Clinical trial NCT01998919: A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
Official title: A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-02
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
* measurable disease;
* no previous chemotherapy for non-small cell lung cancer.

Exclusion Criteria:

* unstable systemic disease;
* any other malignancies in the last 5 years.

Primary outcomes:
measure: Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
timeFrame: Week 16
measure: Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
timeFrame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
measure: Duration of Response
timeFrame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
measure: Time to Progression
timeFrame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
measure: Progression-Free Survival (PFS)
timeFrame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
measure: Overall Survival
timeFrame: Date of randomization until date of death or date of last follow-up assessment
Other outcomes:
Locations:
city: Campbelltown
country: Australia
city: Camperdown
country: Australia
city: Liverpool
country: Australia
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Hong Kong
country: Hong Kong
city: Jakarta
country: Indonesia
city: Jakarta
country: Indonesia
city: Jogjakarta
country: Indonesia
city: Semarang
country: Indonesia
city: Kyunggi-do
country: Korea, Republic of
city: Manila
country: Philippines
city: Metro Manila
country: Philippines
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: