Back to resultsA Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
erlotinib [Tarceva]
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
- Non-small cell lung cancer with an EGFR activating mutation
- Patients must have evidence of disease, but measurable disease is not mandatory
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate renal and liver function
Exclusion Criteria:
- Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
- Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
- Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
- Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
- Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
- Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
- Pregnant or breast-feeding women
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS)
PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.
Secondary Outcome Measures
Percentage of Participants With Best Overall Response (BOR)
BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeters [mm] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Percentage of Participants Who Were Alive at 1 Year
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01609543
Brief Title
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
Official Title
Open Label Study of Erlotinib (Tarceva®) as Single Agent First Line Treatment of Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With Activating Epidermal Growth Factor Receptor (EGFR) Mutations
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (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 open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
erlotinib [Tarceva]
Intervention Description
150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.
Time Frame
Baseline to progressive disease or death (up to 34 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Best Overall Response (BOR)
Description
BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeters [mm] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame
Baseline to progressive disease or death (up to 34 months)
Title
Percentage of Participants Who Were Alive at 1 Year
Time Frame
1 Year (12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >/= 18 years of age
Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
Non-small cell lung cancer with an EGFR activating mutation
Patients must have evidence of disease, but measurable disease is not mandatory
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate renal and liver function
Exclusion Criteria:
Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
Pregnant or breast-feeding women
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
Budapest
ZIP/Postal Code
1125
Country
Hungary
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
City
Mosonmagyaróvar
ZIP/Postal Code
9200
Country
Hungary
City
Mátraháza
ZIP/Postal Code
3233
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8001
Country
Hungary
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
City
Törökbálint
ZIP/Postal Code
H-2045
Country
Hungary
City
Riga
ZIP/Postal Code
LV 1079
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
City
Ankara
ZIP/Postal Code
06280
Country
Turkey
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
29801465
Citation
Markoczy Z, Sarosi V, Kudaba I, Galffy G, Turay UY, Demirkazik A, Purkalne G, Somfay A, Papai-Szekely Z, Raso E, Ostoros G. Erlotinib as single agent first line treatment in locally advanced or metastatic activating EGFR mutation-positive lung adenocarcinoma (CEETAC): an open-label, non-randomized, multicenter, phase IV clinical trial. BMC Cancer. 2018 May 25;18(1):598. doi: 10.1186/s12885-018-4283-z.
Results Reference
derived
Learn more about this trial
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
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