Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Recurrence

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Endothelial Growth Factors

Mitogens

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

erlotinib [Tarceva]

Clinical Trials

This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.

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.

Assess the Incidence of Mutations in the Tyrosine Kinase Domain of the Endothelial Growth Factor Receptor in UK Patients With Newly Diagnosed Metastatic or Recurrent Non-small Cell Lung Cancer and to Investigate the Quality of Life of These Patients Undergoing First-line Therapy With Erlotinib.

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

Hoffmann-La Roche

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.

Erlotinib 150 mg/Day

During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.

NSCLC Group

Age, Continuous

Sex: Female, Male

Diagnostic population: All participants newly diagnosed with recurrent or metastatic NSCLC who entered the study and signed the consent form were included in this population.

Medical Communications

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

Percentage of Participants Who Tested Positive for EGFR Mutations

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

Percentage of Participants With a Response by Best Objective Tumor Response

(1) Squamous cell carcinoma

(1) Adenocarcinoma

(1) Bronchoalveolar carcinoma

(1) Large cell carcinoma

(1) Other

(2) Unresectable Stage IIIB

(2) Stage IIIB with malignant effusions

(2) Stage IV

(3) Less than 70 years

(3) Greater than 70 years

(4) Male

(4) Female

(5) Asian

(5) Black

(5) Caucasian

(5) Other

(6) Never smoked

(6) Previous smoker

(6) Current smoker

(6) Missing

All participants who tested positive for EGFR mutations were included in this group.

EGFR Positive

All participants who tested negative for EGFR mutations were included in this group.

EGFR Negative

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

Percentage of Participants With EGFR Mutations by Subgroup

0 Months

3 Months

6 Months

9 Months

12 Months

15 Months

18 Months

Probability of Being Alive and Free of Progression by Timepoint

Survival Time in Months

Screening (n=40)

Baseline (n=20)

Final visit/Withdrawal (n=20)

Change from Baseline Final visit(n=20)

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

Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument

Screening Category 1 (n=41)

Screening Category 2 (n=41)

Screening Category 3 (n=41)

Visit 01 Category 1 (n=20)

Visit 01 Category 2 (n=20)

Visit 01 Category 3 (n=20)

Visit 02 Category 1 (n=33)

Visit 02 Category 2 (n=33)

Visit 02 Category 3 (n=33)

Visit 03 Category 1 (n=30)

Visit 03 Category 2 (n=30)

Visit 03 Category 3 (n=30)

Visit 04 Category 1 (n=29)

Visit 04 Category 2 (n=29)

Visit 04 Category 3 (n=29)

Visit 05 Category 1 (n=33)

Visit 05 Category 2 (n=33)

Visit 05 Category 3 (n=33)

Visit 06 Category 1 (n=31)

Visit 06 Category 2 (n=31)

Visit 06 Category 3 (n=31)

Visit 07 Category 1 (n=29)

Visit 07 Category 2 (n=29)

Visit 07 Category 3 (n=29)

Visit 08 Category 1 (n=27)

Visit 08 Category 2 (n=27)

Visit 08 Category 3 (n=27)

Visit 09 Category 1 (n=24)

Visit 09 Category 2 (n=24)

Visit 09 Category 3 (n=24)

Visit 10 Category 1 (n=21)

Visit 10 Category 2 (n=21)

Visit 10 Category 3 (n=21)

Visit 11 Category 1 (n=13)

Visit 11 Category 2 (n=13)

Visit 11 Category 3 (n=13)

Visit 12 Category 1 (n=11)

Visit 12 Category 2 (n=11)

Visit 12 Category 3 (n=11)

Visit 13 Category 1 (n=9)

Visit 13 Category 2 (n=9)

Visit 13 Category 3 (n=9)

Visit 14 Category 1 (n=8)

Visit 14 Category 2 (n=8)

Visit 14 Category 3 (n=8)

Visit 15 Category 1 (n=5)

Visit 15 Category 2 (n=5)

Visit 15 Category 3 (n=5)

Visit 16 Category 1 (n=4)

Visit 16 Category 2 (n=4)

Visit 16 Category 3 (n=4)

Visit 17 Category 1 (n=4)

Visit 17 Category 2 (n=4)

Visit 17 Category 3 (n=4)

Visit 18 Category 1 (n=3)

Visit 18 Category 2 (n=3)

Visit 18 Category 3 (n=3)

Visit 19 Category 1 (n=2)

Visit 19 Category 2 (n=2)

Visit 19 Category 3 (n=2)

Visit 20 Category 1 (n=2)

Visit 20 Category 2 (n=2)

Visit 20 Category 3 (n=2)

Visit 21 Category 1 (n=2)

Visit 21 Category 2 (n=2)

Visit 21 Category 3 (n=2)

Visit 22 Category 1 (n=1)

Visit 22 Category 2 (n=1)

Visit 22 Category 3 (n=1)

Visit 23 Category 1 (n=1)

Visit 23 Category 2 (n=1)

Visit 23 Category 3 (n=1)

Visit 24 Category 1 (n=1)

Visit 24 Category 2 (n=1)

Visit 24 Category 3 (n=1)

Visit 25 Category 1 (n=1)

Visit 25 Category 2 (n=1)

Visit 25 Category 3 (n=1)

Final visit/Withdraw Category 1 (n=21)

Final visit/Withdraw Category 2 (n=21)

Final visit/Withdraw Category 3 (n=21)

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

Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D

Visit 03 Category 1 (n=29)

Visit 03 Category 2 (n=29)

Visit 03 Category 3 (n=29)

Visit 04 Category 1 (n=28)

Visit 04 Category 2 (n=28)

Visit 04 Category 3 (n=28)

Visit 08 Category 1 Visit 08 Category 1 (n=27)

Visit 08 - Category 3 (n=27)

Visit 16 Category 2 ((n=4))

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

Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D

Final visit/Withdrawal Category 1 (n=21)

Final visit/Withdrawal Category 2 (n=21)

Final visit/Withdrawal Category 3 (n=21)

Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D

Spots Global Cancer Trial Database 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.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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