Trial · NCT03909971
A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China
NCT03909971, Phase 2, Completed, Pfizer; results first posted 2021-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China. Trials, record NCT03909971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03909971
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China
- NCT number
- NCT03909971
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Lorlatinib
- First posted
- 2019-04-10
- Last updated
- 2025-11-05
- Results first posted
- 2021-10-26
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response (Cohort 1) | From Cycle 1 Day 1 to documented progression of disease by ICR (up to 67 weeks) | Objective response rate (ORR) was defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 relative to the total participants in the analysis population. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR was defined as a greater than equal to (\>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Independent Central Radiology (ICR) was used for disease progression assessment. |
| Secondary | Percentage of Participants With Objective Response (Cohort 2) | From Cycle 1 Day 1 to documented progression of disease by ICR (up to 67 weeks) | ORR was defined as the percentage of participants with a best overall confirmed response of CR or PR according to RECIST version 1.1 relative to the total participants in the analysis population. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. ICR was used for disease progression assessment. |
| Secondary | Progression-Free Survival (PFS) Based on ICR Assessment | From first dose (Cycle 1 Day 1) to documented PD by ICR, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | PFS was defined as the time from first dose to first documentation of objective disease progression (PD) or to death due to any cause, whichever came first. PD: at least a \>=20 percent (%) increase 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 one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, PD was defined as unequivocal progression of existing non-target lesions, or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. Analysis was performed using Kaplan Meier method. ICR was used for disease progression assessment. |
| Secondary | Progression-Free Survival Based on Investigator Assessment | From first dose (Cycle 1 Day 1) to documented progression of disease by investigator, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | PFS was defined as the time from first dose to first documentation of objective PD or to death due to any cause, whichever came first. PD: at least a \>=20 % increase 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 one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, PD was defined as unequivocal progression of existing non-target lesions, or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. Analysis was performed using Kaplan Meier method. Investigator assessment was used for disease progression assessment. |
| Secondary | Overall Survival | From first dose (Cycle 1 Day 1) to date of death due to any cause (up to 271 weeks of treatment exposure) | Overall survival was defined as the time from first dose to the date of death due to any cause. Analysis was performed using Kaplan Meier method. |
| Secondary | Percentage of Participants With Intracranial Objective Response (IC-OR) Based on ICR Assessment | From first dose (Cycle 1 Day 1) to documented PD by ICR (up to 271 weeks of treatment exposure) | IC-OR: percentage of participants with a best overall confirmed intracranial response of CR or PR according to RECIST version 1.1 relative to total participants in the analysis population but limited to intra cranial lesions only in participants with central nervous system metastases. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as a \>= 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. 95% CI was based on Clopper-Pearson method. |
| Secondary | Percentage of Participants With Intracranial Objective Response Based on Investigator Assessment | From first dose (Cycle 1 Day 1) to documented progression of disease by investigator (up to 271 weeks of treatment exposure) | IC-OR: percentage of participants with a best overall confirmed intracranial response of CR or PR according to RECIST version 1.1 relative to total participants in the analysis population but limited to intra cranial lesions only in participants with central nervous system metastases. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as a \>= 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. 95% CI was based on Clopper-Pearson method |
| Secondary | Duration of Response (DOR) Based on ICR Assessment | From first documentation of CR or PR to documented progression of disease by ICR, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | DOR: time from first documentation of CR or PR to first documentation of PD or death due to any cause, whichever occurred first. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes must have reduction in short axis to \<10mm. PR:\>=30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. PD:\>=20 % increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since treatment started, or the appearance of one or more new lesions. In addition to relative increase of 20% sum must also demonstrate an absolute increase of at least 5 mm and for non-target lesions PD: unequivocal progression of existing non-target lesions or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at time of analysis were censored at date of last tumor assessment. Analysis was performed using Kaplan Meier method. |
| Secondary | DOR Based on Investigator Assessment | From first documentation of CR or PR to documented PD by investigator, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure | DOR: time from first documentation of CR or PR to first documentation of PD or death due to any cause, whichever occurred first. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes must have reduction in short axis to \<10mm. PR:\>=30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. PD:\>=20 % increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since treatment started, or the appearance of one or more new lesions. In addition to relative increase of 20% sum must also demonstrate an absolute increase of at least 5 mm and for non-target lesions PD: unequivocal progression of existing non-target lesions or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at time of analysis were censored at date of last tumor assessment. Analysis was performed using Kaplan Meier method. |
| Secondary | Duration of Intracranial Response Based on ICR Assessment | From first documentation of CR or PR to documented progression of disease by ICR, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | Duration of intracranial response: time from first documentation of CR or PR considering only lesions having disease site=brain to first documentation of PD or death due to any cause, whichever occurred first, participants who had at least 1 intracranial lesion.CR: disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in \<10mm.PR:\>=30% decrease in the sum of the longest dimensions of target lesions taking reference the baseline sum longest dimension. PD:\>=20% increase in sum of longest dimensions of target lesion, or appearance of one or more new lesion. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm and for non-target lesion PD: unequivocal progression of existing non-target lesion, or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. Kaplan Meier method was used. |
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 | Percentage of Participants With Objective Response (Cohort 1) | From Cycle 1 Day 1 to documented progression of disease by ICR (up to 67 weeks) | The analysis population included all enrolled participants who received at least 1 dose of lorlatinib. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Objective Response (Cohort 1)-Final Analysis | From first dose (Cycle 1 Day 1) to documented disease progression by ICR (up to 271 weeks of treatment exposure) | The safety analysis population included all enrolled participants who received at least 1 dose of lorlatinib. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Response (Cohort 2) | From Cycle 1 Day 1 to documented progression of disease by ICR (up to 67 weeks) | The analysis population included all enrolled participants who received at least 1 dose of loratinib. | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) Based on ICR Assessment | From first dose (Cycle 1 Day 1) to documented PD by ICR, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | The safety analysis population included all enrolled participants who received at least 1 dose of lorlatinib. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival Based on Investigator Assessment | From first dose (Cycle 1 Day 1) to documented progression of disease by investigator, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | The safety analysis population included all enrolled participants who received at least 1 dose of lorlatinib. | Months | MEDIAN |
| SECONDARY | Overall Survival | From first dose (Cycle 1 Day 1) to date of death due to any cause (up to 271 weeks of treatment exposure) | The safety analysis population included all enrolled participants who received at least 1 dose of lorlatinib. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Intracranial Objective Response (IC-OR) Based on ICR Assessment | From first dose (Cycle 1 Day 1) to documented PD by ICR (up to 271 weeks of treatment exposure) | The safety analysis population included all enrolled participants who received at least 1 dose of lorlatinib. Here, 'Overall Number of Participants Analyzed' signifies participants for whom the brain lesions were chosen as RECIST target or non-target lesions at baseline and who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Intracranial Objective Response Based on Investigator Assessment | From first dose (Cycle 1 Day 1) to documented progression of disease by investigator (up to 271 weeks of treatment exposure) | The safety analysis population included all enrolled participants who received at least 1 dose of lorlatinib. Here, 'Overall Number of Participants Analyzed' signifies participants for whom the brain lesions were chosen as RECIST target or non-target lesions at baseline and who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Based on ICR Assessment | From first documentation of CR or PR to documented progression of disease by ICR, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | The safety analysis population included all enrolled participants who received at least 1 dose of lorlatinib. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | DOR Based on Investigator Assessment | From first documentation of CR or PR to documented PD by investigator, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure | The safety analysis population included all enrolled participants who received at least 1 dose of lorlatinib. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure. | Months | MEDIAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group205
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Objective Response (Cohort 1) | Cohort 1 | 70.1 | 95% Confidence Interval 57.7 to 80.7 | Percentage of participants | |
| Percentage of Participants With Objective Response (Cohort 1)-Final Analysis | Cohort 1 | 79.1 | 95% Confidence Interval 67.4 to 88.1 | Percentage of participants | |
| Percentage of Participants With Objective Response (Cohort 2) | Cohort 2 | 47.6 | 95% Confidence Interval 32.0 to 63.6 | Percentage of participants | |
| Progression-Free Survival (PFS) Based on ICR Assessment | Cohort 1 | 26.3 | 95% Confidence Interval 16.6 to NA | Months | |
| Progression-Free Survival (PFS) Based on ICR Assessment | Cohort 2 | 5.6 | 95% Confidence Interval 2.9 to 12.4 | Months | |
| Progression-Free Survival Based on Investigator Assessment | Cohort 1 | 26.3 | 95% Confidence Interval 15.2 to 52.4 | Months | |
| Progression-Free Survival Based on Investigator Assessment | Cohort 2 | 6.9 | 95% Confidence Interval 4.2 to 13.7 | Months | |
| Overall Survival | Cohort 1 | NA | 95% Confidence Interval 42.7 to NA | Months | |
| Overall Survival | Cohort 2 | 21.9 | 95% Confidence Interval 11.9 to 44.1 | Months | |
| Percentage of Participants With Intracranial Objective Response (IC-OR) Based on ICR Assessment | Cohort 1 | 83.8 | 95% Confidence Interval 68.0 to 93.8 | Percentage of participants |
1 to 10 of 205Source ClinicalTrials.gov
See all 205 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 67 | |
| Overall Study | STARTED | Cohort 2 | 42 | |
| Overall Study | COMPLETED | Cohort 1 | 0 | |
| Overall Study | COMPLETED | Cohort 2 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 67 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 42 |
Source ClinicalTrials.gov
Adverse events244
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 | Cohort 1 | 31 | 67 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 | 15 | 42 | |
| other | Atrioventricular block first degree | Cardiac disorders | Cohort 1 | 4 | 67 | |
| other | Atrioventricular block first degree | Cardiac disorders | Cohort 2 | 3 | 42 | |
| other | Sinus bradycardia | Cardiac disorders | Cohort 1 | 6 | 67 | |
| other | Sinus bradycardia | Cardiac disorders | Cohort 2 | 5 | 42 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 1 | 8 | 67 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort 2 | 3 | 42 | |
| other | Ventricular extrasystoles | Cardiac disorders | Cohort 1 | 1 | 67 | |
| other | Ventricular extrasystoles | Cardiac disorders | Cohort 2 | 4 | 42 |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 28 | 67 |
| Total, all-cause mortality | Cohort 2 | 26 | 42 |
| Total, other adverse events | Cohort 1 | 67 | 67 |
| Total, other adverse events | Cohort 2 | 42 | 42 |
| Total, serious adverse events | Cohort 1 | 23 | 67 |
| Total, serious adverse events | Cohort 2 | 16 | 42 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 vs Cohort 2: deaths from any cause | Trial comparisons |
| Cohort 1 vs Cohort 2: 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/NCT03909971
GET https://conductscience.org/api/trials/v1/NCT03909971/registered?page=2