NCT02366143 · OUTCOME

OS in Arm A Versus Arm C by PD-L1 Subgroup

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-09-23

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

Measure: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: Baseline until death (up approximately 53 months)

What was measured

OS in Arm A Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)

Analysis population: PD-L1 WT populations are defined as the PD-L1 populations (TC2/3 or IC2/3 population or TC1/2/3 or IC1/2/3 population) excluding patients with an activating EGFR mutation or ALK translocation.

Groups in this outcome

Arm A (Atezolizumab+Paclitaxel+Carboplatin)

Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

Arm C (Bevacizumab+Paclitaxel+Carboplatin)

Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.

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
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	185
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	165

Reported measurements

TC2/3 or IC2/3 Population

Analysis denominator · Participants

Group	Source count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	124
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	116

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	26.1	Not reported	20.5	40.0	Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	17.0	Not reported	10.3	22.9	Not reported

TC1/2/3 or IC1/2/3 Population

Analysis denominator · Participants

Group	Source count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	185
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	165

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	24.4	Not reported	20.2	28.1	Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	16.0	Not reported	11.2	20.1	Not reported

Source statistical analyses

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

ci Lower Limit
0.551
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.913
group Description
TC1/2/3 or IC1/2/3 ITT-WT
group Ids
OG000
OG001
non Inferiority Comment
Unstratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0073
param Type
Hazard Ratio (HR)
param Value
0.709
statistical Method
Log Rank
ci Lower Limit
0.484
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.907
group Description
TC2/3 or IC2/3 Population
group Ids
OG000
OG001
non Inferiority Comment
Unstratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0097
param Type
Hazard Ratio (HR)
param Value
0.662
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.551
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.913
group Description
TC1/2/3 or IC1/2/3 ITT-WT
group Ids
OG000
OG001
non Inferiority Comment
Unstratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0073
param Type
Hazard Ratio (HR)
param Value
0.709
statistical Method
Log Rank
ci Lower Limit
0.484
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.907
group Description
TC2/3 or IC2/3 Population
group Ids
OG000
OG001
non Inferiority Comment
Unstratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0097
param Type
Hazard Ratio (HR)
param Value
0.662
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
20.5
upper Limit
40.0
value
26.1
group Id
OG001
lower Limit
10.3
upper Limit
22.9
value
17.0
denoms
counts
group Id
OG000
value
124
group Id
OG001
value
116
units
Participants
title
TC2/3 or IC2/3 Population
categories
measurements
group Id
OG000
lower Limit
20.2
upper Limit
28.1
value
24.4
group Id
OG001
lower Limit
11.2
upper Limit
20.1
value
16.0
denoms
counts
group Id
OG000
value
185
group Id
OG001
value
165
units
Participants
title
TC1/2/3 or IC1/2/3 Population

denoms

counts
group Id
OG000
value
185
group Id
OG001
value
165
units
Participants

description

OS in Arm A Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population)

dispersion Type

95% Confidence Interval

groups

description
Participants received intravenous (IV) infusion of atezolizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
id
OG000
title
Arm A (Atezolizumab+Paclitaxel+Carboplatin)
description
Participants received IV infusion of bevacizumab on Day 1 of each 21-day cycle followed by IV infusion of paclitaxel and carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles or loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of bevacizumab during maintenance treatment phase until progressive disease, unacceptable toxicity, or death.
id
OG001
title
Arm C (Bevacizumab+Paclitaxel+Carboplatin)

param Type

MEDIAN

population Description

PD-L1 WT populations are defined as the PD-L1 populations (TC2/3 or IC2/3 population or TC1/2/3 or IC1/2/3 population) excluding patients with an activating EGFR mutation or ALK translocation.

reporting Status

POSTED

time Frame

Baseline until death (up approximately 53 months)

title

OS in Arm A Versus Arm C by PD-L1 Subgroup

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice