A Study of First-line Maintenance Erlotinib Versus Erlotinib at Disease Progression in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Platinum-Based Chemotherapy
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Disease Progression
Intervention: Placebo; Erlotinib; Second-Line Chemotherapy
Intervention description: Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity.; Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.; Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 643.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This double-blind, placebo-controlled study will evaluate the benefit of first-line
      maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in
      participants with advanced NSCLC who have not progressed following 4 cycles of platinum
      based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor
      (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150
      milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will
      receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on
      erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will
      continue until disease progression, death, or unacceptable toxicity. Participants may also be
      entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than or equal to (≥) 18 years of age, or legal age of consent if
             greater than 18

          -  Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC

          -  Completion of 4 cycles of platinum-based chemotherapy without progression (end of last
             chemotherapy cycle less than or equal to [≤] 28 days prior to randomization)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion Criteria:

          -  Prior exposure to agents directed at human epidermal growth factor receptor (HER) axis
             (e.g. erlotinib, gefitinib, cetuximab)

          -  Participants whose tumors harbor an EGFR-activating mutation

          -  Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced
             disease before Screening

          -  Use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy
             run-in)

          -  Participants who have undergone complete tumor 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

          -  Central nervous system (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

          -  Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection

          -  Any inflammatory changes of the surface of the eye