Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02998528 · OUTCOME

Major Pathologic Response (MPR) 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

Major pathologic response (MPR) rate is defined as number of randomized participants with \</= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.

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

GroupSource count
Arm B: Platinum Doublet Chemo179
Arm C: Nivo 360 mg + Platinum Doublet Chemo179

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm B: Platinum Doublet Chemo16Not reportedNot reportedNot reportedNot reported
Arm C: Nivo 360 mg + Platinum Doublet Chemo66Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    19.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    36.1
    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
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    % Difference
    param Value
    27.9
  2. ci Lower Limit
    3.16
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.26
    estimate Comment
    Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    5.70
Complete source fields
analyses
  1. ci Lower Limit
    19.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    36.1
    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
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    % Difference
    param Value
    27.9
  2. ci Lower Limit
    3.16
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.26
    estimate Comment
    Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Odds Ratio (OR)
    param Value
    5.70
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        66
denoms
  1. counts
    1. group Id
      OG000
      value
      179
    2. group Id
      OG001
      value
      179
    units
    Participants
description
Major pathologic response (MPR) rate is defined as number of randomized participants with \</= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
groups
  1. 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
  2. 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
Major Pathologic Response (MPR) Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice