Trial · NCT04647110
Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.
NCT04647110, Completed, Pfizer; results first posted 2022-07-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers. Trials, record NCT04647110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04647110
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.
- NCT number
- NCT04647110
- Status
- Completed
- Enrollment
- 549 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- ALK-positive NSCLC
- Interventions
- crizotinib, alectinib, brigatinib, ceritinib, lorlatinib
- First posted
- 2020-11-30
- Last updated
- 2023-04-06
- Results first posted
- 2022-07-13
- Limitations and caveats
- Due to ethical compliance study team ensured results would not be reported for those cohorts/groups which had less than 5 participants at the index date.
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS): Based on Treatment Cohort Groups | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI. |
| Primary | Overall Survival: Based on Chemotherapy Status | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. Results were reported based on chemotherapy status. |
| Primary | Overall Survival: Based on Central Nervous System (CNS) Metastases Status | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, participants were grouped on basis of their CNS-metastases status. |
| Primary | Overall Survival: Based on ALK Sequencing, 1 Line of ALK TKI Treatment | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, OS was reported for participants who received 1 line of ALK TKI treatment. Reporting arms were based on type of ALK TKI, with or without chemotherapy. ALK TKIs considered were crizotinib, alectinib, ceritinib. |
| Primary | Overall Survival: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure OS was reported for participants who received 2 lines of ALK TKI treatment. Reporting arms were based on type of first line ALK TKI treatment and second line of ALK TKI treatment, with or without chemotherapy. |
| Primary | Overall Survival: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure OS was reported for participants who received 3 lines of ALK inhibitor treatment. Reporting arms were based on type of first line ALK TKI treatment, second line of ALK TKI treatment and third line of ALK TKI treatment with or without, chemotherapy. |
| Primary | Overall Survival: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | OS was defined as the time from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data). Kaplan-Meier method was used for analysis. In this outcome measure, OS was reported for participants who received \>=4 lines of ALK inhibitor treatment with or without chemotherapy. |
| Primary | Percentage of Participants Alive After 5 Years From Index Date: Based on Treatment Cohort Groups | 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Results were reported for treatment cohort groups based on generation of ALK treatment and were as following: Group A1 = chemotherapy + crizotinib (first generation ALK TKI) + any second (2nd) generation ALK TKI; Group A2 = crizotinib + any 2nd generation ALK TKI; Group B1: chemotherapy + crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group B2 = crizotinib + any 2nd generation ALK TKI + any other 2nd generation ALK TKI; Group C1 = chemotherapy + crizotinib + any 2nd generation ALK TKI + lorlatinib (third generation ALK TKI); Group C2: crizotinib + any 2nd generation ALK TKI + lorlatinib and Group D1 = any 2nd generation ALK TKI + any other 2nd generation ALK TKI. |
| Primary | Percentage of Participants Alive After 5 Years From Index Date: Based on Chemotherapy Status | 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on chemotherapy status. |
| Primary | Percentage of Participants Alive After 5 Years From Index Date: Based on CNS Metastases Status | 5 years post index date during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Participants alive after five years from index date (date of first ALK TKI prescription) to the date of death due to any cause or censoring date (latest available date in data), were reported in this outcome measure. Results were reported based on CNS metastases status. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Duration of Treatment: Based on Treatment Cohort Groups | From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure based on generation of ALK treatment. | Years | MEAN |
| SECONDARY | Duration of Treatment: Based on Chemotherapy Status | From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. | Years | MEAN |
| SECONDARY | Duration of Treatment: Based on ALK Sequencing, 1 Line of ALK TKI Treatment | From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, Overall Number of Participants Analyzed (N) signifies participants evaluable for this measure and received only 1 line of ALK TKIs with/ without chemotherapy. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had \<5 participants at the index date. | Years | MEAN |
| SECONDARY | Duration of Treatment: Based on ALK Sequencing, 2 Lines of ALK TKI Treatment | From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Overall Number of Participants Analyzed (N): participants evaluable for this measure and received only 2 lines of ALK TKIs with/ without chemotherapy. Groups with N =0: no participants with respective ALK TKI sequencing. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had \<5 participants at the index date. | Years | MEAN |
| SECONDARY | Duration of Treatment: Based on ALK Sequencing, 3 Lines of ALK TKI Treatment | From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Overall Number of Participants Analyzed (N): participants evaluable for this measure and received only 3 lines of ALK TKIs with/ without chemotherapy. Groups with N =0: no participants with respective ALK TKI sequencing. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had \<5 participants at the index date. | Years | MEAN |
| SECONDARY | Duration of Treatment: Based on ALK Sequencing, More Than or Equal to (>=) 4 Lines of ALK TKI Treatment | From index date to treatment completion/discontinuation during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and received \>= 4 lines of ALK TKI treatment with or without chemotherapy. | Years | MEAN |
| PRIMARY | Overall Survival (OS): Based on Treatment Cohort Groups | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure based on generation of ALK treatment. | Years | MEDIAN |
| PRIMARY | Overall Survival: Based on Chemotherapy Status | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. | Years | MEDIAN |
| PRIMARY | Overall Survival: Based on Central Nervous System (CNS) Metastases Status | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. | Years | MEDIAN |
| PRIMARY | Overall Survival: Based on ALK Sequencing, 1 Line of ALK TKI Treatment | From index date to the date of death due to any cause or censoring date, during data identification period of 9 years (retrieved data assessed in this observational study for approximately 3 months) | Analysis population included all eligible participants whose data were retrieved from Swedish administrative registers and assessed. Here, Overall Number of Participants Analyzed (N) signifies participants evaluable for this measure and received only 1 line of ALK TKIs with/ without chemotherapy. Due to ethical compliance, it was pre-planned not to report data for those reporting groups which had \<5 participants at the index date. | Years | MEDIAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group204
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Treatment: Based on Treatment Cohort Groups | Group A1 | 1.66 | Standard Deviation 1.28 | Years | |
| Duration of Treatment: Based on Treatment Cohort Groups | Group A2 | 1.86 | Standard Deviation 1.31 | Years | |
| Duration of Treatment: Based on Treatment Cohort Groups | Group B1 | 3.37 | Standard Deviation 1.24 | Years | |
| Duration of Treatment: Based on Treatment Cohort Groups | Group B2 | 2.45 | Standard Deviation 1.53 | Years | |
| Duration of Treatment: Based on Treatment Cohort Groups | Group C1 | 2.56 | Standard Deviation 1.42 | Years | |
| Duration of Treatment: Based on Treatment Cohort Groups | Group C2 | 2.72 | Standard Deviation 1.03 | Years | |
| Duration of Treatment: Based on Treatment Cohort Groups | Group D1 | 1.36 | Standard Deviation 0.75 | Years | |
| Duration of Treatment: Based on Chemotherapy Status | Participants With No First Line Chemotherapy | 1.23 | Standard Deviation 1.28 | Years | |
| Duration of Treatment: Based on Chemotherapy Status | Participants With First Line Chemotherapy | 1.07 | Standard Deviation 1.28 | Years | |
| Duration of Treatment: Based on ALK Sequencing, 1 Line of ALK TKI Treatment | Crizotinib | First Line ALK TKI Treatment Duration | 0.72 | Standard Deviation 1.19 | Years |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With No First Line Chemotherapy | 345 | |
| Overall Study | STARTED | Participants With First Line Chemotherapy | 204 | |
| Overall Study | COMPLETED | Participants With No First Line Chemotherapy | 345 | |
| Overall Study | COMPLETED | Participants With First Line Chemotherapy | 204 | |
| Overall Study | NOT COMPLETED | Participants With No First Line Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Participants With First Line Chemotherapy | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With No First Line Chemotherapy | 0 | 0 |
| Total, all-cause mortality | Participants With First Line Chemotherapy | 0 | 0 |
| Total, other adverse events | Participants With No First Line Chemotherapy | 0 | 0 |
| Total, other adverse events | Participants With First Line Chemotherapy | 0 | 0 |
| Total, serious adverse events | Participants With No First Line Chemotherapy | 0 | 0 |
| Total, serious adverse events | Participants With First Line Chemotherapy | 0 | 0 |
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.
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/NCT04647110
GET https://conductscience.org/api/trials/v1/NCT04647110/registered?page=2