Trial Outcomes & Findings for A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients. (NCT NCT01250119)

Last Updated: 2016-03-14

Results Overview

All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

688 participants

Primary outcome timeframe

14 days

Results posted on

2016-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	Non-small-cell Lung Cancer (NSCLC) Group During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.	Erlotinib 150 Milligrams Per Day (mg/Day) During the Treatment Phase participants found to have a tumour with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until progressive disease (PD), death, unacceptable toxicity or withdrawal of consent.
Diagnostic Phase STARTED	688	0
Diagnostic Phase COMPLETED	575	0
Diagnostic Phase NOT COMPLETED	113	0
Treatment Phase STARTED	0	41
Treatment Phase COMPLETED	0	0
Treatment Phase NOT COMPLETED	0	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-small-cell Lung Cancer (NSCLC) Group During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.	Erlotinib 150 Milligrams Per Day (mg/Day) During the Treatment Phase participants found to have a tumour with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until progressive disease (PD), death, unacceptable toxicity or withdrawal of consent.
Diagnostic Phase Failed to Produce a Test Results	69	0
Diagnostic Phase Participants Not Tested	44	0
Treatment Phase Progressive Disease	0	32
Treatment Phase Death	0	2
Treatment Phase Withdrawal by Subject	0	1
Treatment Phase Adverse Event	0	2
Treatment Phase Unknown reason	0	4

Baseline Characteristics

A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NSCLC Group n=688 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
Age, Continuous	68.0 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	299 Participants n=5 Participants
Sex: Female, Male Male	389 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Diagnostic population; Only participants who were tested for EGFR mutations were included in the analysis.

All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.

Outcome measures

Outcome measures
Measure	NSCLC Group n=644 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Percentage of Participants Who Tested Positive for EGFR Mutations	8.1 percentage of participants	—

PRIMARY outcome

Timeframe: 14 Days

Population: Only participants with a valid EGFR mutations test result were included in the analysis.

Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history.

Outcome measures

Outcome measures
Measure	NSCLC Group n=52 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative n=523 Participants All participants who tested negative for EGFR mutations were included in this group.
Percentage of Participants With EGFR Mutations by Subgroup (1) Squamous cell carcinoma	0.0 percentage of participants	22.6 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (1) Adenocarcinoma	100.0 percentage of participants	67.3 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (1) Bronchoalveolar carcinoma	0 percentage of participants	1.7 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (1) Large cell carcinoma	0 percentage of participants	0.6 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (1) Other	0 percentage of participants	7.8 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (3) Greater than 70 years	26.9 percentage of participants	44.4 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (4) Male	23.1 percentage of participants	60.8 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (4) Female	76.9 percentage of participants	39.2 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (5) Asian	13.5 percentage of participants	2.9 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (5) Black	9.6 percentage of participants	3.3 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (5) Caucasian	75.0 percentage of participants	93.5 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (2) Unresectable Stage IIIB	1.9 percentage of participants	11.9 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (2) Stage IIIB with malignant effusions	1.9 percentage of participants	3.4 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (2) Stage IV	96.2 percentage of participants	84.7 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (3) Less than 70 years	73.1 percentage of participants	55.6 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (5) Other	1.9 percentage of participants	0.4 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (6) Never smoked	44.2 percentage of participants	7.8 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (6) Previous smoker	44.2 percentage of participants	60.6 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (6) Current smoker	7.7 percentage of participants	31.0 percentage of participants
Percentage of Participants With EGFR Mutations by Subgroup (6) Missing	3.8 percentage of participants	0.6 percentage of participants

SECONDARY outcome

Timeframe: Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months

Population: Intention-to-treat (ITT) population: All participants in the target population who were eligible for treatment and who actually received one dose of treatment.

Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1". Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome measures
Measure	NSCLC Group n=41 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Percentage of Participants With a Response by Best Objective Tumor Response CR	0.0 percentage of participants	—
Percentage of Participants With a Response by Best Objective Tumor Response PR	84.8 percentage of participants	—
Percentage of Participants With a Response by Best Objective Tumor Response PD	6.1 percentage of participants	—
Percentage of Participants With a Response by Best Objective Tumor Response SD	9.1 percentage of participants	—

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, 12, 15, and 18

Population: ITT population

Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	NSCLC Group n=41 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Probability of Being Alive and Free of Progression by Timepoint 12 Months	0.54 probability of being alive Interval 0.36 to 0.69	—
Probability of Being Alive and Free of Progression by Timepoint 15 Months	0.37 probability of being alive Interval 0.21 to 0.54	—
Probability of Being Alive and Free of Progression by Timepoint 18 Months	0.22 probability of being alive Interval 0.09 to 0.39	—
Probability of Being Alive and Free of Progression by Timepoint 0 Months	1.00 probability of being alive Interval 1.0 to 1.0	—
Probability of Being Alive and Free of Progression by Timepoint 3 Months	0.97 probability of being alive Interval 0.81 to 1.0	—
Probability of Being Alive and Free of Progression by Timepoint 6 Months	0.94 probability of being alive Interval 0.78 to 0.98	—
Probability of Being Alive and Free of Progression by Timepoint 9 Months	0.73 probability of being alive Interval 0.54 to 0.85	—

SECONDARY outcome

Timeframe: Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

Population: ITT population

Duration of time in months from Screening until Death due to any cause.

Outcome measures

Outcome measures
Measure	NSCLC Group n=41 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Survival Time in Months	12.57 months Interval 10.1 to 16.53	—

SECONDARY outcome

Timeframe: Screening, Baseline and Final or Withdrawal Visit up to 34 months

Population: ITT population; number (n) = number of participants analyzed for the given parameter at the specified visit.

The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement.

Outcome measures

Outcome measures
Measure	NSCLC Group n=40 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument Screening (n=40)	62.6 mm Standard Deviation 23.5	—
Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument Baseline (n=20)	65.4 mm Standard Deviation 19.9	—
Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument Final visit/Withdrawal (n=20)	63.0 mm Standard Deviation 22.4	—
Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument Change from Baseline Final visit(n=20)	-0.4 mm Standard Deviation 22.0	—

SECONDARY outcome

Timeframe: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

Population: ITT population; n = number of participants analyzed at for the given parameter at the specified visit.

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed.

Outcome measures

Outcome measures
Measure	NSCLC Group n=41 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 03 Category 2 (n=30)	43.3 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 03 Category 3 (n=30)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 04 Category 2 (n=29)	48.3 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 05 Category 1 (n=33)	54.5 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 06 Category 1 (n=31)	54.8 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 07 Category 2 (n=29)	41.4 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 07 Category 3 (n=29)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 08 Category 1 (n=27)	55.6 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 09 Category 1 (n=24)	62.5 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 09 Category 2 (n=24)	37.5 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 10 Category 2 (n=21)	57.1 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 11 Category 1 (n=13)	46.2 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 11 Category 2 (n=13)	53.8 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 11 Category 3 (n=13)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 13 Category 1 (n=9)	55.6 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 14 Category 2 (n=8)	50.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 15 Category 2 (n=5)	60.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 16 Category 1 (n=4)	25.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 16 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 17 Category 1 (n=4)	25.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 20 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 20 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 20 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 21 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 22 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 22 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 23 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 24 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 25 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Final visit/Withdraw Category 1 (n=21)	33.3 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Final visit/Withdraw Category 3 (n=21)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Screening Category 1 (n=41)	43.9 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Screening Category 2 (n=41)	56.1 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Screening Category 3 (n=41)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 01 Category 1 (n=20)	45.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 01 Category 2 (n=20)	55.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 01 Category 3 (n=20)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 02 Category 1 (n=33)	45.5 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 02 Category 2 (n=33)	54.5 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 02 Category 3 (n=33)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 03 Category 1 (n=30)	56.7 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 04 Category 1 (n=29)	51.7 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 04 Category 3 (n=29)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 05 Category 2 (n=33)	45.5 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 05 Category 3 (n=33)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 06 Category 2 (n=31)	45.2 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 06 Category 3 (n=31)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 07 Category 1 (n=29)	58.6 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 08 Category 2 (n=27)	44.4 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 08 Category 3 (n=27)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 09 Category 3 (n=24)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 10 Category 1 (n=21)	42.9 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 10 Category 3 (n=21)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 12 Category 1 (n=11)	45.5 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 12 Category 2 (n=11)	54.5 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 12 Category 3 (n=11)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 13 Category 2 (n=9)	44.4 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 13 Category 3 (n=9)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 14 Category 1 (n=8)	50.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 14 Category 3 (n=8)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 15 Category 1 (n=5)	40.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 15 Category 3 (n=5)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 16 Category 2 (n=4)	75.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 17 Category 2 (n=4)	75.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 17 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 18 Category 1 (n=3)	33.3 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 18 Category 2 (n=3)	66.7 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 18 Category 3 (n=3)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 19 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 19 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 19 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 21 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 21 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 22 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 23 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 23 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 24 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 24 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 25 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Visit 25 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D Final visit/Withdraw Category 2 (n=21)	66.7 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself.

Outcome measures

Outcome measures
Measure	NSCLC Group n=41 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Screening Category 1 (n=41)	78.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Screening Category 3 (n=41)	4.9 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 01 Category 2 (n=20)	20.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 01 Category 3 (n=20)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 03 Category 2 (n=29)	13.8 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 08 Category 2 (n=27)	14.8 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 08 - Category 3 (n=27)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 13 Category 3 (n=9)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 14 Category 1 (n=8)	62.5 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 14 Category 2 (n=8)	37.5 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 15 Category 2 (n=5)	60.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 15 Category 3 (n=5)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 16 Category 1 (n=4)	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 19 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 20 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 21 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 22 Category 1 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 22 Category 2 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 22 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 23 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 23 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Screening Category 2 (n=41)	17.1 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 01 Category 1 (n=20)	80.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 02 Category 1 (n=33)	81.8 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 02 Category 2 (n=33)	18.2 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 02 Category 3 (n=33)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 03 Category 1 (n=29)	86.2 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 03 Category 3 (n=29)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 04 Category 1 (n=28)	82.1 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 04 Category 2 (n=28)	17.9 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 04 Category 3 (n=28)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 05 Category 1 (n=33)	78.8 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 05 Category 2 (n=33)	21.2 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 05 Category 3 (n=33)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 06 Category 1 (n=31)	83.9 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 06 Category 2 (n=31)	16.1 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 06 Category 3 (n=31)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 07 Category 1 (n=29)	79.3 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 07 Category 2 (n=29)	20.7 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 07 Category 3 (n=29)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 08 Category 1 Visit 08 Category 1 (n=27)	85.2 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 09 Category 1 (n=24)	75.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 09 Category 2 (n=24)	25.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 09 Category 3 (n=24)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 10 Category 1 (n=21)	71.4 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 10 Category 2 (n=21)	28.6 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 10 Category 3 (n=21)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 11 Category 1 (n=13)	61.5 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 11 Category 2 (n=13)	38.5 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 11 Category 3 (n=13)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 12 Category 1 (n=11)	54.5 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 12 Category 2 (n=11)	45.5 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 12 Category 3 (n=11)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 13 Category 1 (n=9)	55.6 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 13 Category 2 (n=9)	44.4 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 14 Category 3 (n=8)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 15 Category 1 (n=5)	40.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 16 Category 2 ((n=4))	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 16 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 17 Category 1 (n=4)	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 17 Category 2 (n=4)	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 17 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 18 Category 1 (n=3)	33.3 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 18 Category 2 (n=3)	66.7 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 18 Category 3 (n=3)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 19 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 19 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 20 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 20 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 21 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 21 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 23 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 24 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 24 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 24 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 25 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 25 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Visit 25 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Final visit/Withdraw Category 1 (n=21)	66.7 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Final visit/Withdraw Category 2 (n=21)	33.3 percentage of participants	—
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D Final visit/Withdraw Category 3 (n=21)	0.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities.

Outcome measures

Outcome measures
Measure	NSCLC Group n=41 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 14 Category 1 (n=8)	37.5 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 14 Category 2 (n=8)	62.5 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 14 Category 3 (n=8)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 07 Category 2 (n=29)	51.7 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Screening Category 1 (n=41)	39.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Screening Category 2 (n=41)	46.3 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Screening Category 3 (n=41)	14.6 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 01 Category 1 (n=20)	40.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 01 Category 2 (n=20)	50.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 01 Category 3 (n=20)	10.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 02 Category 1 (n=33)	36.4 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 02 Category 2 (n=33)	60.6 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 02 Category 3 (n=33)	3.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 03 Category 1 (n=30)	40.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 03 Category 2 (n=30)	53.3 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 03 Category 3 (n=30)	6.7 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 04 Category 1 (n=29)	51.7 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 04 Category 2 (n=29)	44.8 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 04 Category 3 (n=29)	3.4 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 05 Category 1 (n=33)	51.5 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 05 Category 2 (n=33)	48.5 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 05 Category 3 (n=33)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 06 Category 1 (n=31)	45.2 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 06 Category 2 (n=31)	54.8 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 06 Category 3 (n=31)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 07 Category 1 (n=29)	48.3 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 07 Category 3 (n=29)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 08 Category 1 (n=27)	40.7 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 08 Category 2 (n=27)	59.3 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 08 Category 3 (n=27)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 09 Category 1 (n=24)	33.3 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 09 Category 2 (n=24)	66.7 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 09 Category 3 (n=24)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 10 Category 1 (n=21)	38.1 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 10 Category 2 (n=21)	61.9 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 10 Category 3 (n=21)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 11 Category 1 (n=13)	30.8 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 11 Category 2 (n=13)	69.2 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 11 Category 3 (n=13)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 12 Category 1 (n=11)	27.3 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 12 Category 2 (n=11)	72.7 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 12 Category 3 (n=11)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 13 Category 1 (n=9)	22.2 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 13 Category 2 (n=9)	77.8 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 13 Category 3 (n=9)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 15 Category 1 (n=5)	20.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 15 Category 2 (n=5)	80.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 15 Category 3 (n=5)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 16 Category 1 (n=4)	25.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 16 Category 2 (n=4)	75.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 16 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 17 Category 1 (n=4)	25.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 17 Category 2 (n=4)	75.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 17 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 18 Category 1 (n=3)	33.3 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 18 Category 2 (n=3)	66.7 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 18 Category 3 (n=3)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 19 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 19 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 19 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 20 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 20 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 20 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 21 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 21 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 21 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 22 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 22 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 22 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 23 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 23 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 23 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 24 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 24 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 24 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 25 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 25 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Visit 25 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Final visit/Withdrawal Category 1 (n=21)	33.3 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Final visit/Withdrawal Category 2 (n=21)	61.9 percentage of participants	—
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D Final visit/Withdrawal Category 3 (n=21)	4.8 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort.

Outcome measures

Outcome measures
Measure	NSCLC Group n=41 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 19 Category 1 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 19 Category 2 (n=2)	100.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 03 Category 3 (n=30)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 04 Category 1 (n=29)	55.2 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Screening Category 1 (n=41)	29.3 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Screening Category 2 (n=41)	63.4 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Screening Category 3 (n=41)	7.3 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 01 Category 1 (n=20)	10.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 01 Category 2 (n=20)	85.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 01 Category 3 (n=20)	5.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 02 Category 1 (n=32)	43.8 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 02 Category 2 (n=32)	56.3 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 02 Category 3 (n=32)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 03 Category 1 (n=30)	40.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 03 Category 2 (n=30)	60.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 04 Category 2 (n=29)	37.9 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 04 Category 3 (n=29)	6.9 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 05 Category 1 (n=33)	45.5 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 05 Category 2 (n=33)	51.5 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 05 Category 3 (n=33)	3.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 06 Category 1 (n=31)	48.4 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 06 Category 2 (n=31)	51.6 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 06 Category 3 (n=31)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 07 Category 1 (n=29)	48.3 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 07 Category 2 (n=29)	51.7 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 07 Category 3 (n=29)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 08 Category 1 (n=27)	37.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 08 Category 2 (n=27)	59.3 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 08 Category 3 (n=27)	3.7 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 09 Category 1 (n=24)	50.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 09 Category 2 (n=24)	37.5 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 09 Category 3 (n=24)	12.5 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 10 Category 1 (n=21)	42.9 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 10 Category 2 (n=21)	47.6 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 10 Category 3 (n=21)	9.5 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 11 Category 1 (n=13)	46.2 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 11 Category 2 (n=13)	53.8 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 11 Category 3 (n=13)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 12 Category 1 (n=11)	45.5 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 12 Category 2 (n=11)	36.4 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 12 Category 3 (n=11)	18.2 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 13 Category 1 (n=9)	44.4 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 13 Category 2 (n=9)	55.6 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 13 Category 3 (n=9)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 14 Category 1 (n=8)	62.5 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 14 Category 2 (n=8)	37.5 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 14 Category 3 (n=8)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 15 Category 1 (n=5)	60.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 15 Category 2 (n=5)	40.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 15 Category 3 (n=5)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 16 Category 1 (n=4)	25.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 16 Category 2 (n=4)	75.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 16 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 17 Category 1 (n=4)	25.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 17 Category 2 (n=4)	75.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 17 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 18 Category 1 (n=3)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 18 Category 2 (n=3)	100.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 18 Category 3 (n=3)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 19 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 20 Category 1 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 20 Category 2 (n=2)	100.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 20 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 21 Category 1 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 21 Category 2 (n=2)	100.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 21 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 22 Category 1 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 22 Category 2 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 22 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 23 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 23 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 23 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 24 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 24 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 24 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 25 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 25 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Visit 25 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Final visit/Withdrawal Category 1 (n=21)	38.1 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Final visit/Withdrawal Category 2 (n=21)	57.1 percentage of participants	—
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D Final visit/Withdrawal Category 3 (n=21)	4.8 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months

Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed.

Outcome measures

Outcome measures
Measure	NSCLC Group n=41 Participants During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.	EGFR Negative All participants who tested negative for EGFR mutations were included in this group.
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Screening Category 1 (n=40)	52.5 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Screening Category 2 (n=40)	37.5 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Screening Category 3 (n=40)	10.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 01 Category 1 (n=19)	57.9 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 01 Category 2 (n=19)	42.1 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 01 Category 3 (n=19)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 02 Category 1 (n=33)	57.6 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 02 Category 2 (n=33)	42.4 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 02 Category 3 (n=33)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 03 Category 1 (n=30)	43.3 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 03 Category 2 (n=30)	56.7 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 03 Category 3 (n=30)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 04 Category 1 (n=29)	58.6 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 04 Category 2 (n=29)	41.4 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 04 Category 3 (n=29)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 05 Category 1 (n=33)	60.6 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 05 Category 2 (n=33)	36.4 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 05 Category 3 (n=33)	3.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 06 Category 1 (n=31)	48.4 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 06 Category 2 (n=31)	51.6 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 06 Category 3 (n=31)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 07 Category 1 (n=29)	62.1 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 07 Category 2 (n=29)	37.9 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 07 Category 3 (n=29)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 08 Category 1 (n=27)	55.6 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 08 Category 2 (n=27)	44.4 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 08 Category 3 (n=27)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 09 Category 1 (n=24)	62.5 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 09 Category 2 (n=24)	25.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 09 Category 3 (n=24)	12.5 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 10 Category 1 (n=21)	61.9 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 10 Category 2 (n=21)	28.6 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 10 Category 3 (n=21)	9.5 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 11 Category 1 (n=13)	61.5 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 11 Category 2 (n=13)	30.8 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 11 Category 3 (n=13)	7.7 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 12 Category 1 (n=11)	45.5 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 12 Category 2 (n=11)	45.5 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 12 Category 3 (n=11)	9.1 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 13 Category 1 (n=9)	77.8 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 13 Category 2 (n=9)	22.2 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 13 Category 3 (n=9)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 14 Category 1 (n=8)	75.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 14 Category 2 (n=8)	25.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 14 Category 3 (n=8)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 15 Category 1 (n=5)	60.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 15 Category 2 (n=5)	40.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 15 Category 3 (n=5)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 16 Category 1 (n=4)	75.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 16 Category 2 (n=4)	25.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 16 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 17 Category 1 (n=4)	75.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 17 Category 2 (n=4)	25.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 17 Category 3 (n=4)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 18 Category 1 (n=3)	66.7 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 18 Category 2 (n=3)	33.3 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 18 Category 3 (n=3)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 19 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 19 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 19 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 20 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 20 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 20 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 21 Category 1 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 21 Category 2 (n=2)	50.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 21 Category 3 (n=2)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 22 Category 1 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 22 Category 2 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 22 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 23 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 23 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 23 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 24 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 24 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 24 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 25 Category 1 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 25 Category 2 (n=1)	100.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Visit 25 Category 3 (n=1)	0.0 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Final visit/Withdrawal Category 1 (n=21)	57.1 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Final visit/Withdrawal Category 2 (n=21)	38.1 percentage of participants	—
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D Final visit/Withdrawal Category 3 (n=21)	4.8 percentage of participants	—

Adverse Events

Erlotinib 150 mg/Day

Serious events: 16 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib 150 mg/Day n=41 participants at risk During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
Blood and lymphatic system disorders Thrombocytopenia	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Cardiac disorders Angina pectoris	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Ear and labyrinth disorders Vertigo	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Abdominal pain	4.9% 2/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Constipation	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Diarrhoea	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
General disorders Pyrexia	4.9% 2/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Infections and infestations Urinary tract infection	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Injury, poisoning and procedural complications Femur fracture	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Nervous system disorders Cerebral infarction	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Nervous system disorders Presyncope	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Nervous system disorders Spinal cord compression	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Vascular disorders Deep vein thrombosis	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Gastrointestinal Hemorrhage	2.4% 1/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.

Other adverse events

Other adverse events
Measure	Erlotinib 150 mg/Day n=41 participants at risk During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
Blood and lymphatic system disorders Anaemia	17.1% 7/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Eye disorders Conjunctivitis	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Eye disorders Dry eye	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Eye disorders Vision blurred	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Abdominal pain	12.2% 5/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Abdominal pain upper	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Constipation	22.0% 9/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Diarrhoea	63.4% 26/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Dyspepsia	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Nausea	26.8% 11/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Gastrointestinal disorders Oral pain	12.2% 5/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
General disorders Asthenia	9.8% 4/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
General disorders Chest pain	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
General disorders Fatigue	34.1% 14/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
General disorders Mucosal inflammation	14.6% 6/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
General disorders Oedema peripheral	17.1% 7/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
General disorders Pain	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Infections and infestations Cellulitis	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Infections and infestations Lower respiratory tract infection	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Infections and infestations Nasopharyngitis	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Infections and infestations Oral candidiasis	9.8% 4/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Infections and infestations Paronychia	19.5% 8/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Infections and infestations Urinary tract infection	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Investigations Pulmonary function test decreased	14.6% 6/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Metabolism and nutrition disorders Decreased appetite	24.4% 10/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Musculoskeletal and connective tissue disorders Arthralgia	17.1% 7/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Musculoskeletal and connective tissue disorders Back pain	14.6% 6/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Musculoskeletal and connective tissue disorders Muscle spasms	9.8% 4/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.8% 4/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Musculoskeletal and connective tissue disorders Pain in extremity	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Nervous system disorders Dysgeusia	9.8% 4/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Respiratory, thoracic and mediastinal disorders Cough	24.4% 10/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.2% 5/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.2% 5/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Skin and subcutaneous tissue disorders Alopecia	22.0% 9/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Skin and subcutaneous tissue disorders Dermatitis acneiform	12.2% 5/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Skin and subcutaneous tissue disorders Dry skin	31.7% 13/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Skin and subcutaneous tissue disorders Pruritus	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Skin and subcutaneous tissue disorders Rash	63.4% 26/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.
Skin and subcutaneous tissue disorders Skin ulcer	7.3% 3/41 • Adverse events were recorded from Visit 1 (Baseline) until 30 days after the Final/Withdrawal Visit.

Additional Information

Medical Communications

Hoffmann- LaRoche

Phone: 1-800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER