Trial · NCT05834348
A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.
NCT05834348, Completed, Pfizer; results first posted 2025-03-30
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. Trials, record NCT05834348. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05834348
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.
- NCT number
- NCT05834348
- Status
- Completed
- Enrollment
- 5,279 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
lorlatinib, crizotinib, brigatinib, ceritinib, alectinib, atezolizumab, bevacizumab, paclitaxel, carboplatin, docetaxel, erlotinib, gefitinib, afatinib, dacomitinib, osimertinib, pembrolizumab, nivolumab, entrectinib
- First posted
- 2023-04-28
- Last updated
- 2025-03-30
- Results first posted
- 2025-03-30
- Limitations and caveats
- The observation period was changed from 1-Jan-2009 to 1-Jan-2015 based on sponsor decision as only a few participants with uncertain about the data quality were recorded prior 2015.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Treatment of Anti-cancer Drugs | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | The duration of treatment of anti-cancer drugs was calculated as median time to treatment (mToT) for first line treatment and the median total ToT for all treatment lines (mTToT) for the anticancer therapies for EGFR+, ALK+ and ROS1+ and was presented in this outcome measure. mToT measured the time on the treatment participants receive as first line treatment, measuring the time from they start the treatment until they stop the first line treatment (or end of follow up), using the Kaplan Meier estimator. mTToT measured the time on all treatment - from the time they start first line treatment, until the point they stop their last treatment line (or end of follow up), using the Kaplan Meier estimator. |
| Primary | Number of Participants Classified According to Treatments of Anti-cancer Drugs | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Number of participants were classified and reported according to the Anti-cancer drugs received during first-line, second-line and third-line treatment after diagnosis of NSCLC. |
| Primary | Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Number of participants were classified and reported according to the treatment lines received including first-line, second-line and third-line treatment after diagnosis of NSCLC. |
| Primary | Overall Survival (OS) | From treatment initiation (1-Jan-2015) to date of death (until 31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | OS was defined as time from treatment initiation of anticancer therapy to date of death due to any cause. Analysis was performed by Kaplan-Meier method. |
| Secondary | Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis | At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study | The percentage of participants classified according to the disease stages as 3B, 3C, 4A and 4B at the time of diagnosis were reported in this outcome measure. Cancer stages were classified based on tumor size (T), metastasis to nearby lymph nodes (LN) \[N\] and distant metastasis (M). Stages were 3B, 3C, 4A and 4B. Stage 3B (T1N3M0, T2N3M0, T3N3M0 and T4N2M0). Stage 3C (T3N3M0, T4N3M0), Stage 4A (anyT, anyM and M1a/M1b), Stage 4B (anyT, anyM and M1c). where T1=\<3 cm; T2= 3 to \<5 cm; T3= 5 to \<7 cm; T4= \>7cm. N0=not spread to LN; N1=spread to 1 to 3; N2=spread to 4 to 9; N3=spread \>10 axillary LN. M0= no metastasis; M1a= cancer has spread to other lung; M1b= cancer has as a single tumor outside of the chest, such as to a distant lymph node or an organ such as the liver, bones, or brain; M1c= cancer has spread as more than one tumor outside the chest, such as to distant lymph nodes and/or to other organs such as the liver, bones, or brain. |
| Secondary | Percentage of Participants Classified According to the NSCLC Histopathological Subtype | At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study | Percentage of participants classified according to the NSCLC histopathological subtype viz adenocarcinoma, non-small cell carcinoma, large cell neuroendocrine carcinoma were reported in this outcome measure. |
| Secondary | Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Number of participants classified according to the selected administered non-cancer drugs (anticoagulants and statins) were reported in this outcome measure. |
| Secondary | Number of Packs Dispensed at the Time of Dispensing | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Number of packs dispensed to participants at the time of dispensing were reported in this outcome measure. |
| Secondary | Number of Participants Classified as Per Specific Norwegian Health Regions | At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study | Number of participants classified according to the Norwegian health regions were reported in this outcome measure. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Treatment of Anti-cancer Drugs | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified rows. | Months | MEDIAN |
| PRIMARY | Number of Participants Classified According to Treatments of Anti-cancer Drugs | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure; Number Analyzed signifies participants evaluable for specified rows. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number Analyzed signifies number evaluable for specified rows. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Survival (OS) | From treatment initiation (1-Jan-2015) to date of death (until 31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number Analyzed signifies number evaluable for specified rows. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis | At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Classified According to the NSCLC Histopathological Subtype | At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Packs Dispensed at the Time of Dispensing | From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, Number of Participants Analyzed signifies participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified rows. All participants under Number of Participants Analyzed contributed data to the table but may not have evaluable data for every row. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Classified as Per Specific Norwegian Health Regions | At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study | Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group233
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | EGFR+ participants receiving osimertinib: mToT | 11 | 95% Confidence Interval 10.1 to NA | Months |
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | EGFR+ participants receiving osimertinib: mTToT | 14 | 95% Confidence Interval 11.1 to NA | Months |
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | EGFR+ participants receiving other TKI: mToT | 9.4 | 95% Confidence Interval 8.2 to 11.2 | Months |
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | EGFR+ participants receiving other TKI: mTToT | 15.8 | 95% Confidence Interval 13.7 to 18.1 | Months |
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | ALK+ participants receiving alectinib: mToT | 20 | 95% Confidence Interval 14.7 to 23.7 | Months |
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | ALK+ participants receiving alectinib: mTToT | 28 | 95% Confidence Interval 18 to NA | Months |
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | ALK+ participants receiving brigatinib: mToT | 11 | 95% Confidence Interval 4.7 to NA | Months |
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | ALK+ participants receiving brigatinib: mTToT | 16 | 95% Confidence Interval 11.1 to NA | Months |
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | ALK+ participants receiving crizotinib: mToT | 7 | 95% Confidence Interval 2.9 to 21.6 | Months |
| Duration of Treatment of Anti-cancer Drugs | Biomarker Cohort | ALK+ participants receiving crizotinib: mTToT | 19 | 95% Confidence Interval 10.5 to 37.0 | Months |
1 to 10 of 233Source ClinicalTrials.gov
See all 233 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Biomarker Cohort | 618 | |
| Overall Study | STARTED | Non-biomarker Cohort | 4,661 | |
| Overall Study | COMPLETED | Biomarker Cohort | 618 | |
| Overall Study | COMPLETED | Non-biomarker Cohort | 4,661 | |
| Overall Study | NOT COMPLETED | Biomarker Cohort | 0 | |
| Overall Study | NOT COMPLETED | Non-biomarker Cohort | 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 | Biomarker Cohort | 364 | 618 |
| Total, all-cause mortality | Non-biomarker Cohort | 3,780 | 4,661 |
| Total, other adverse events | Biomarker Cohort | 0 | 0 |
| Total, other adverse events | Non-biomarker Cohort | 0 | 0 |
| Total, serious adverse events | Biomarker Cohort | 0 | 0 |
| Total, serious adverse events | Non-biomarker Cohort | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Biomarker Cohort vs Non-biomarker Cohort: deaths from any cause |
Source 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT05834348
GET https://conductscience.org/api/trials/v1/NCT05834348/results?page=2