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NCT02411448 · OUTCOME

Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY) · Source last updated 2026-01-16

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

Measure
GEOMETRIC_MEAN
Unit
microgram per milliliter (µg/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1

What was measured

Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

Analysis population: Part B participants who received at least one dose of Ramucirumab+ Erlotinib who had evaluable PK data. Per protocol, Part A did not evaluate PK.

Groups in this outcome

Part B: Ramucirumab+ Erlotinib

Part B: 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.

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

Analysis denominator · Participants

GroupSource count
Part B: Ramucirumab+ Erlotinib185

Reported measurements

Cycle 2

Analysis denominator · Participants

GroupSource count
Part B: Ramucirumab+ Erlotinib185
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Ramucirumab+ Erlotinib39.632Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Part B: Ramucirumab+ Erlotinib145
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Ramucirumab+ Erlotinib68.537Not reportedNot reportedNot reported
Cycle 7

Analysis denominator · Participants

GroupSource count
Part B: Ramucirumab+ Erlotinib110
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Ramucirumab+ Erlotinib85.732Not reportedNot reportedNot reported
Cycle 14

Analysis denominator · Participants

GroupSource count
Part B: Ramucirumab+ Erlotinib59
Values in microgram per milliliter (µg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Ramucirumab+ Erlotinib99.431Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        32
        value
        39.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        185
      units
      Participants
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        37
        value
        68.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        145
      units
      Participants
    title
    Cycle 4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        32
        value
        85.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      units
      Participants
    title
    Cycle 7
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        31
        value
        99.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Cycle 14
denoms
  1. counts
    1. group Id
      OG000
      value
      185
    units
    Participants
description
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Part B: 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
    id
    OG000
    title
    Part B: Ramucirumab+ Erlotinib
param Type
GEOMETRIC_MEAN
population Description
Part B participants who received at least one dose of Ramucirumab+ Erlotinib who had evaluable PK data. Per protocol, Part A did not evaluate PK.
reporting Status
POSTED
time Frame
Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1
title
Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
type
SECONDARY
unit Of Measure
microgram per milliliter (µg/mL)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice