NCT02366143 · OUTCOME

PFS, as Determined by the Investigator in Arm B Versus Arm C in 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 disease progression or death, whichever occurs first (up to approximately 29 months)

What was measured

PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.

Analysis population: Teff-high population is defined as the 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 B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)

Participants received IV infusion of atezolizumab and 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 until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.

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 B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	400
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	400

Reported measurements

Teff-high Population

Analysis denominator · Participants

Group	Source count
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	166
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	148

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	11.3	Not reported	9.1	13.0	Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	6.8	Not reported	5.8	7.3	Not reported

ITT Population

Analysis denominator · Participants

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

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm B (Atezolizumab+Bevacizumab+Paclitaxel + Carboplatin)	8.3	Not reported	7.9	9.8	Not reported
Arm C (Bevacizumab+Paclitaxel+Carboplatin)	6.8	Not reported	6.0	7.1	Not reported

Source statistical analyses

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

ci Lower Limit
0.374
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.649
group Description
Teff-high Population
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.492
statistical Method
Log Rank
ci Lower Limit
0.517
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.720
group Description
ITT Population
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.610
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.374
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.649
group Description
Teff-high Population
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.492
statistical Method
Log Rank
ci Lower Limit
0.517
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.720
group Description
ITT Population
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.610
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
9.1
upper Limit
13.0
value
11.3
group Id
OG001
lower Limit
5.8
upper Limit
7.3
value
6.8
denoms
counts
group Id
OG000
value
166
group Id
OG001
value
148
units
Participants
title
Teff-high Population
categories
measurements
group Id
OG000
lower Limit
7.9
upper Limit
9.8
value
8.3
group Id
OG001
lower Limit
6.0
upper Limit
7.1
value
6.8
denoms
counts
group Id
OG000
value
400
group Id
OG001
value
400
units
Participants
title
ITT Population

denoms

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

description

PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population.

dispersion Type

95% Confidence Interval

groups

description
Participants received IV infusion of atezolizumab and 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 until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants received IV infusion of atezolizumab until loss of clinical benefit and bevacizumab until progressive disease, unacceptable toxicity, or death during maintenance treatment phase.
id
OG000
title
Arm B (Atezolizumab+Bevacizumab+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 population is defined as the 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 disease progression or death, whichever occurs first (up to approximately 29 months)

title

PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice