NCT02367781 · OUTCOME

Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-08-09

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

Measure: NUMBER
Unit: Percentage of participants
Interval / dispersion: Not reported
Time frame: Up to approximately 41 months after first subject enrolled

What was measured

ORR (confirmation not required) is defined as the proportion of participants with an objective response, either CR or PR, with the use of RECIST v1.1, as determined by the investigator in the ITT-WT population.

Analysis population: The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation

Groups in this outcome

Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)

Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 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 B (Nab-Paclitaxel+Carboplatin)

Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.

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+Nab-Paclitaxel+Carboplatin)	452
Arm B (Nab-Paclitaxel+Carboplatin)	227

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)	60.2	Not reported	Not reported	Not reported	Not reported
Arm B (Nab-Paclitaxel+Carboplatin)	41.0	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
11.05
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
27.37
estimate Comment
Wald with Continuity Correction
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
<.0001
param Type
Difference in Response Rate
param Value
19.21
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
11.05
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
27.37
estimate Comment
Wald with Continuity Correction
group Ids
OG000
OG001
non Inferiority Comment
Stratified Analysis
non Inferiority Type
SUPERIORITY
p Value
<.0001
param Type
Difference in Response Rate
param Value
19.21
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
value
60.2
group Id
OG001
value
41.0

denoms

counts
group Id
OG000
value
452
group Id
OG001
value
227
units
Participants

description

groups

description
Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 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+Nab-Paclitaxel+Carboplatin)
description
Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants will receive best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed is also permitted. Participants who were consented prior to approval of protocol Version 5 will be given the option to cross over to receive atezolizumab as monotherapy until disease progression.
id
OG001
title
Arm B (Nab-Paclitaxel+Carboplatin)

param Type

NUMBER

population Description

The ITT- WT population was defined as the ITT population excluding participants with an activating EGFR mutation or ALK translocation

reporting Status

POSTED

time Frame

Up to approximately 41 months after first subject enrolled

title

Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice