NCT04222972 · OUTCOME

Arm A vs Arm B: Overall Survival (OS)

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-03-05

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: From randomization to death (up to approximately 50 months)

What was measured

OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. 95% CI for median was computed using the method of Brookmeyer and Crowley.

Analysis population: ITT population included all randomized participants whether or not the assigned study treatment was received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.

Groups in this outcome

Arm A: Treatment Period- SOC

Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.

Arm B: Treatment Period- Pralsetinib

Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).

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: Treatment Period- SOC	113
Arm B: Treatment Period- Pralsetinib	110

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Treatment Period- SOC	39.8	Not reported	39.8	NA	Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
Arm B: Treatment Period- Pralsetinib	NA	Not reported	29.6	NA	Median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.

Source statistical analyses

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

ci Lower Limit
0.65
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.85
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.7423
param Type
Hazard Ratio (HR)
param Value
1.09
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.65
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.85
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.7423
param Type
Hazard Ratio (HR)
param Value
1.09
statistical Method
Log Rank

classes

categories
measurements
comment
Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
group Id
OG000
lower Limit
39.8
upper Limit
NA
value
39.8
comment
Median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.
group Id
OG001
lower Limit
29.6
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
113
group Id
OG001
value
110
units
Participants

description

OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. 95% CI for median was computed using the method of Brookmeyer and Crowley.

dispersion Type

95% Confidence Interval

groups

description
Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
id
OG000
title
Arm A: Treatment Period- SOC
description
Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
id
OG001
title
Arm B: Treatment Period- Pralsetinib

param Type

MEDIAN

population Description

ITT population included all randomized participants whether or not the assigned study treatment was received. As specified in the protocol, assessment of this outcome measure was limited to Arms A and B, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.

reporting Status

POSTED

time Frame

From randomization to death (up to approximately 50 months)

title

Arm A vs Arm B: Overall Survival (OS)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice