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

Completed Results posted Last updated 11 January 2022

What this trial tests

trial testing Second line (2L) afatinib in Squamous Non-small Cell Lung Cancer in 200 participants. Completed in 18 May 2020.

Timeline

8 May 2020

Primary endpoint
18 May 2020

18 May 2020

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	200
Start date	8 May 2020
Primary completion	18 May 2020
Estimated completion	18 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Second line (2L) afatinib — full drug profile →
• Second line chemotherapy

Conditions studied

• Squamous Non-small Cell Lung Cancer — all drugs for Squamous Non-small Cell Lung Cancer →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Squamous Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Second-line Afatinib Treatment Group	7.3	5.2 – 8.1
Second-line Chemotherapy Treatment Group	4.2	3.9 – 4.9

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

Group	Value	95% CI
Second-line Afatinib Treatment Group With Squamous Cell Histology	5.8	4.4 – 8.0
Second-line Afatinib Treatment Group With Mixed Histology	8.1	5.5 – 9.9

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

Group	Value	95% CI
Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Positive Status	7.4	5.6 – 8.6
Second-line Afatinib Treatment Group With Epidermal Growth Factor Receptor Mutation Negative Status	5.9	4.4 – NA

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

Group	Value	95% CI
Second-line Afatinib Treatment Group	6
Second-line Chemotherapy Treatment Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the start of second-line treatment to the end of follow-up, up to 15 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Second-line Afatinib Treatment Group

Serious: 0

Deaths: 2/99

Other adverse events (5 terms — click to expand)

Reaction	System	Second-line Afatinib Treat…
Diarrhea	Gastrointestinal disorders	—
Skin rash	Skin and subcutaneous tissue disorders	—
Fatigue	General disorders	—
Nausea	Gastrointestinal disorders	—
Stomatitis	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT04552535 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2