Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Second line (2L) afatinib | Second line (2L) afatinib treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L)) |
| |
| Second line (2L) chemotherapy | Second line (2L) chemotherapy treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second line (2L) afatinib | Drug | Afatinib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
Diagnosis of squamous or mixed histology non-small cell lung cancer
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 :
Age ≥ 18 years
Exclusion Criteria:
-Received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardinal Health Specialty Solutions | Dublin | Ohio | 43017 | United States |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Second-line Afatinib Treatment Group | Patients in the second-line afatinib treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with afatinib at least 3 months prior to the date of data collection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2019 |
Not provided
Not provided
Not provided
Not provided
| Second line chemotherapy |
| Drug |
Chemotherapy |
|
| 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. | From the start of second-line treatment to the end of follow-up, up to 15 months |
| FG001 |
| Second-line Chemotherapy Treatment Group |
Patients in the second-line chemotherapy treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with any chemotherapy at least 3 months prior to the date of data collection. |
| COMPLETED |
|
| NOT COMPLETED |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Second-line Afatinib Treatment Group | Patients in the second-line afatinib treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with afatinib at least 3 months prior to the date of data collection. |
| BG001 | Second-line Chemotherapy Treatment Group | Patients in the second-line chemotherapy treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with any chemotherapy at least 3 months prior to the date of data collection. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Tumor histology | Count of Participants | Participants |
| ||||||||||||||||
| Epidermal growth factor receptor (EGFR) mutation status | Count of Participants | Participants |
| ||||||||||||||||
| Smoking history | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group Performance Status at initiation of second line (2L) treatment | Eastern Cooperative Oncology Group Performance Status (ECOG PS) is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity) | Count of Participants | Participants |
| |||||||||||||||
| Tumor stage at initial diagnosis | Disease stage means how big tumor is + how far it has spread. They range from 0 (not spread) to IV (spread throughout body). 0 - cancer not spread beyond inner lining of affected organ; I - is small and not spread to lymph nodes (LN); II - spread to some LN near original tumor; III - spread to nearby tissue or spread to far away LN (IIIA: heterogeneous group with diversity of tumor characteristics and varying degrees of LN involvement; IIIB: involves LN on opposite side of chest or above collar bone, or heart or trachea + LN in chest center or near windpipe); IV - has spread to other organs. | Count of Participants | Participants |
| |||||||||||||||
| Sites of metastatic disease at initiation of second line treatment | Count of Participants | Participants |
| ||||||||||||||||
| Most common comorbidities at initiation of second line treatment | Count of Participants | Participants |
| ||||||||||||||||
| Radiation therapy | Count of Participants | Participants |
| ||||||||||||||||
| Programmed death ligand 1 (PD-L1) expression level | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Median | 95% Confidence Interval | months | 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 |
|
|
| ||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Median | 95% Confidence Interval | months | From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients |
| ||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Median | 95% Confidence Interval | months | From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients |
| ||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Count of Participants | Participants | From the start of second-line treatment to the end of follow-up, up to 15 months |
|
From the start of second-line treatment to the end of follow-up, up to 15 months.
Adverse events (AEs) were only collected and reported for 2L afatinib treatment group according to protocol requirements.
All 2L afatinib treatment group 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 (2L) treatment with afatinib at least 3 months prior to date of data collection.
Serious AEs were not collected and reported for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Second-line Afatinib Treatment Group | Patients in the second-line afatinib treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with afatinib at least 3 months prior to the date of data collection. | 2 | 99 | 0 | 0 | 37 | 99 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Skin rash | Skin and subcutaneous tissue disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Jun 16, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mixed histology |
|
| EGFR mutation negative |
|
| Not tested / unknown |
|
| Current smoker |
|
| Former smoker |
|
| ECOG ≥ 2 |
|
| Tumor stage IIIB |
|
| Tumor stage IV |
|
| Contralateral lung nodule |
|
| Blood and bone marrow |
|
| Adrenal gland |
|
| Pleura (nodules, effusion) |
|
| Intra-abdominal lymph nodes |
|
| Brain |
|
| Hypertension |
|
| Chronic pulmonary disease |
|
| Cardiovascular disease |
|
| Depression |
|
| Diabetes without chronic complications |
|
| Second line |
|
| 1 to 49% |
|
| >50% |
|
| Not tested |
|
| OG001 | Second-line Afatinib Treatment Group With Mixed Histology | Patients in the second-line afatinib treatment group with mixed histology initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with mixed histology had started second-line treatment with afatinib at least 3 months prior to the date of data collection. |
|
|
| OG001 | Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Negative Status | Patients in the second-line afatinib treatment group with Epidermal growth factor receptor (EGFR) mutation negative status initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with EGFR mutation negative status had started second-line treatment with afatinib at least 3 months prior to the date of data collection. |
|
|
Patients in the second-line chemotherapy treatment group initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients had started second-line treatment with any chemotherapy at least 3 months prior to the date of data collection. |
|
|