Trial · NCT03052608
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
NCT03052608, Phase 3, Active not recruiting, Pfizer; results first posted 2021-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC. Trials, record NCT03052608. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03052608
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
- NCT number
- NCT03052608
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 296 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Lorlatinib, Crizotinib
- First posted
- 2017-02-14
- Last updated
- 2025-11-25
- Results first posted
- 2021-04-01
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment | From time of Study Start up to 33 months | PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by the independent radiologist or death due to any cause, whichever occurred first. PFS (in months) was calculated as (date of event or censoring-randomization+1)/30.4375. Progressive disease is defined per RECIST version 1.1, as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. |
| Secondary | Overall Survival (OS) | From time of Study Start up to 33 months | OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death or censoring - start date +1)/30.4375. Participants last known to be alive were censored at date of last contact. |
| Secondary | Progression-Free Survival (PFS) Based on Investigator's Assessment | From time of Study Start up to 33 months | PFS was defined as the time from randomization to the date of the first documentation of progressive disease as assessed by investigator or death due to any cause, whichever occurred first. PFS (in months) was calculated as (date of event or censoring-randomization+1)/30.4375. Progressive disease is defined per RECIST version 1.1, as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. |
| Secondary | Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment | From time of Study Start up to 33 months | ORR was the percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Secondary | Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on Investigator's Assessment | From time of Study Start up to 33 months | ORR was the percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Secondary | Intracranial Objective Response Rate (IC-ORR) - Percentage of Participants With Intracranial Objective Response (IC-OR) Based on BICR Assessment | From time of Study Start up to 33 months | IC-ORR was the percentage of participant with intracranial objective response of complete response (CR) or partial response (PR) based on intracranial disease in the subset of participants with at least 1 intracranial lesion per RECIST version 1.1 (modified) recorded from randomization until disease progression or start of new anti-cancer therapy. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Secondary | Intracranial Time to Progression (IC-TTP) Based on BICR Assessment | From time of Study Start up to 33 months | IC-TTP based on BICR assessment was defined as the time from date of randomization to the date of the first documentation of progression of intracranial disease, based on either new brain metastases or progression of existing brain metastases. |
| Secondary | Duration of Response (DR) Based on BICR Assessment | From time of Study Start up to 33 months | DR was defined, for participants with a confirmed objective response (OR) of complete response (CR) or partial response (PR) per RECIST version 1.1, as the time from the first documentation of OR to the first documentation of progressive disease (PD) or death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. |
| Secondary | Intracranial Duration of Response (IC-DR) Based on BICR Assessment | From time of Study Start up to 33 months | IC-DR was defined, for participants with a confirmed intracranial objective response (OR) of complete response (CR) or partial response (PR) per RECIST version 1.1, as the time from the first documentation of intracranial OR to the first documentation of intracranial progressive disease (PD) or death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. |
| Secondary | Time to Tumor Response (TTR) Based on BICR Assessment | From time of Study Start up to 33 months | TTR based on BICR assessment was defined, for participants with a confirmed objective response, as the time from the date of randomization to the first documentation of objective response (complete response or partial response) which was subsequently confirmed. Complete response was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). Partial response was defined as at least a 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment | From time of Study Start up to 33 months | The full analysis (FA) population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Based on Investigator's Assessment | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on Investigator's Assessment | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Intracranial Objective Response Rate (IC-ORR) - Percentage of Participants With Intracranial Objective Response (IC-OR) Based on BICR Assessment | From time of Study Start up to 33 months | The subset of the FA population with at least 1 baseline intracranial lesion (based on BICR intracranial assessment). | Percentage of participants | NUMBER |
| SECONDARY | Intracranial Time to Progression (IC-TTP) Based on BICR Assessment | From time of Study Start up to 33 months | The FA population included all participants who were randomized, and participants were classified according to the treatment assigned at randomization. | Months | MEDIAN |
| SECONDARY | Duration of Response (DR) Based on BICR Assessment | From time of Study Start up to 33 months | Participants with a confirmed objective response (complete response or partial response) per RECIST version 1.1 in the FA population. | Months | MEDIAN |
| SECONDARY | Intracranial Duration of Response (IC-DR) Based on BICR Assessment | From time of Study Start up to 33 months | Participants with brain metastases at baseline and confirmed intracranial complete response or partial response in the FA population. | Months | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) Based on BICR Assessment | From time of Study Start up to 33 months | Participants with confirmed complete response or partial response in the FA population. | Months | MEDIAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group576
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment | Lorlatinib | NA | 95% Confidence Interval NA to NA | Months | |
| Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment | Crizotinib | 9.3 | 95% Confidence Interval 7.6 to 11.1 | Months | |
| Overall Survival (OS) | Lorlatinib | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | Crizotinib | NA | 95% Confidence Interval NA to NA | Months | |
| Progression-Free Survival (PFS) Based on Investigator's Assessment | Lorlatinib | NA | 95% Confidence Interval NA to NA | Months | |
| Progression-Free Survival (PFS) Based on Investigator's Assessment | Crizotinib | 9.1 | 95% Confidence Interval 7.4 to 10.9 | Months | |
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment | Lorlatinib | 75.8 | 95% Confidence Interval 68.2 to 82.5 | Percentage of participants | |
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment | Crizotinib | 57.8 | 95% Confidence Interval 49.4 to 65.9 | Percentage of participants | |
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on Investigator's Assessment | Lorlatinib | 80.5 | 95% Confidence Interval 73.3 to 86.6 | Percentage of participants | |
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on Investigator's Assessment | Crizotinib | 61.9 | 95% Confidence Interval 53.5 to 69.8 | Percentage of participants |
1 to 10 of 576Source ClinicalTrials.gov
See all 576 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | Lorlatinib | 149 | |
| Treatment Phase | STARTED | Crizotinib | 147 | |
| Treatment Phase | COMPLETED | Lorlatinib | 26 | |
| Treatment Phase | COMPLETED | Crizotinib | 83 | |
| Treatment Phase | NOT COMPLETED | Lorlatinib | 123 | |
| Treatment Phase | NOT COMPLETED | Crizotinib | 64 | |
| Long-Term Follow-up Phase | STARTED | Lorlatinib | 149 | |
| Long-Term Follow-up Phase | STARTED | Crizotinib | 147 | |
| Long-Term Follow-up Phase | COMPLETED | Lorlatinib | 0 | |
| Long-Term Follow-up Phase | COMPLETED | Crizotinib | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events336
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Lorlatinib | 29 | 149 | |
| other | Anaemia | Blood and lymphatic system disorders | Crizotinib | 11 | 142 | |
| other | Neutropenia | Blood and lymphatic system disorders | Lorlatinib | 10 | 149 | |
| other | Neutropenia | Blood and lymphatic system disorders | Crizotinib | 21 | 142 | |
| other | Bradycardia | Cardiac disorders | Lorlatinib | 2 | 149 | |
| other | Bradycardia | Cardiac disorders | Crizotinib | 17 | 142 | |
| other | Sinus bradycardia | Cardiac disorders | Lorlatinib | 4 | 149 | |
| other | Sinus bradycardia | Cardiac disorders | Crizotinib | 15 | 142 | |
| other | Tinnitus | Ear and labyrinth disorders | Lorlatinib | 9 | 149 | |
| other | Tinnitus | Ear and labyrinth disorders | Crizotinib | 1 | 142 |
1 to 10 of 336Source ClinicalTrials.gov
See all 336 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lorlatinib | 23 | 149 |
| Total, all-cause mortality | Crizotinib | 28 | 142 |
| Total, other adverse events | Lorlatinib | 148 | 149 |
| Total, other adverse events | Crizotinib | 140 | 142 |
| Total, serious adverse events | Lorlatinib | 51 | 149 |
| Total, serious adverse events | Crizotinib | 39 | 142 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lorlatinib vs Crizotinib: Number of Participants With Maximum Decrease From Baseline Greater Than or Equal to 20 Points in Left Ventricular Ejection Fraction (LVEF) Percentage | Trial comparisons |
| Lorlatinib vs Crizotinib: deaths from any cause | Trial comparisons |
| Lorlatinib vs Crizotinib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03052608
GET https://conductscience.org/api/trials/v1/NCT03052608/registered?page=2