Clinical trial NCT01230710: A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
Official title: A Multi-centre, Open-label, Phase IV, Interventional Study to Evaluate the Efficacy of Erlotinib (Tarceva®) Following 4 Cycles of Platinum-based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years of age.
* Histologically documented non-small cell lung cancer (NSCLC).
* Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
* Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Patients of reproductive potential must agree to use effective contraception.

Exclusion Criteria:

* Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
* Prior treatment with any monoclonal antibody therapy.
* Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
* Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
* Pre-existing interstitial lung disease.
* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
* Pregnant or lactating women.

Primary outcomes:
measure: Percentage of Participants With Progression-free Survival at Week 52
timeFrame: From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From the date of enrolment until the end of the study (up to 2 years, 6 months).
measure: Overall Survival
timeFrame: From the date of enrolment until the end of the study (up to 2 years, 6 months).
measure: Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)
timeFrame: From the date of enrolment until the end of the study (up to 2 years, 6 months).
measure: Percentage of Participants With Disease Control
timeFrame: From the date of enrolment until the end of the study (up to 2 years, 6 months).
Other outcomes:
Locations:
city: Bangalore
country: India
city: Chennai
country: India
city: Delhi
country: India
city: Hyderabad
country: India
city: Jaipur
country: India
city: Kolkata
country: India
city: Nasik
country: India
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: