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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of First-line Maintenance Tarceva vs Tarceva at the Time of Disease Progression in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-based Chemotherapy


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of First-line Maintenance Tarceva vs Tarceva at the Time of Disease Progression in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-based Chemotherapy


Inclusion Criteria:



- Adult patients, >/= 18 years of age (or >/= legal age of consent if greater than 18)

- Advanced or recurrent (Stage IIIb) or metastatic (Stage IV) non-small cell lung
cancer (NSCLC)

- Completion of 4 cycles of platinum-based chemotherapy without progression (end of
last chemotherapy cycle
- ECOG performance status 0-1

Exclusion Criteria:

- Prior exposure to agents directed at HER axis (e.g. erlotinib, gafitinib, cetuximab)

- Patients whose tumours harbour an EGFR activating mutation

- Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced
disease before screening (platinum-based chemotherapy)

- Use of pemetrexed in maintenance setting (pemetrexed is allowed during the
chemotherapy run-in)

- Patients who have undergone complete tumour resection after responding to the
platinum-based chemotherapy during the screening phase

- Any other malignancies within 5 years, except for curatively resected carcinoma in
situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ or
organ confined prostate cancer

- CNS metastases or spinal cord compression that has not been definitely treated with
surgery and/or radiation, or treated CNS metastases or spinal cord compression
without stable disease for >/= 2 months

- HIV, hepatitis B or hepatitis C infection

- Any inflammatory changes of the surface of the eye

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS): First-line maintenance Tarceva versus Tarceva at time of disease progression

Outcome Time Frame:

42 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BO25460

NCT ID:

NCT01328951

Start Date:

September 2011

Completion Date:

December 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Disease Progression

Name

Location

Great Falls, Montana  59405
Fountain Valley, California  92708
Columbia, Missouri  65203
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Seattle, Washington  98195
Lebanon, New Hampshire  
Washington, District of Columbia