NCT01139775 · OUTCOME

Phase 2: Overall Survival

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: MEDIAN
Unit: months
Interval / dispersion: 90% Confidence Interval
Time frame: Randomization to the date of death from any cause through the time of study discontinuation (approximately 12 months after last participant was randomized)

What was measured

Overall survival (OS) time is defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.

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

Group	Source count
Phase 2: Pemetrexed + Cisplatin + LY2603618	39
Phase 2: Pemetrexed + Cisplatin	23

Reported measurements

Source class 1

Values in months · Interval/dispersion: 90% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Pemetrexed + Cisplatin + LY2603618	12.9	Not reported	9.3	NA	The upper bound of the 90% confidence interval was not calculable.
Phase 2: Pemetrexed + Cisplatin	6.6	Not reported	4.2	19.4	Not reported

Source statistical analyses

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

ci Num Sides
TWO_SIDED
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2294
p Value Comment
The test of treatment effect was conducted at a 2-sided alpha level of 0.10.
statistical Method
Log Rank

Complete source fields

analyses

ci Num Sides
TWO_SIDED
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.2294
p Value Comment
The test of treatment effect was conducted at a 2-sided alpha level of 0.10.
statistical Method
Log Rank

classes

categories
measurements
comment
The upper bound of the 90% confidence interval was not calculable.
group Id
OG000
lower Limit
9.3
upper Limit
NA
value
12.9
group Id
OG001
lower Limit
4.2
upper Limit
19.4
value
6.6

denoms

counts
group Id
OG000
value
39
group Id
OG001
value
23
units
Participants

description

dispersion Type

90% Confidence Interval

groups

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
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

MEDIAN

population Description

All randomized Phase 2 participants.

reporting Status

POSTED

time Frame

Randomization to the date of death from any cause through the time of study discontinuation (approximately 12 months after last participant was randomized)

title

Phase 2: Overall Survival

type

SECONDARY

unit Of Measure

months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice