Trial Outcomes & Findings for LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures (NCT NCT01271725)

Last Updated: 2019-06-17

Results Overview

Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

Results posted on

2019-06-17

Participant Flow

An open-label, multinational, phase-II trial of Afatinib (BIBW 2992) in patients with metastatic human epidermal growth factor receptor (HER2) - overexpressing breast cancer failing HER2 - targeted treatment in the neoadjuvant and/or adjuvant treatment setting

All subjects were screened for eligibility. It was not planned to compare efficacy of the combination therapies "Afatinib and Paclitaxel or Afatinib and Vinorelbine" as the study was stopped prematurely and the patient number in both treatment groups is not significant. However, for safety reporting both combination therapy are reported separately

Participant milestones

Participant milestones
Measure	Afatinib Monotherapy Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Part A STARTED	74	0
Part A COMPLETED	39	0
Part A NOT COMPLETED	35	0
Part B STARTED	0	39
Part B COMPLETED	0	27
Part B NOT COMPLETED	0	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Afatinib Monotherapy Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Part A Progressive disease according to RECIST	8	0
Part A Clinical signs/symptoms of progression	2	0
Part A Other Adverse Event	8	0
Part A Lost to Follow-up	1	0
Part A Withdrawal by Subject	12	0
Part A Other than specified	3	0
Part A Protocol Violation	1	0
Part B Other than specified	0	2
Part B Clinical signs/symptoms of progression	0	2
Part B Other Adverse Event	0	1
Part B Protocol Violation	0	1
Part B Withdrawal by Subject	0	6

Baseline Characteristics

LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.
Age, Continuous	51.3 Years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	47 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

Population: The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. Treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel or of afatinib and vinorelbine. It was not planned to compare between the two types of combination therapies hence arm is combined

Outcome measures

Outcome measures
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy n=39 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy	Afatinib and Paclitaxel Combination Therapy Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1	18 Percentage of participants Interval 10.0 to 28.0	31 Percentage of participants Interval 17.0 to 48.0	—

SECONDARY outcome

Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Outcome measures

Outcome measures
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy n=39 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy	Afatinib and Paclitaxel Combination Therapy Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Best Overall Response According to RECIST v1.1 (With Confirmation) Complete response (CR)	1 Percentage of participants Interval 0.0 to 7.0	0 Percentage of participants Interval 0.0 to 9.0	—
Best Overall Response According to RECIST v1.1 (With Confirmation) Partial response (PR)	16 Percentage of participants Interval 9.0 to 27.0	31 Percentage of participants Interval 17.0 to 48.0	—
Best Overall Response According to RECIST v1.1 (With Confirmation) Stable disease (SD)	45 Percentage of participants Interval 33.0 to 57.0	46 Percentage of participants Interval 30.0 to 63.0	—
Best Overall Response According to RECIST v1.1 (With Confirmation) Progressive disease	28 Percentage of participants Interval 19.0 to 40.0	10 Percentage of participants Interval 3.0 to 24.0	—
Best Overall Response According to RECIST v1.1 (With Confirmation) Not evaluable	9 Percentage of participants Interval 4.0 to 19.0	13 Percentage of participants Interval 4.0 to 27.0	—

SECONDARY outcome

Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part (without clinical disease assessment) .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Outcome measures

Outcome measures
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy n=39 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy	Afatinib and Paclitaxel Combination Therapy Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation) Complete response (CR)	1 Percentage of participants Interval 0.0 to 7.0	0 Percentage of participants Interval 0.0 to 9.0	—
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation) Partial response (PR)	19 Percentage of participants Interval 11.0 to 30.0	44 Percentage of participants Interval 28.0 to 60.0	—
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation) Stable disease (SD)	42 Percentage of participants Interval 31.0 to 54.0	33 Percentage of participants Interval 19.0 to 50.0	—
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation) Progressive disease	28 Percentage of participants Interval 19.0 to 40.0	10 Percentage of participants Interval 3.0 to 24.0	—
Best Overall Response According to RECIST v1.1 (Regardless of Confirmation) Not evaluable	9 Percentage of participants Interval 4.0 to 19.0	13 Percentage of participants Interval 4.0 to 27.0	—

SECONDARY outcome

Timeframe: From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression

Progression Free Survival is defined as the time from the drug start date to the date of 1st disease progression or death for monotherapy and 2nd disease progression or death from the drug start date of the combination therapy for combination therapy'. Median is calculated from the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy n=39 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy	Afatinib and Paclitaxel Combination Therapy Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Progression Free Survival (PFS)	86.0 Days Interval 72.0 to 127.0	135.0 Days Interval 95.0 to 224.0	—

SECONDARY outcome

Timeframe: From the first objective response to the time of progression or death, up to 1562 days

Duration of objective response, defined as the time from first objective response to the time of progression or death. (regardless of confirmation). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Outcome measures

Outcome measures
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy n=39 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy	Afatinib and Paclitaxel Combination Therapy Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Duration of Objective Response According to RECIST v1.1	168.5 Days Interval 85.0 to 253.0	125.0 Days Interval 73.0 to 505.0	—

SECONDARY outcome

Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

Population: The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. The treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel, or of afatinib and vinorelbine.

Percentage of patients with highest common terminology criteria for adverse events (CTCAE) version 3.0 Grade of 3 or higher.

Outcome measures

Outcome measures
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy n=13 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy	Afatinib and Paclitaxel Combination Therapy n=26 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher	43 Percentage of participants	62 Percentage of participants	65 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and End of treatment period, up to 1562 days

Change from baseline to end of treatment in systolic blood pressure (SBP).

Outcome measures

Outcome measures
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy n=13 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy	Afatinib and Paclitaxel Combination Therapy n=26 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)	-1.2 Millimeter of mercury (mmHg) Standard Deviation 17.9	-1.0 Millimeter of mercury (mmHg) Standard Deviation 15.1	-3.7 Millimeter of mercury (mmHg) Standard Deviation 12.1

SECONDARY outcome

Timeframe: Baseline and End of treatment period, up to 1562 days

Change from baseline to end of treatment in diastolic blood pressure (DBP).

Outcome measures

Outcome measures
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy n=13 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy	Afatinib and Paclitaxel Combination Therapy n=26 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)	-1.8 Millimeter of mercury (mmHg) Standard Deviation 12.0	1.9 Millimeter of mercury (mmHg) Standard Deviation 10.7	-1.6 Millimeter of mercury (mmHg) Standard Deviation 10.0

SECONDARY outcome

Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

Population: The treated set for monotherapy comprised all patients who received at least 1 dose of afatinib. Number Analyzed are the patients with no possible clinically significant abnormality at baseline. Treated set for combination therapy comprised all patients who received at least 1 dose of each of afatinib and paclitaxel, or of afatinib and vinorelbine.

Number of patient with possibly clinically significant (PCS) laboratory values by functional group (haematology, differentials, coagulation, electrolytes, enzymes, and substrates). Acronyms Used: Prothrombin time-International normalized ratio (PT-INR), Alanine aminotransferase/Glutamic pyruvic transaminase (ALT/GPT) Serum glutamic pyruvic transaminase (SGPT), Aspartate aminotransferase/Glutamic-oxaloacetic transaminase (AST/GOT) Serum glutamic-oxaloacetic transaminase (SGOT)

Outcome measures

Outcome measures
Measure	Afatinib Monotherapy n=74 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.	Afatinib and Paclitaxel or Vinorelbine Combination Therapy n=13 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy	Afatinib and Paclitaxel Combination Therapy n=26 Participants Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Haematology - Haemoglobin (low)	9 Participants	5 Participants	17 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Haematology - White blood cell count (low)	5 Participants	9 Participants	13 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Haematology - Platelets (low)	2 Participants	0 Participants	1 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Differentials, automatic - Neutrophils (low)	1 Participants	10 Participants	12 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Coagulation - PT-INR (high)	1 Participants	0 Participants	0 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Electrolytes - Potassium (low)	3 Participants	0 Participants	3 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Electrolytes - Potassium (high)	2 Participants	0 Participants	0 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Electrolytes - Magnesium (low)	0 Participants	0 Participants	1 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Enzymes - AST/GOT SGOT (high)	8 Participants	0 Participants	2 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Enzymes - ALT/GPT SGPT (high)	6 Participants	3 Participants	4 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Enzymes - Alkaline phosphatase (high)	6 Participants	1 Participants	2 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Substrates - Creatinine (high)	0 Participants	0 Participants	1 Participants
Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values Substrates - Bilirubin, total (high)	2 Participants	1 Participants	0 Participants

Adverse Events

Afatinib Monotherapy

Serious events: 18 serious events

Other events: 67 other events

Deaths: 6 deaths

Afatinib and Vinorelbine Combination Therapy

Serious events: 5 serious events

Other events: 13 other events

Deaths: 1 deaths

Afatinib and Paclitaxel Combination Therapy

Serious events: 10 serious events

Other events: 23 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Restriction type: OTHER