Trial · NCT04362072

Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer

NCT04362072, Phase 4, Completed, Pfizer; results first posted 2025-06-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer. Trials, record NCT04362072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04362072

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
NCT number: NCT04362072
Status: Completed
Phases: Phase 4
Enrollment: 71 participants, actual
Lead sponsor: Pfizer
Conditions: Carcinoma, Non-Small-Cell Lung
Interventions: Lorlatinib
First posted: 2020-04-24
Last updated: 2025-06-11
Other registries' IDs: eudract:2019-002504-41
Results first posted: 2025-06-11

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Confirmed Overall Objective Response (OR) as Per Independent Central Review (ICR) as Assessed by RECIST v1.1	From date of first dose until documented PD or start of new anti-cancer therapy, whichever occurred earlier (maximum treatment exposure up to 42.78 months)	Confirmed OR based on ICR assessment was defined as complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumor (RECIST) version(v)1.1 from date of first dose until documented progressive disease (PD) or start of new anti-cancer therapy without regard to discontinuation from treatment. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after criteria for response are first met. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of diameters of target, taking as reference baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions was also considered sign of progression. For non-target PD: unequivocal progression of existing non-target lesions.
Secondary	Percentage of Participants With Confirmed OR as Per Investigator (INV) as Assessed by RECIST v 1.1	From date of first dose until documented PD or start of new anti-cancer therapy, whichever occurred earlier (maximum treatment exposure up to 42.78 months)	Confirmed OR based on derived investigator assessment was defined as CR or PR according to RECIST v1.1 from date of first dose until PD or start of new anti-cancer therapy without regard to discontinuation from treatment. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after criteria for response are first met. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of diameters of target, taking as reference baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered sign of progression. For non-target PD: unequivocal progression of existing non-target lesions.
Secondary	Percentage of Participants With Confirmed Intracranial (IC) Objective Response (IC-OR) as Per ICR as Assessed by RECIST v 1.1	From date of first dose until documented PD or start of new anti-cancer therapy, whichever occurred earlier (maximum treatment exposure up to 42.78 months)	IC-OR based on ICR assessment was defined as IC-CR or PR according to RECIST v1.1 from date of first dose until documented IC-PD or start of new anti-cancer therapy without regard to discontinuation from treatment. Both IC-CR and IC-PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of diameters of target, taking as reference baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered sign of progression. For non-target PD: unequivocal progression of existing non-target lesions.
Secondary	Percentage of Participants With Confirmed IC-OR as Per INV as Assessed by RECIST v 1.1	From date of first dose until documented PD or start of new anti-cancer therapy, whichever occurred earlier (maximum treatment exposure up to 42.78 months)	IC-OR based on derived investigator assessment was defined as IC-CR or PR according to RECIST v1.1 from date of first dose until documented IC-PD or start of new anti-cancer therapy without regard to discontinuation from treatment. Both IC-CR and IC-PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of diameters of target, taking as reference baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered sign of progression. For non-target PD: unequivocal progression of existing non-target lesions.
Secondary	Time to Response (TTR) as Per ICR as Assessed by RECIST v 1.1	From date of first dose until first documented objective response, CR or PR (maximum treatment exposure up to 42.78 months)	TTR based on ICR assessments was defined, for participants with a confirmed OR, as the time from the date of first dose to the first documentation of OR (CR or PR) which was subsequently confirmed. For participants whose OR proceeded from PR to CR, the onset of PR was taken as the onset of response. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of diameters of target, taking as reference baseline sum diameters.
Secondary	TTR as Per INV as Assessed by RECIST v 1.1	From date of first dose until first documented objective response, CR or PR (maximum treatment exposure up to 42.78 months)	TTR based on derived investigator assessments was defined, for participants with a confirmed objective response, as the time from the date of first dose to the first documentation of objective response (CR or PR) which is subsequently confirmed. For participants whose OR proceeds from PR to CR, the onset of PR is taken as the onset of response. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of diameters of target, taking as reference baseline sum diameters.
Secondary	Duration of Response (DOR) as Per ICR as Assessed by RECIST v 1.1	From first documented OR (CR or PR) to date of first documented PD or death due to any cause or censoring date, whichever occurred first (maximum treatment exposure up to 42.78 months)	DOR: for participants with confirmed OR per ICR, as time from first documentation of OR (CR/PR whichever was earlier) to date of first documentation of PD/death due to any cause, whichever occurred first. CR:disappearance of all target and non-target lesions. PR:at least 30 % decrease in sum of diameters of target, taking as reference baseline sum diameters. PD:at least 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study. Addition to relative increase of 20%, sum must also demonstrate absolute increase of at least 5mm. Appearance of one/ more new lesions: sign of progression. For non-target PD:unequivocal progression of existing non-target lesions. Participants who completed/discontinued study without PD/death, as well as who received alternate anti-cancer therapy prior to PD, were censored at their last adequate response assessment date/last adequate assessment prior to start date of alternate anti-cancer therapy. Analysis:Kaplan-Meier method.
Secondary	DOR as Per INV as Assessed by RECIST v 1.1	From first documented OR (CR or PR) to date of first documented PD or death due to any cause or censoring date, whichever occurred first (maximum treatment exposure up to 42.78 months)	DOR: for participants with confirmed OR per investigator,as time from first documentation of OR(CR/PR whichever was earlier) to date of first documentation of PD/death due to any cause, whichever occurred first. CR:disappearance of all target and non-target lesions. PR:at least 30% decrease in sum of diameters of target,taking as reference baseline sum diameters. PD:at least 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study. Addition to relative increase of 20%,sum must also demonstrate absolute increase of at least 5mm. Appearance of one/more new lesions:sign of progression. For non-target PD:unequivocal progression of existing non-target lesions. Participants who completed/discontinued study without PD/death,as well as who received alternate anti-cancer therapy prior to PD,were censored at their last adequate response assessment date/last adequate assessment prior to start date of alternate anti-cancer therapy. Analysis:Kaplan-Meier method.
Secondary	Duration of Intracranial Response (IC-DoR) as Per ICR as Assessed by RECIST v 1.1	From first documented IC-OR (CR or PR) to date of first documented PD or death due to any cause or censoring date, whichever occurred first (maximum treatment exposure up to 42.78 months)	IC-DoR: for participants with confirmed objective intra-cranial response per ICR, as time from first documentation of objective intra-cranial response (CR/PR whichever is earlier) to date of first documentation of PD in brain or death due to any cause, whichever occurs first. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of diameters of target, taking as reference baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. Appearance of one/more new lesions:sign of progression. For non-target PD: unequivocal progression of existing non-target lesions. Participants who completed or discontinued study without PD or death, as well as participants who received alternate anti-cancer therapy prior to PD, were censored at their last adequate response assessment date or last adequate assessment prior to start date of alternate anti-cancer therapy. Analysis: Kaplan-Meier method.
Secondary	IC-DoR as Per INV as Assessed by RECIST v 1.1	From first documented IC-OR (CR or PR) to date of first documented PD or death due to any cause or censoring date, whichever occurred first (maximum treatment exposure up to 42.78 months)	IC-DoR: for participants with confirmed objective intra-cranial response, per investigator as time from first documentation of objective intra-cranial response (CR or PR whichever is earlier) to date of first documentation of PD in brain or death due to any cause, whichever occurs first. CR: disappearance of all target and non-target lesions. PR: at least 30 % decrease in sum of diameters of target, taking as reference baseline sum diameters. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. Appearance of one/more new lesions: sign of progression. For non-target PD: unequivocal progression of existing non-target lesions. Participants who completed or discontinued study without PD or death, as well as who received alternate anti-cancer therapy prior to PD, were censored at their last adequate response assessment date or last adequate assessment prior to start date of alternate anti-cancer therapy. Analysis: Kaplan-Meier method.

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Confirmed Overall Objective Response (OR) as Per Independent Central Review (ICR) as Assessed by RECIST v1.1	From date of first dose until documented PD or start of new anti-cancer therapy, whichever occurred earlier (maximum treatment exposure up to 42.78 months)	Intent to treat (ITT) analysis population included all enrolled participants who took at least 1 dose of Lorlatinib.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Confirmed OR as Per Investigator (INV) as Assessed by RECIST v 1.1	From date of first dose until documented PD or start of new anti-cancer therapy, whichever occurred earlier (maximum treatment exposure up to 42.78 months)	ITT analysis population included all enrolled participants who took at least 1 dose of Lorlatinib.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Confirmed Intracranial (IC) Objective Response (IC-OR) as Per ICR as Assessed by RECIST v 1.1	From date of first dose until documented PD or start of new anti-cancer therapy, whichever occurred earlier (maximum treatment exposure up to 42.78 months)	Per-protocol analysis population based on ICR (PPICR) included all enrolled participants who took at least 1 dose of Lorlatinib and had central nervous system (CNS) metastases at study entry (i.e. with lesions having disease site = brain) according to ICR.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Confirmed IC-OR as Per INV as Assessed by RECIST v 1.1	From date of first dose until documented PD or start of new anti-cancer therapy, whichever occurred earlier (maximum treatment exposure up to 42.78 months)	Per-protocol analysis population based on (PPINV) included all enrolled participants who took at least 1 dose of Lorlatinib and had CNS metastases at study entry (i.e. with lesions having disease site = brain) according to investigator.	Percentage of participants	NUMBER
SECONDARY	Time to Response (TTR) as Per ICR as Assessed by RECIST v 1.1	From date of first dose until first documented objective response, CR or PR (maximum treatment exposure up to 42.78 months)	Analysis population included all enrolled participants who took at least 1 dose of Lorlatinib and had confirmed CR or PR as per ICR.	Months	MEDIAN
SECONDARY	TTR as Per INV as Assessed by RECIST v 1.1	From date of first dose until first documented objective response, CR or PR (maximum treatment exposure up to 42.78 months)	Analysis population included all enrolled participants who took at least 1 dose of Lorlatinib and had confirmed CR or PR as per INV.	Months	MEDIAN
SECONDARY	Duration of Response (DOR) as Per ICR as Assessed by RECIST v 1.1	From first documented OR (CR or PR) to date of first documented PD or death due to any cause or censoring date, whichever occurred first (maximum treatment exposure up to 42.78 months)	Analysis population included all enrolled participants who took at least 1 dose of Lorlatinib and had confirmed CR or PR as per ICR.	Months	MEDIAN
SECONDARY	DOR as Per INV as Assessed by RECIST v 1.1	From first documented OR (CR or PR) to date of first documented PD or death due to any cause or censoring date, whichever occurred first (maximum treatment exposure up to 42.78 months)	Analysis population included all enrolled participants who took at least 1 dose of Lorlatinib and had confirmed CR or PR as per INV.	Months	MEDIAN
SECONDARY	Duration of Intracranial Response (IC-DoR) as Per ICR as Assessed by RECIST v 1.1	From first documented IC-OR (CR or PR) to date of first documented PD or death due to any cause or censoring date, whichever occurred first (maximum treatment exposure up to 42.78 months)	Per-protocol analysis population based on ICR (PPICR) included all enrolled participants who took at least 1 dose of Lorlatinib and had central nervous system (CNS) metastases at study entry (i.e. with lesions having disease site = brain) according to ICR. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Months	MEDIAN
SECONDARY	IC-DoR as Per INV as Assessed by RECIST v 1.1	From first documented IC-OR (CR or PR) to date of first documented PD or death due to any cause or censoring date, whichever occurred first (maximum treatment exposure up to 42.78 months)	Per-protocol analysis population based on (PPINV) included all enrolled participants who took at least 1 dose of Lorlatinib and had CNS metastases at study entry (i.e. with lesions having disease site = brain) according to investigator. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.	Months	MEDIAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With Confirmed Overall Objective Response (OR) as Per Independent Central Review (ICR) as Assessed by RECIST v1.1	Lorlatinib	42.3	95% Confidence Interval 30.6 to 54.6	Percentage of participants
Percentage of Participants With Confirmed OR as Per Investigator (INV) as Assessed by RECIST v 1.1	Lorlatinib	36.6	95% Confidence Interval 25.5 to 48.9	Percentage of participants
Percentage of Participants With Confirmed Intracranial (IC) Objective Response (IC-OR) as Per ICR as Assessed by RECIST v 1.1	Lorlatinib	46.7	95% Confidence Interval 28.3 to 65.7	Percentage of participants
Percentage of Participants With Confirmed IC-OR as Per INV as Assessed by RECIST v 1.1	Lorlatinib	56.5	95% Confidence Interval 34.5 to 76.8	Percentage of participants
Time to Response (TTR) as Per ICR as Assessed by RECIST v 1.1	Lorlatinib	1.5	Full Range 1.2 to 8.4	Months
TTR as Per INV as Assessed by RECIST v 1.1	Lorlatinib	1.6	Full Range 1.2 to 8.3	Months
Duration of Response (DOR) as Per ICR as Assessed by RECIST v 1.1	Lorlatinib	NA	95% Confidence Interval 8.6 to NA	Months
DOR as Per INV as Assessed by RECIST v 1.1	Lorlatinib	20.9	95% Confidence Interval 9.9 to NA	Months
Duration of Intracranial Response (IC-DoR) as Per ICR as Assessed by RECIST v 1.1	Lorlatinib	NA	95% Confidence Interval NA to NA	Months
IC-DoR as Per INV as Assessed by RECIST v 1.1	Lorlatinib	NA	95% Confidence Interval NA to NA	Months

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment	STARTED	Lorlatinib	71
Treatment	COMPLETED	Lorlatinib	0
Treatment	NOT COMPLETED	Lorlatinib	71
Follow up	STARTED	Lorlatinib	35
Follow up	COMPLETED	Lorlatinib	31
Follow up	NOT COMPLETED	Lorlatinib	4

Source ClinicalTrials.gov

Adverse events58

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
other	Anaemia	Blood and lymphatic system disorders	Lorlatinib 100mg	12	71
other	Diarrhoea	Gastrointestinal disorders	Lorlatinib 100mg	13	71
other	Nausea	Gastrointestinal disorders	Lorlatinib 100mg	6	71
other	Vomiting	Gastrointestinal disorders	Lorlatinib 100mg	6	71
other	Asthenia	General disorders	Lorlatinib 100mg	14	71
other	Fatigue	General disorders	Lorlatinib 100mg	5	71
other	Oedema	General disorders	Lorlatinib 100mg	6	71
other	Oedema peripheral	General disorders	Lorlatinib 100mg	26	71
other	Pyrexia	General disorders	Lorlatinib 100mg	12	71
other	COVID-19	Infections and infestations	Lorlatinib 100mg	8	71

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lorlatinib 100mg	20	71
Total, other adverse events	Lorlatinib 100mg	66	71
Total, serious adverse events	Lorlatinib 100mg	23	71

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41949116	DERIVED

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04362072

GET https://conductscience.org/api/trials/v1/NCT04362072/registered?page=2

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