Clinical Trial: RAD001 With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced Large Cell Lung Cancer With Neuroendocrine Differentiation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-centric, Open-label, Phase II Study Investigating the Combination of Afinitor With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced (Stage IV) Large Cell Lung Cance

Brief Summary: This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Percentage of Participants Progression-free [ Time Frame: 3 months ]

Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.


Original Primary Outcome: The proportion of subjects progression-free at Month 3 (C4D21) according to RECIST (Version 1.1). Time Frame [ Time Frame: 3 months ]

Current Secondary Outcome:

  • Percentage of Participants Progression-free [ Time Frame: 6 months ]
    Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.
  • Percentage of Participants With Overall Response Rate (ORR) [ Time Frame: 3 months ]
    ORR was defined as is the proportion of participants with a best overall response of CR or PR. CR is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response. PR is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions.
  • Percentage of Participants With Disease Control Rate (DCR) [ Time Frame: 3 months ]
    DCR was defined as is the percentage of participants with a best overall response of CR or PR or SD. Complete response (CR) is disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR) is > 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD) is neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; and Progressive disease (PD is: > 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.
  • Progression Free Survival (PFS) [ Time Frame: 6 months ]
    PFS was defined as the time from the date of start of treatment to date of event defined as the first documented progression or death due to any cause.
  • Overall Survival (OS) [ Time Frame: 12 months ]
    OS was defined as the time from date of start of treatment to date of death due to any cause.


Original Secondary Outcome:

  • the proportion of subjects progression-free at Month 6 [ Time Frame: 6 months ]
  • Overall response rate (ORR) is the proportion of patients with a best overall response of CR or PR at Month 3 (C4D21) [ Time Frame: 3 months ]
  • Disease control rate (DCR) is the proportion of patients with a best overall response of CR or PR or SD at Month 3 (C4D21) [ Time Frame: 3 months ]
  • Progression Free Survival [ Time Frame: approximately 3-6 months ]
  • Overall Survival [ Time Frame: estimated 12 months ]


Information By: Novartis

Dates:
Date Received: March 16, 2011
Date Started: April 2011
Date Completion:
Last Updated: February 29, 2016
Last Verified: February 2016