Trial · NCT04541706

Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India

NCT04541706, Phase 4, Completed, Pfizer; results first posted 2024-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India. Trials, record NCT04541706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04541706

On this page

Trial

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

Title: Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India
NCT number: NCT04541706
Status: Completed
Phases: Phase 4
Enrollment: 100 participants, actual
Lead sponsor: Pfizer
Conditions: Advanced Non-Small Cell Lung Cancer
Interventions: Lorlatinib
First posted: 2020-09-09
Last updated: 2024-12-20
Results first posted: 2024-12-20

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily need to have a causal relationship with the treatment or usage. A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. If the investigator did not know whether or not the investigational product caused the event, then the event would be handled as "related to investigational product" for reporting purposes, as defined by the sponsor. If the investigator's causality assessment was "unknown but not related to investigational product," this was clearly documented on study records.
Secondary	Confirmed Objective Responses Rate (ORR) Based on Investigator Assessment	Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.	ORR was defined as the percentage of participants with best overall response as confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR was provided along with the corresponding 95% confidence interval (CI) based on Wilson's Score Method. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the target lesions.
Secondary	Confirmed Intracranial Objective Response Rate (IC-ORR) Based on Investigator Assessment	Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.	IC-ORR was defined as the percentage of participants with intracranial response (ie, best overall intracranial response as confirmed CR or confirmed PR considering only intracranial lesions) relative to participants with central nervous system (CNS) metastases at study entry. IC-ORR was provided along with the corresponding 95% CI based on Wilson's Score Method. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the target lesions.
Secondary	Duration of Response (DoR)	Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.	DoR was defined as the time from the first documentation of objective tumor response (confirmed CR or confirmed PR) to the first documentation of disease progression or death due to any cause, whichever occurred first. For participants whose responses proceed from PR to CR, the onset of PR was taken as the onset of response. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the target lesions.
Secondary	Intracranial Duration of Response (IC-DoR)	Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.	IC-DoR was defined as the time from the first documentation of an intracranial objective response (confirmed CR or confirmed PR) to the first documentation of disease progression or death due to any cause, whichever occurred first in the subgroup of participants with brain metastasis at baseline. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the target lesions.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From Day 1 up to 35 days post last dosing date or the date of initiation of a new anticancer therapy (up to 1.9 years)	The safety analysis population included participants who received at least 1 dose of lorlatinib.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Confirmed Objective Responses Rate (ORR) Based on Investigator Assessment	Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.	The analysis population included participants who received at least 1 dose of lorlatinib.	Percentage of participants	NUMBER
SECONDARY	Confirmed Intracranial Objective Response Rate (IC-ORR) Based on Investigator Assessment	Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.	The analysis population included participants any intracranial lesions.	Percentage of participants	NUMBER
SECONDARY	Duration of Response (DoR)	Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.	The analysis population included participants with confirmed objective response.	Months	MEDIAN
SECONDARY	Intracranial Duration of Response (IC-DoR)	Assessed at least 1 year from first dose or until progression of disease, death or received subsequent anti-cancer therapy, whichever came first up to a maximum of 2 years.	The analysis population included participants with CNS metastases at baseline and confirmed objective response.	Months	MEDIAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Lorlatinib 100 mg QD	All-causality TEAEs	94		Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Lorlatinib 100 mg QD	Treatment-related TEAEs	89		Participants
Confirmed Objective Responses Rate (ORR) Based on Investigator Assessment	Lorlatinib 100 mg QD		41	95% Confidence Interval 31.9 to 50.8	Percentage of participants
Confirmed Intracranial Objective Response Rate (IC-ORR) Based on Investigator Assessment	Lorlatinib 100 mg QD		35.7	95% Confidence Interval 24.5 to 48.8	Percentage of participants
Duration of Response (DoR)	Lorlatinib 100 mg QD		NA	95% Confidence Interval NA to NA	Months
Intracranial Duration of Response (IC-DoR)	Lorlatinib 100 mg QD		NA	95% Confidence Interval 11.1 to NA	Months

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lorlatinib 100 mg QD	100
Overall Study	COMPLETED	Lorlatinib 100 mg QD	55
Overall Study	NOT COMPLETED	Lorlatinib 100 mg QD	45

Source ClinicalTrials.gov

Adverse events40

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 100 mg QD	26	100
other	Oedema	General disorders	Lorlatinib 100 mg QD	7	100
other	Oedema peripheral	General disorders	Lorlatinib 100 mg QD	29	100
other	Peripheral swelling	General disorders	Lorlatinib 100 mg QD	6	100
other	COVID-19	Infections and infestations	Lorlatinib 100 mg QD	6	100
other	Weight increased	Investigations	Lorlatinib 100 mg QD	39	100
other	Dyslipidaemia	Metabolism and nutrition disorders	Lorlatinib 100 mg QD	7	100
other	Hypercholesterolaemia	Metabolism and nutrition disorders	Lorlatinib 100 mg QD	57	100
other	Hyperglycaemia	Metabolism and nutrition disorders	Lorlatinib 100 mg QD	16	100
other	Hyperlipidaemia	Metabolism and nutrition disorders	Lorlatinib 100 mg QD	20	100

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lorlatinib 100 mg QD	8	100
Total, other adverse events	Lorlatinib 100 mg QD	89	100
Total, serious adverse events	Lorlatinib 100 mg QD	22	100

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT04541706

GET https://conductscience.org/api/trials/v1/NCT04541706/events?page=2

API reference For AI assistants