An observational study in Squamous Non-small Cell Lung Cancer, sponsored by Boehringer Ingelheim. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Boehringer Ingelheim · Observational
This study aims to characterize the profile and outcomes for patients with Squamous Cell Carcinoma of the Lung (SqCC) who progress on 1L pembrolizumab in combination with platinum based chemotherapy and receive afatinib as second line (2L) therapy.
1,772 studies on the registry are indexed under Carcinoma, Squamous Cell; 412 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 268 observational studies indexed under Carcinoma, Squamous Cell.
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Patients with metastatic Squamous cell carcinoma (SqCC) of the lung treated with pembrolizumab in combination with platinum doublet chemotherapy as first line (1L) treatment followed by either afatinib as second line (2L) treatment or chemotherapy as 2L treatment.
Treated with pembrolizumab in combination with platinum-based chemotherapy as initial therapy for advanced or metastatic disease (stage IIIB or IV)
Initiated second-line treatment at least 3 months prior to the date of data collection, with either :
Exclusion Criteria:
-Received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial
Second line (2L) afatinib treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))
Drug: Second line (2L) afatinib
Second line (2L) chemotherapy treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))
Drug: Second line chemotherapy
Afatinib
Chemotherapy
Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment
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.
Time frame: 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 With Afatinib During Second Line (2L) Treatment Defined by Histology Status
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.
Time frame: 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 With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status
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.
Time frame: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients
Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment
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.
Time frame: From the start of second-line treatment to the end of follow-up, up to 15 months
This retrospective, non-interventional, multi-site cohort study utilized existing data from the electronic medical records of patients with advanced or metastatic Squamous Cell Carcinoma (SqCC) of the lung treated with first-line pembrolizumab in combination with platinum-doublet chemotherapy, followed by second-line afatinib or chemotherapy.
| Milestone | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group |
|---|---|---|
| Started | 99 | 101 |
| Completed | 99 | 101 |
| Not completed | 0 | 0 |
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.
| months | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group |
|---|---|---|
| Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment | 7.3 (5.2 to 8.1) | 4.2 (3.9 to 4.9) |
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.
| months | Second-line Afatinib Treatment Group With Squamous Cell Histology | Second-line Afatinib Treatment Group With Mixed Histology |
|---|---|---|
| Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status | 5.8 (4.4 to 8.0) | 8.1 (5.5 to 9.9) |
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.
| months | Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Positive Status | Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Negative Status |
|---|---|---|
| Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status | 7.4 (5.6 to 8.6) | 5.9 (4.4 to NA) |
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.
| Participants | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group |
|---|---|---|
| Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment | 6 | 0 |
Collected over From the start of second-line treatment to the end of follow-up, up to 15 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Second-line Afatinib Treatment Group | 2/99 (2%) | — | 37/99 (37.4%) |
| Event | Second-line Afatinib Treatment Group |
|---|---|
| DiarrheaGastrointestinal disorders | 26/99 |
| Skin rashSkin and subcutaneous tissue disorders | 6/99 |
| FatigueGeneral disorders | 5/99 |
| NauseaGastrointestinal disorders | 5/99 |
| StomatitisGastrointestinal disorders | 5/99 |
All patients (pts) aged ≥18 years, initiated first-line (1L) pembrolizumab and platinum-based combination chemotherapy (CT) after 1st June 2018, and subsequently discontinued 1L therapy. All pts had started second-line treatment with either afatinib or any CT at least 3 months prior to date of data collection. Maximum follow-up for any pts was approx 15 months. Pts were excluded if they had received pembrolizumab in combination with platinum-based CT as part of an interventional clinical trial.
| Age, Continuous(Years) | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group | Total |
|---|---|---|---|
| Median | 67 (60 to 71) | 66 (61 to 70) | 67 (61 to 72) |
| Sex: Female, Male(Participants) | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group | Total |
|---|---|---|---|
| Female | 43 | 34 | 77 |
| Male | 56 | 67 | 123 |
| Race (NIH/OMB)(Participants) | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 1 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 30 | 23 | 53 |
| White | 59 | 73 | 132 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 4 | 8 |
| Tumor histology(Participants) | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group | Total |
|---|---|---|---|
| Squamous cell only | 64 | 98 | 162 |
| Mixed histology | 35 | 3 | 38 |
| Epidermal growth factor receptor (EGFR) mutation status(Participants) | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group | Total |
|---|---|---|---|
| EGFR mutation positive | 39 | 5 | 44 |
| EGFR mutation negative | 28 | 33 | 61 |
| Not tested / unknown | 32 | 63 | 95 |
| Smoking history(Participants) | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group | Total |
|---|---|---|---|
| Never smoked | 12 | 0 | 12 |
| Current smoker | 16 | 19 | 35 |
| Former smoker | 71 | 82 | 153 |
| Eastern Cooperative Oncology Group Performance Status at initiation of second line (2L) treatment(Participants) | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group | Total |
|---|---|---|---|
| ECOG 0/1 | 45 | 50 | 95 |
| ECOG ≥ 2 | 54 | 51 | 105 |
| Tumor stage at initial diagnosis(Participants) | Second-line Afatinib Treatment Group | Second-line Chemotherapy Treatment Group | Total |
|---|---|---|---|
| Tumor stage I to IIIA | 13 | 8 | 21 |
| Tumor stage IIIB | 7 | 3 | 10 |
| Tumor stage IV | 79 | 90 | 169 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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