A Study Evaluating Dalotuzumab (MK-0646) in Combination With Erlotinib for Participants With Non-Small Cell Lung Cancer (MK-0646-007)
Condition: Carcinoma, Non-small-cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Dalotuzumab; Erlotinib
Intervention description: Dalotuzumab 20 mg/mL in sterile solution. Intravenous (IV) infusion over 60 minutes at 5 mg/kg, administered weekly at dosage according to treatment group.; Open-label erlotinib administrated orally (tablets) by mouth (PO) at 150 mg daily.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase I/IIa study to evaluate safety and efficacy of dalotuzumab (MK-0646) in
      combination with erlotinib in participants with recurrent Non-Small Cell Lung Cancer (NSCLC).
      The Phase I part of this study will determine the highest tolerated dose of dalotuzumab to be
      given in combination with erlotinib. The primary hypothesis for the Phase I part of the study
      is that administration of erlotinib in combination with dalotuzumab in participants with
      recurrent NSCLC is generally well-tolerated as evidenced by accumulated safety data from this
      trial. The Phase II part of this study will investigate how well dalotuzumab works in
      conjunction with erlotinib at treating recurrent NSCLC. The primary hypothesis for the Phase
      II part of this study is that administration of erlotinib in combination with dalotuzumab in
      participants with recurrent NSCLC results in improvement in Progression Free Survival (PFS)
      compared to participants treated with erlotinib alone. PFS is defined as the time from
      randomization until either the emergence of radiographic evidence of disease progression (as
      documented by an independent core laboratory) or death due to any cause, whichever occurs
      first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has locally advanced or metastatic stage IIIB/IV NSCLC that has relapsed
             after hemotherapy/chemoratiotherapy

          -  Participant has had at least one chemotherapy regimen for recurrent or metastatic
             disease

          -  Participant is 18 years of age or older

          -  Participant has a performance status of 0-2 on Eastern Cooperative Group (ECOG) scale

          -  Women of childbearing potential have a negative pregnancy test

        Exclusion Criteria:

          -  Participant has had chemotherapy within 2 weeks or biological therapy (e.g.
             bevacizumab) within 4 weeks

          -  Participant has not recovered from adverse events from previous therapy within 4 weeks

          -  Participant has received EGFR-Tyrosine Kinase Inhibitor (TKI) inhibitor/anti-EGFR mAb
             therapy

          -  Participant has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy

          -  Participant has had more than 2 systemic chemotherapies for metastatic disease

          -  Participant has not completed radiotherapy with complete resolution of toxicities at
             least 2 weeks before starting in the study

          -  Participant is taking part in another clinical study

          -  Participant has a primary central nervous system tumor

          -  Participant abuses drugs or alcohol

          -  Participant is pregnant or breastfeeding

          -  Participant is Human Immunodeficiency Virus (HIV) positive

          -  Participant has a history of hepatitis B or C

          -  Participant is using growth hormone or growth hormone inhibitors