Back to resultsA Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Erlotinib
Second-Line Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18
- Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC
- Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less than or equal to [≤] 28 days prior to randomization)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
- Prior exposure to agents directed at human epidermal growth factor receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab)
- Participants whose tumors harbor an EGFR-activating mutation
- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before Screening
- Use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy run-in)
- Participants who have undergone complete tumor resection after responding to the platinum-based chemotherapy during the Screening phase
- Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ, or organ-confined prostate cancer
- Central nervous system (CNS) metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for ≥2 months
- Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
- Any inflammatory changes of the surface of the eye
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Early Erlotinib
Late Erlotinib
Arm Description
Participants will receive blinded erlotinib as 150 mg PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Participants will receive blinded placebo tablets PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive second-line erlotinib as 150 mg PO once daily until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Died During the Overall Study
Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.
Overall Survival (OS) as Median Time to Event During the Overall Study
Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months.
Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study
Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated.
Secondary Outcome Measures
Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment
Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated.
Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment
Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks.
Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment
Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated.
Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment
Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.
Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment
Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.
Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment
Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01328951
Brief Title
A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase III Study of First-Line Maintenance Tarceva Versus Tarceva at the Time of Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-Based Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
643 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Erlotinib
Arm Type
Experimental
Arm Description
Participants will receive blinded erlotinib as 150 mg PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Arm Title
Late Erlotinib
Arm Type
Placebo Comparator
Arm Description
Participants will receive blinded placebo tablets PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive second-line erlotinib as 150 mg PO once daily until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.
Intervention Type
Drug
Intervention Name(s)
Second-Line Chemotherapy
Intervention Description
Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Died During the Overall Study
Description
Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.
Time Frame
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)
Title
Overall Survival (OS) as Median Time to Event During the Overall Study
Description
Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months.
Time Frame
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)
Title
Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study
Description
Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated.
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment
Description
Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated.
Time Frame
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Title
Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment
Description
Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks.
Time Frame
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Title
Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment
Description
Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated.
Time Frame
At 6 months
Title
Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment
Description
Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.
Time Frame
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Title
Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment
Description
Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.
Time Frame
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
Title
Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment
Description
Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.
Time Frame
Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18
Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC
Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less than or equal to [≤] 28 days prior to randomization)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
Prior exposure to agents directed at human epidermal growth factor receptor (HER) axis (e.g. erlotinib, gefitinib, cetuximab)
Participants whose tumors harbor an EGFR-activating mutation
Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before Screening
Use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy run-in)
Participants who have undergone complete tumor resection after responding to the platinum-based chemotherapy during the Screening phase
Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ, or organ-confined prostate cancer
Central nervous system (CNS) metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for ≥2 months
Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
Any inflammatory changes of the surface of the eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-281
Country
Brazil
City
Ijuí
State/Province
RO
ZIP/Postal Code
98700-000
Country
Brazil
City
Lajeado
State/Province
RS
ZIP/Postal Code
95900-000
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-090
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90470340
Country
Brazil
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88034-000
Country
Brazil
City
Santo André
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Beijing
ZIP/Postal Code
100142
Country
China
City
Beijing
ZIP/Postal Code
100730
Country
China
City
Changchun
ZIP/Postal Code
130012
Country
China
City
Fuzhou
ZIP/Postal Code
350014
Country
China
City
Guangzhou
ZIP/Postal Code
510515
Country
China
City
Guangzhou
Country
China
City
Harbin
ZIP/Postal Code
150081
Country
China
City
Shanghai
ZIP/Postal Code
200030
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
City
Shantou
ZIP/Postal Code
515041
Country
China
City
Shenyang
ZIP/Postal Code
110001
Country
China
City
Suzhou
ZIP/Postal Code
215004
Country
China
City
Tianjin
ZIP/Postal Code
300060
Country
China
City
Wuhan
ZIP/Postal Code
430071
Country
China
City
Xi'an
ZIP/Postal Code
710061
Country
China
City
Ceske Budejovice
ZIP/Postal Code
370 87
Country
Czech Republic
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czech Republic
City
Nymburk
ZIP/Postal Code
288 01
Country
Czech Republic
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czech Republic
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
City
Praha
ZIP/Postal Code
150 06
Country
Czech Republic
City
Tabor
ZIP/Postal Code
390 03
Country
Czech Republic
City
Bayonne
ZIP/Postal Code
64109
Country
France
City
Compiegne
ZIP/Postal Code
60321
Country
France
City
Gap
ZIP/Postal Code
05007
Country
France
City
Libourne
ZIP/Postal Code
33505
Country
France
City
Lille
ZIP/Postal Code
59020
Country
France
City
Nantes
ZIP/Postal Code
44202
Country
France
City
St Brieuc
ZIP/Postal Code
22027
Country
France
City
Villefranche-sur-Saone
ZIP/Postal Code
69655
Country
France
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
City
Avellino
State/Province
Campania
ZIP/Postal Code
83100
Country
Italy
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00151
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
City
Legnago
State/Province
Lombardia
ZIP/Postal Code
37045
Country
Italy
City
Treviglio
State/Province
Lombardia
ZIP/Postal Code
24047
Country
Italy
City
S. Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
City
Livorno
State/Province
Toscana
ZIP/Postal Code
57124
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
City
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
City
Suwon
ZIP/Postal Code
442-723
Country
Korea, Republic of
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1079
Country
Latvia
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
City
Arnhem
ZIP/Postal Code
6800 TA
Country
Netherlands
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
City
Hoorn
ZIP/Postal Code
1625 HV
Country
Netherlands
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
City
Wodzislaw Slaski
ZIP/Postal Code
44-300
Country
Poland
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
City
Braila
ZIP/Postal Code
810325
Country
Romania
City
Brasov
ZIP/Postal Code
500091
Country
Romania
City
Brasov
ZIP/Postal Code
500152
Country
Romania
City
Bucuresti
ZIP/Postal Code
010976
Country
Romania
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400058
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400132
Country
Romania
City
Oradea
ZIP/Postal Code
410167
Country
Romania
City
Ploiesti
ZIP/Postal Code
100337
Country
Romania
City
Targu-Mures
ZIP/Postal Code
540136
Country
Romania
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
City
Kosice
ZIP/Postal Code
04001
Country
Slovakia
City
Nove Zamky
ZIP/Postal Code
940 02
Country
Slovakia
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
City
George
ZIP/Postal Code
6530
Country
South Africa
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
City
Kaohsiung
ZIP/Postal Code
00833
Country
Taiwan
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
City
Muang
ZIP/Postal Code
50200
Country
Thailand
City
Muang
ZIP/Postal Code
57000
Country
Thailand
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
City
Kirovograd
ZIP/Postal Code
25011
Country
Ukraine
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
City
Lutsk
ZIP/Postal Code
63000
Country
Ukraine
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
City
Vinnytsya
ZIP/Postal Code
21029
Country
Ukraine
City
Zaporizhzhya
ZIP/Postal Code
69040
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
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