Trial · NCT04552535
A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung
NCT04552535, Completed, Boehringer Ingelheim; results first posted 2021-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung. Trials, record NCT04552535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04552535
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung
- NCT number
- NCT04552535
- Status
- Completed
- Enrollment
- 200 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Squamous Non-small Cell Lung Cancer
- Interventions
- Second line (2L) afatinib, Second line chemotherapy
- First posted
- 2020-09-17
- Last updated
- 2022-01-11
- Results first posted
- 2021-07-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment | From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated and up to 7.5 months for chemotherapy treated patients | Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment. |
| Primary | Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status | From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients | Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment. Patients treated with afatinib were analysed for their histology status and categorized into a squamous cell - or mixed histology treatment group. |
| Primary | Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status | From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients | Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment. |
| Primary | Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment | From the start of second-line treatment to the end of follow-up, up to 15 months | Chart abstractors (i.e. the patients treating physician) were asked to abstract information regarding severe (grade 3 or higher) irAEs of specific interest (including pneumonitis, colitis, hepatitis, interstitial lung disease, higher indeterminate pulmonary events, death, or discontinuation of therapy due to toxicity) during first line (1L) treatment and second line (2L) for both patients treated with afatinib in 2L and those treated with chemotherapy in 2L. Providers/abstractors were asked only if these specific immune related events occurred. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment | From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated and up to 7.5 months for chemotherapy treated patients | All patients (pts) who initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy and had started second-line treatment with either afatinib or any CT at least 3 months prior to date of data collection. | months | MEDIAN |
| PRIMARY | Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status | From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients | All patients (pts) who initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy and had started second-line treatment with afatinib at least 3 months prior to date of data collection. Only patients treated with afatinib and with squamous cell - or mixed histology were included in the analysis. | months | MEDIAN |
| PRIMARY | Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status | From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients | All patients (pts) who initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy and had started second-line treatment with afatinib at least 3 months prior to date of data collection. Only afatinib treated patients with an EGFR mutation positive or negative status were included in the analysis. | months | MEDIAN |
| PRIMARY | Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment | From the start of second-line treatment to the end of follow-up, up to 15 months | All patients (pts) who initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy and had started second-line treatment with either afatinib or any CT at least 3 months prior to date of data collection. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment | Second-line Afatinib Treatment Group | 7.3 | 95% Confidence Interval 5.2 to 8.1 | months | |
| Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment | Second-line Chemotherapy Treatment Group | 4.2 | 95% Confidence Interval 3.9 to 4.9 | months | |
| Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status | Second-line Afatinib Treatment Group With Squamous Cell Histology | 5.8 | 95% Confidence Interval 4.4 to 8.0 | months | |
| Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status | Second-line Afatinib Treatment Group With Mixed Histology | 8.1 | 95% Confidence Interval 5.5 to 9.9 | months | |
| Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status | Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Positive Status | 7.4 | 95% Confidence Interval 5.6 to 8.6 | months | |
| Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status | Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Negative Status | 5.9 | 95% Confidence Interval 4.4 to NA | months | |
| Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment | Second-line Afatinib Treatment Group | 6 | Participants | ||
| Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment | Second-line Chemotherapy Treatment Group | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Second-line Afatinib Treatment Group | 99 | |
| Overall Study | STARTED | Second-line Chemotherapy Treatment Group | 101 | |
| Overall Study | COMPLETED | Second-line Afatinib Treatment Group | 99 | |
| Overall Study | COMPLETED | Second-line Chemotherapy Treatment Group | 101 | |
| Overall Study | NOT COMPLETED | Second-line Afatinib Treatment Group | 0 | |
| Overall Study | NOT COMPLETED | Second-line Chemotherapy Treatment Group | 0 |
Source ClinicalTrials.gov
Adverse events5
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 | Diarrhea | Gastrointestinal disorders | Second-line Afatinib Treatment Group | 26 | 99 | |
| other | Skin rash | Skin and subcutaneous tissue disorders | Second-line Afatinib Treatment Group | 6 | 99 | |
| other | Fatigue | General disorders | Second-line Afatinib Treatment Group | 5 | 99 | |
| other | Nausea | Gastrointestinal disorders | Second-line Afatinib Treatment Group | 5 | 99 | |
| other | Stomatitis | Gastrointestinal disorders | Second-line Afatinib Treatment Group | 5 | 99 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Second-line Afatinib Treatment Group | 2 | 99 |
| Total, other adverse events | Second-line Afatinib Treatment Group | 37 | 99 |
| Total, serious adverse events | Second-line Afatinib Treatment Group | 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 |
|---|
| Second-line Afatinib Treatment Group vs Second-line Chemotherapy Treatment Group: Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment |
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.
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/NCT04552535
GET https://conductscience.org/api/trials/v1/NCT04552535/registered