Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Pembrolizumab

Immunomodulating Agents

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Second line (2L) afatinib treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))

Second line (2L) chemotherapy treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))

Second line (2L) afatinib

Second line chemotherapy

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.

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

Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.

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

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 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.

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.

Boehringer Ingelheim

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.

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.

Second-line Afatinib 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.

Second-line Chemotherapy Treatment Group

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Squamous cell only

Mixed histology

Tumor histology

EGFR mutation positive

EGFR mutation negative

Not tested / unknown

Epidermal growth factor receptor (EGFR) mutation status

Never smoked

Current smoker

Former smoker

Smoking history

ECOG 0/1

ECOG ≥ 2

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)

Eastern Cooperative Oncology Group Performance Status at initiation of second line (2L) treatment

Tumor stage I to IIIA

Tumor stage IIIB

Tumor stage IV

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.

Tumor stage at initial diagnosis

Liver

Contralateral lung nodule

Blood and bone marrow

Adrenal gland

Pleura (nodules, effusion)

Intra-abdominal lymph nodes

Brain

Sites of metastatic disease at initiation of second line treatment

Any comorbidity

Hypertension

Chronic pulmonary disease

Cardiovascular disease

Depression

Diabetes without chronic complications

Most common comorbidities at initiation of second line treatment

First line or prior

Second line

Radiation therapy

1 to 49%

>50%

Not tested

Programmed death ligand 1 (PD-L1) expression level

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.

Boehringer Ingelheim, Call Centre

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.

Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment

Patients in the second-line afatinib treatment group with squamous cell histology initiated first-line pembrolizumab and platinum-based combination chemotherapy after 1st June 2018, and subsequently discontinued first-line therapy. All patients with squamous cell histology had started second-line treatment with afatinib at least 3 months prior to the date of data collection.

Second-line Afatinib Treatment Group With Squamous Cell 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.

Second-line Afatinib Treatment Group With Mixed Histology

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.

Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status

Patients in the second-line afatinib treatment group with EGFR mutation positive 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 positive status had started second-line treatment with afatinib at least 3 months prior to the date of data collection.

Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Positive 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.

Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Negative Status

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.

Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status

Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Squamous Non-sm...	Second line (2L... Second line che...	18 Years -	Boehringer Ingelheim
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	Squamous Non-sm...	Second line (2L... Second line che...	18 Years -	Boehringer Ingelheim

Spots Global Cancer Trial Database for second line (2l) afatinib