: every 21-day cycle for 4 cycles

    Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.

  2. Overall Survival at 3 Years

    Time frame: baseline to date of death from any cause, assessed 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.

  3. 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years

    Time frame: length of time disease free, assessed 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.

  4. Overall Survival at 6 Years

    Time frame: Baseline to date of death from any cause assessed 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2013
First posted
Dec 23, 2005
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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