Clinical trial NCT02774278: A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)
Official title: MERIT - A Phase II Marker Identification Trial for Tarceva in Second Line NSCLC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-05-17
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.


Eligibility criteria: Inclusion Criteria:

* Advanced NSCLC
* Tumor accessible for biopsy by bronchoscopy
* Disease progression following course of standard chemotherapy, or participants unwilling/unable to undergo chemotherapy

Exclusion Criteria:

* Unstable systemic disease
* Any other malignancies in the last 5 years
* Brain metastases
* Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR) axis

Primary outcomes:
measure: Number of Differentially Expressed Genes Associated With Clinical Benefit
timeFrame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
measure: Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit
timeFrame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
measure: Number of KRAS Mutation Participants Who Achieved Clinical Benefit
timeFrame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Secondary outcomes:
measure: Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
measure: Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST
timeFrame: Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
city: Sofia
country: Bulgaria
city: Tallin
country: Estonia
city: Tartu
country: Estonia
city: Montpellier
country: France
city: Paris
country: France
city: Grosshansdorf
country: Germany
city: Köln
country: Germany
city: Hong Kong
country: Hong Kong
city: Dublin
country: Ireland
city: Perugia
country: Italy
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Singapore
country: Singapore
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Weston Super Mare
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: