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NCT01139775 · OUTCOME

Phase 2: Clinical Benefit Rate: Percentage of Participant Who Achieved a Response of Stable Disease (SD), Partial Response (PR), or Complete Response (CR)

A Study in Non Small Cell Lung Cancer · Source last updated 2018-05-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Randomization until date of disease progression or death (up to 6 months after the last participant was randomized)

What was measured

Clinical benefit rate is the best response CR, PR, or SD as classified by the investigators according to the RECIST, v1.1 guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.

Analysis population: All randomized Phase 2 participants.

Groups in this outcome

Phase 2: Pemetrexed + Cisplatin + LY2603618

Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.

Phase 2: Pemetrexed + Cisplatin

Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 2: Pemetrexed + Cisplatin + LY260361839
Phase 2: Pemetrexed + Cisplatin23

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Pemetrexed + Cisplatin + LY260361869.2Not reported52.083.0Not reported
Phase 2: Pemetrexed + Cisplatin47.8Not reported27.069.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0946
    p Value Comment
    The test of treatment effect was conducted at a 2-sided alpha level of 0.10.
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0946
    p Value Comment
    The test of treatment effect was conducted at a 2-sided alpha level of 0.10.
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52.0
        upper Limit
        83.0
        value
        69.2
      2. group Id
        OG001
        lower Limit
        27.0
        upper Limit
        69.0
        value
        47.8
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      23
    units
    Participants
description
Clinical benefit rate is the best response CR, PR, or SD as classified by the investigators according to the RECIST, v1.1 guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
dispersion Type
90% Confidence Interval
groups
  1. description
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    OG000
    title
    Phase 2: Pemetrexed + Cisplatin + LY2603618
  2. description
    Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
    id
    OG001
    title
    Phase 2: Pemetrexed + Cisplatin
param Type
NUMBER
population Description
All randomized Phase 2 participants.
reporting Status
POSTED
time Frame
Randomization until date of disease progression or death (up to 6 months after the last participant was randomized)
title
Phase 2: Clinical Benefit Rate: Percentage of Participant Who Achieved a Response of Stable Disease (SD), Partial Response (PR), or Complete Response (CR)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice