NCT02366143 · OUTCOME

OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population

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)

Analysis population: Teff-high WT population, defined as Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. Teff-high population, defined as patients in the ITT population with Teff signature expression \>=-1.91. ITT population is defined as all randomized patients, regardless of receipt of the assigned treatment.

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)	402
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	400

Reported measurements

Teff-high WT Population

Analysis denominator · Participants

Group	Source count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	163
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	130

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	21.3	Not reported	17.6	26.3	Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	16.3	Not reported	11.2	22.3	Not reported

Teff-high Population

Analysis denominator · Participants

Group	Source count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	177
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	148

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	21.0	Not reported	17.1	26.0	Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	16.7	Not reported	11.4	21.6	Not reported

ITT Population

Analysis denominator · Participants

Group	Source count
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	402
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	400

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Paclitaxel+Carboplatin)	19.0	Not reported	16.3	21.5	Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	15.0	Not reported	13.4	17.1	Not reported

Source statistical analyses

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

ci Lower Limit
0.595
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.038
group Description
Teff high-WT
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0894
param Type
Hazard Ratio (HR)
param Value
0.786
statistical Method
Log Rank
ci Lower Limit
0.626
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.061
group Description
Teff high
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1276
param Type
Hazard Ratio (HR)
param Value
0.815
statistical Method
Log Rank
ci Lower Limit
0.733
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.011
group Description
ITT
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0681
param Type
Hazard Ratio (HR)
param Value
0.861
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.595
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.038
group Description
Teff high-WT
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0894
param Type
Hazard Ratio (HR)
param Value
0.786
statistical Method
Log Rank
ci Lower Limit
0.626
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.061
group Description
Teff high
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.1276
param Type
Hazard Ratio (HR)
param Value
0.815
statistical Method
Log Rank
ci Lower Limit
0.733
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.011
group Description
ITT
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
0.0681
param Type
Hazard Ratio (HR)
param Value
0.861
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
17.6
upper Limit
26.3
value
21.3
group Id
OG001
lower Limit
11.2
upper Limit
22.3
value
16.3
denoms
counts
group Id
OG000
value
163
group Id
OG001
value
130
units
Participants
title
Teff-high WT Population
categories
measurements
group Id
OG000
lower Limit
17.1
upper Limit
26.0
value
21.0
group Id
OG001
lower Limit
11.4
upper Limit
21.6
value
16.7
denoms
counts
group Id
OG000
value
177
group Id
OG001
value
148
units
Participants
title
Teff-high Population
categories
measurements
group Id
OG000
lower Limit
16.3
upper Limit
21.5
value
19.0
group Id
OG001
lower Limit
13.4
upper Limit
17.1
value
15.0
denoms
counts
group Id
OG000
value
402
group Id
OG001
value
400
units
Participants
title
ITT Population

denoms

counts
group Id
OG000
value
402
group Id
OG001
value
400
units
Participants

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

Teff-high WT population, defined as Teff-high population excluding patients with an activating EGFR mutation or ALK translocation. Teff-high population, defined as patients in the ITT population with Teff signature expression \>=-1.91. ITT population is defined as all randomized patients, regardless of receipt of the assigned treatment.

reporting Status

POSTED

time Frame

Baseline until death (up approximately 53 months)

title

OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice