NCT02998528 · OUTCOME

Pathologic Complete Response (pCR) Rate

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-01-06

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From randomization up to a median of 30 months after randomization.

What was measured

Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).

Analysis population: All concurrently randomized participants in Arm C and Arm B

Groups in this outcome

Arm B: Platinum Doublet Chemo

Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

Arm C: Nivo 360 mg + Platinum Doublet Chemo

Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.

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: Platinum Doublet Chemo	179
Arm C: Nivo 360 mg + Platinum Doublet Chemo	179

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm B: Platinum Doublet Chemo	4	Not reported	Not reported	Not reported	Not reported
Arm C: Nivo 360 mg + Platinum Doublet Chemo	43	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
13.0
ci Num Sides
TWO_SIDED
ci Pct Value
99
ci Upper Limit
30.3
estimate Comment
Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
% Difference
param Value
21.6
ci Lower Limit
3.49
ci Num Sides
TWO_SIDED
ci Pct Value
99
ci Upper Limit
55.75
estimate Comment
Strata adjusted odds ratio (Arm C over Concurrent Arm B) the Mantel-Haenszel method. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
13.94
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
13.0
ci Num Sides
TWO_SIDED
ci Pct Value
99
ci Upper Limit
30.3
estimate Comment
Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
% Difference
param Value
21.6
ci Lower Limit
3.49
ci Num Sides
TWO_SIDED
ci Pct Value
99
ci Upper Limit
55.75
estimate Comment
Strata adjusted odds ratio (Arm C over Concurrent Arm B) the Mantel-Haenszel method. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
13.94
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
value
4
group Id
OG001
value
43

denoms

counts
group Id
OG000
value
179
group Id
OG001
value
179
units
Participants

description

groups

description
Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
id
OG000
title
Arm B: Platinum Doublet Chemo
description
Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
id
OG001
title
Arm C: Nivo 360 mg + Platinum Doublet Chemo

param Type

COUNT_OF_PARTICIPANTS

population Description

All concurrently randomized participants in Arm C and Arm B

reporting Status

POSTED

time Frame

From randomization up to a median of 30 months after randomization.

title

Pathologic Complete Response (pCR) Rate

type

PRIMARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice