Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

• ClinicalTrials.gov Identifier: NCT02695290
• Recruitment Status: Terminated
• First Posted: March 1, 2016
• Results First Posted: September 18, 2017
• Last Update Posted: September 18, 2017
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Carcinoma, Non-Small-Cell Lung; ErbB Receptors
• Intervention: Drug: Afatinib
• Enrollment: 1

Participant Flow

Recruitment Details
Pre-assignment Details	This was an open-label, single-arm Phase IV study of afatinib in patients with stage IV or recurrent Non-Small Cell Lung Cancer who have poor performance status and whose tumors have the common epidermal growth factor receptor (EGFR) mutations, Exon 19 deletions or Exon 21(L858R) substitution mutations.

Arm/Group Title	Afatinib
Arm/Group Description	Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Period Title: Overall Study
Started	1
Completed	1
Not Completed	0

Baseline Characteristics

Arm/Group Title		Afatinib
Arm/Group Description		Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Overall Number of Baseline Participants		1
Baseline Analysis Population Description		Patients who receive at least one dose of afatinib will be included in the treated set. All data collected from the single patient who received study medication.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	1 participants
		62 [1] (NA)
		[1] Not Applicable as only one patient was treated
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1 participants
	Female	0 0.0%
	Male	1 100.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib
Description	Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.
Time Frame	Up to 98 days

Outcome Measure Data

Analysis Population Description

Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication.

Arm/Group Title	Afatinib
Arm/Group Description:	Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Overall Number of Participants Analyzed	1
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Pecentage of Participants
	0.0 [1]; (NA to NA)

[1]

Confidence interval is not calculable as only one patient is analyzed.

2. Secondary Outcome

Title	Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)
Description	Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).
Time Frame	Up to 98 days

Outcome Measure Data

Analysis Population Description

Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication. All data collected from the single patient who received study medication.

Arm/Group Title	Afatinib
Arm/Group Description:	Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Overall Number of Participants Analyzed	1
Measure Type: Number; Unit of Measure: Percentage of Participants
	0

3. Secondary Outcome

Title	Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)
Description	Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.
Time Frame	Up to 98 days

Outcome Measure Data

Analysis Population Description

All data collected from the single patient who received study medication. As none of the AEs led to the dose reduction hence time to first dose reduction is not applicable.

Arm/Group Title	Afatinib
Arm/Group Description:	Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	From first drug administration until 40 days after the last dose of study medication, up to 98 days
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Afatinib
Arm/Group Description	Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.
All-Cause Mortality
	Afatinib
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Afatinib
	Affected / at Risk (%)
Total	0/1 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Afatinib
	Affected / at Risk (%)
Total	1/1 (100.00%)
Gastrointestinal disorders
Diarrhoea † 1	1/1 (100.00%)
Nausea † 1	1/1 (100.00%)
Vomiting † 1	1/1 (100.00%)
General disorders
Fatigue † 1	1/1 (100.00%)
Skin and subcutaneous tissue disorders
Rash † 1	1/1 (100.00%)
Pruritus † 1	1/1 (100.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 19.0

Limitations and Caveats

This study was stopped prematurely when only 1 patient had received afatinib treatment so it was not possible to draw any conclusion.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim
• Phone: 1-800-243-0127
• EMail: clintriage.rdg@boehringer-ingelheim.com

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02695290
• Other Study ID Numbers: 1200.208
• First Submitted: February 25, 2016
• First Posted: March 1, 2016
• Results First Submitted: August 9, 2017
• Results First Posted: September 18, 2017
• Last Update Posted: September 18, 2017