NCT01609543

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2012

Typical duration for phase_4

Geographic Reach
3 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 1, 2016

Completed
Last Updated

February 1, 2016

Status Verified

December 1, 2015

Enrollment Period

2.7 years

First QC Date

May 30, 2012

Results QC Date

December 29, 2015

Last Update Submit

December 29, 2015

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to progressive disease or death (up to 34 months)

Secondary Outcomes (2)

  • Percentage of Participants With Best Overall Response (BOR)

    Baseline to progressive disease or death (up to 34 months)

  • Percentage of Participants Who Were Alive at 1 Year

    1 Year (12 months)

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: erlotinib [Tarceva]

Interventions

erlotinib [Tarceva]DRUG

150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Unknown Facility

Budapest, 1125, Hungary

Location

Unknown Facility

Budapest, 1529, Hungary

Location

Unknown Facility

Debrecen, 4032, Hungary

Location

Unknown Facility

Deszk, 6772, Hungary

Location

Unknown Facility

Farkasgyepű, 8582, Hungary

Location

Unknown Facility

Gyula, 5703, Hungary

Location

Unknown Facility

Mátraháza, 3233, Hungary

Location

Unknown Facility

Mosonmagyaróvar, 9200, Hungary

Location

Unknown Facility

Nyíregyháza, 4400, Hungary

Location

Unknown Facility

Pécs, 7623, Hungary

Location

Unknown Facility

Szekszárd, 7100, Hungary

Location

Unknown Facility

Székesfehérvár, 8001, Hungary

Location

Unknown Facility

Szolnok, 5004, Hungary

Location

Unknown Facility

Szombathely, 9700, Hungary

Location

Unknown Facility

Törökbálint, 2045, Hungary

Location

Unknown Facility

Törökbálint, H-2045, Hungary

Location

Unknown Facility

Riga, LV 1079, Latvia

Location

Unknown Facility

Riga, LV-1002, Latvia

Location

Unknown Facility

Ankara, 06230, Turkey (Türkiye)

Location

Unknown Facility

Ankara, 06280, Turkey (Türkiye)

Location

Unknown Facility

Antalya, 07070, Turkey (Türkiye)

Location

Unknown Facility

Edirne, 22030, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 29801465DERIVED

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 1, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 1, 2016

Results First Posted

February 1, 2016

Record last verified: 2015-12

Locations

LA(2)HU(16)TU(5)