NCT04222972 · OUTCOME
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 50 months
What was measured
ECOG is a 6-point scale (0-5) used to assess participants functional status, where, 0= Fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2= ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.
Analysis population: Safety-evaluable population included all participants who receive any amount of any study drug. As specified in the protocol, assessment of this outcome measure was limited to the treatment period, 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).
Arm C: Crossover Period- Pralsetinib
Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity 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 | 104 |
|---|
| Arm B: Treatment Period- Pralsetinib | 108 |
|---|
| Arm C: Crossover Period- Pralsetinib | 38 |
|---|
Reported measurements
Baseline ECOG Score 0: Post-baseline Score 0
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 0: Post-baseline Score 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 0: Post-baseline Score 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 0: Post-baseline Score 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 0: Post-baseline ECOG Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 1: Post-baseline Score 0
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 1: Post-baseline ECOG 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 46 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 44 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 1: Post-baseline ECOG 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 1: Post-baseline ECOG 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 1: Post-baseline ECOG 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 1: Post-baseline ECOG Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Baseline ECOG Score 2: Post-baseline ECOG Missing
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Arm A: Treatment Period- SOC | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm B: Treatment Period- Pralsetinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Arm C: Crossover Period- Pralsetinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 3
- title
- Baseline ECOG Score 0: Post-baseline Score 0
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 7
- title
- Baseline ECOG Score 0: Post-baseline Score 1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- title
- Baseline ECOG Score 0: Post-baseline Score 2
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- title
- Baseline ECOG Score 0: Post-baseline Score 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Baseline ECOG Score 0: Post-baseline ECOG Missing
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- Baseline ECOG Score 1: Post-baseline Score 0
- categories
- measurements
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 17
- title
- Baseline ECOG Score 1: Post-baseline ECOG 1
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 4
- title
- Baseline ECOG Score 1: Post-baseline ECOG 2
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- title
- Baseline ECOG Score 1: Post-baseline ECOG 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- title
- Baseline ECOG Score 1: Post-baseline ECOG 4
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- Baseline ECOG Score 1: Post-baseline ECOG Missing
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Baseline ECOG Score 2: Post-baseline ECOG Missing
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 108
- group Id
- OG002
- value
- 38
- units
- Participants
- description
- ECOG is a 6-point scale (0-5) used to assess participants functional status, where, 0= Fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2= ambulatory \& capable of all self-care but unable to carry out any work activities. Up \& about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.
- 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
- description
- Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
- id
- OG002
- title
- Arm C: Crossover Period- Pralsetinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety-evaluable population included all participants who receive any amount of any study drug. As specified in the protocol, assessment of this outcome measure was limited to the treatment period, as the objective was to compare pralsetinib with SOC platinum-containing anticancer treatment regimens.
- reporting Status
- POSTED
- time Frame
- Baseline up to 50 months
- title
- Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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