Squamous Non-small Cell Lung CancerNCT04552535

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

An observational study of Squamous Non-small Cell Lung Cancer, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Non-small Cell Lung Cancer
What is being tested?: Second line (2L) afatinib and Second line chemotherapy
How many people: 200 participants
Where: 1 siteUnited States
Study dates: 8 May 2020to 18 May 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

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)
First cycle of pembrolizumab received after 06/01/2018
Permanently discontinued 1L pembrolizumab treatment
Initiated second-line treatment at least 3 months prior to the date of data collection, with either :
Afatinib
Any chemotherapy
Age ≥ 18 years

Who cannot join

-Received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial

Trial locations and contacts

1 site in 1 country.

United States1 site

Cardinal Health Specialty Solutions
Dublin, Ohio, 43017

Other trials in United States

About this study

Official title: 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.

Conditions: Squamous Non-small Cell Lung Cancer
Being tested: Second line (2L) afatinib, Second line chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Second line (2L) afatinibDrug
Afatinib
Second line chemotherapyDrug
Chemotherapy

Study groups in NCT04552535
Study group	Role	What they receive
Second line (2L) afatinib		Second line (2L) afatinib treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L)) Receives: Drug: Second line (2L) afatinib
Second line (2L) chemotherapy		Second line (2L) chemotherapy treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L)) Receives: Drug: Second line chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the start of second-line treatment to the end of follow-up, up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 202018 May 2020

First posted17 Sep 2020
Study start8 May 2020
Primary completion18 May 2020
Study completion18 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04552535
Sponsor's protocol ID: 1200-0325
Status last verified: Dec 2021
First submitted: 10 Sep 2020
Last updated: 11 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
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All Squamous Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT04552535
Acronym / sponsor ID: 1200-0325
Conditions: Squamous Non-small Cell Lung Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 8 May 2020 (actual)
Primary completion: 18 May 2020 (actual)
Study completion: 18 May 2020 (actual)
First posted: 17 Sep 2020 (actual)
Results: Posted 8 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Second line (2L) afatinib	–	Drug: Second line (2L) afatinibSecond line (2L) afatinib treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))
Second line (2L) chemotherapy	–	Drug: Second line chemotherapySecond line (2L) chemotherapy treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (8 listed)

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

Key exclusion criteria (1 listed)

-Received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Second line (2L) afatinibAfatinib	Drug	Second line (2L) afatinib
Second line chemotherapyChemotherapy	Drug	Second line (2L) chemotherapy

Primary outcome

Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) 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 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 With Afatinib During Second Line (2L) Treatment Defined by Histology Status
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 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 on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status
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 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.
Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment
Time frame: 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.

Results and safety

Results posted to the registry on 8 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Second-line Afatinib Treatment Group	99	99
Second-line Chemotherapy Treatment Group	101	101

Primary outcome: Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) 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. Median (95% Confidence Interval). Unit: months

Measure	Second-line Afatinib Treatment Group n = 99	Second-line Chemotherapy Treatment Group n = 101
Value	7.3 (5.2 to 8.1)	4.2 (3.9 to 4.9)

Population analysed: 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.

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

Time frame: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients. Median (95% Confidence Interval). Unit: months

Measure	Second-line Afatinib Treatment Group With Squamous Cell Histology n = 64	Second-line Afatinib Treatment Group With Mixed Histology n = 35
Value	5.8 (4.4 to 8.0)	8.1 (5.5 to 9.9)

Population analysed: 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.

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

Time frame: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients. Median (95% Confidence Interval). Unit: months

Measure	Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Positive Status n = 39	Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Negative Status n = 28
Value	7.4 (5.6 to 8.6)	5.9 (4.4 to NA)

Population analysed: 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.

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

Time frame: From the start of second-line treatment to the end of follow-up, up to 15 months. Count of participants. Unit: Participants

Measure	Second-line Afatinib Treatment Group n = 99	Second-line Chemotherapy Treatment Group n = 101
Value	6	0

Adverse events

Time frame: From the start of second-line treatment to the end of follow-up, up to 15 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Second-line Afatinib Treatment Group	0 of 0	37 of 99 (37.4%)	2 of 99

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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

Related trials for Squamous Non-small Cell Lung Cancer

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Squamous Non-small Cell Lung Cancer, run by Boehringer Ingelheim at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04552535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.