NCT03052608 · OUTCOME
Number of Participant With ALK Domain Mutation in Plasma Circulating Nucleic Acid (CNA) Analysis at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC · Source last updated 2025-11-25
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
- at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
What was measured
The analysis of anaplastic lymphoma kinase (ALK) domain mutation in plasma CNA was performed by next-generation sequencing (NGS) and the number of participants with one or more ALK mutations at Screening, Cycle 2 Day 1 and Cycle 7 Day 1 is presented here.
Analysis population: "Number of Participants Analyzed" included all participants in the plasma CNA analysis population within each treatment group at screening. "Number Analyzed" included all participants in the plasma CNA analysis population within each treatment group at the specified visit.
Groups in this outcome
Lorlatinib
Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
Crizotinib
Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
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 |
|---|
| Lorlatinib | 130 |
|---|
| Crizotinib | 125 |
|---|
Reported measurements
at Screening
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 130 |
|---|
| Crizotinib | 125 |
|---|
≥1 ALK Mutation Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
No ALK Mutation Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 88 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 91 | Not reported | Not reported | Not reported | Not reported |
|---|
No Circulating Free Deoxyribonucleic Acid (cfDNA) Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
Other (Sample failed analysis, uninformative, or not analyzed.)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 125 |
|---|
| Crizotinib | 118 |
|---|
≥1 ALK Mutation Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
No ALK Mutation Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 66 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 55 | Not reported | Not reported | Not reported | Not reported |
|---|
No Circulating Free Deoxyribonucleic Acid (cfDNA) Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 53 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 58 | Not reported | Not reported | Not reported | Not reported |
|---|
Other (Sample failed analysis, uninformative, or not analyzed.)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 7 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Lorlatinib | 103 |
|---|
| Crizotinib | 84 |
|---|
≥1 ALK Mutation Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
No ALK Mutation Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 42 | Not reported | Not reported | Not reported | Not reported |
|---|
No Circulating Free Deoxyribonucleic Acid (cfDNA) Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Other (Sample failed analysis, uninformative, or not analyzed.)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Lorlatinib | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Crizotinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- title
- ≥1 ALK Mutation Detected
- measurements
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 91
- title
- No ALK Mutation Detected
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 25
- title
- No Circulating Free Deoxyribonucleic Acid (cfDNA) Detected
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- title
- Other (Sample failed analysis, uninformative, or not analyzed.)
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 125
- units
- Participants
- title
- at Screening
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- ≥1 ALK Mutation Detected
- measurements
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 55
- title
- No ALK Mutation Detected
- measurements
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 58
- title
- No Circulating Free Deoxyribonucleic Acid (cfDNA) Detected
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- title
- Other (Sample failed analysis, uninformative, or not analyzed.)
- denoms
- counts
- group Id
- OG000
- value
- 125
- group Id
- OG001
- value
- 118
- units
- Participants
- title
- Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- title
- ≥1 ALK Mutation Detected
- measurements
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 42
- title
- No ALK Mutation Detected
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 35
- title
- No Circulating Free Deoxyribonucleic Acid (cfDNA) Detected
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- title
- Other (Sample failed analysis, uninformative, or not analyzed.)
- denoms
- counts
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 84
- units
- Participants
- title
- Cycle 7 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 125
- units
- Participants
- description
- The analysis of anaplastic lymphoma kinase (ALK) domain mutation in plasma CNA was performed by next-generation sequencing (NGS) and the number of participants with one or more ALK mutations at Screening, Cycle 2 Day 1 and Cycle 7 Day 1 is presented here.
- groups
- description
- Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- id
- OG000
- title
- Lorlatinib
- description
- Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
- id
- OG001
- title
- Crizotinib
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- "Number of Participants Analyzed" included all participants in the plasma CNA analysis population within each treatment group at screening. "Number Analyzed" included all participants in the plasma CNA analysis population within each treatment group at the specified visit.
- reporting Status
- POSTED
- time Frame
- at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
- title
- Number of Participant With ALK Domain Mutation in Plasma Circulating Nucleic Acid (CNA) Analysis at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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