Activity of dalotuzumab, a selective anti-IGF1R antibody, in combination with erlotinib in unselected patients with Non-small-cell lung cancer: A phase I/II randomized trial

Teresa Moran, Enriqueta Felip, Vicki Keedy, Hossein Borghaei, Frances A. Shepherd, Amelia Insa, Holly Brown, Timothy Fitzgerald, Sriram Sathyanarayanan, John F. Reilly, David Mauro, Karl Hsu, Li Yan, David H. Johnson

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Background: We investigated the safety and antitumor activity of dalotuzumab, a selective anti-insulin growth factor 1 receptor monoclonal antibody (IGF1R MoAb), plus erlotinib in a sequential phase I/II trial in unselected patients with refractory advanced non-small-cell lung cancer (NSCLC).The phase I trial determined the recommended dose and safety of erlotinib plus dalotuzumab at 5 mg/kg or 10 mg/kg weekly in 20 patients. The phase II trial compared outcomes to erlotinib alone and erlotinib plus dalotuzumab at the mg/kg established in the phase I trial. Results: Erlotinib at 150 mg plus dalotuzumab at 10 mg/kg was safe. The phase II trial included 37 patients in the erlotinib arm and 38 patients in the erlotinib plus dalotuzumab arm. Progression-free survival was 1.6 versus 2.5 months, overall survival was 10.2 and 6.6 months, and the objective response rate was 7.9% and 2.7%, respectively, with no significant differences between the two arms. Grade 3-5 adverse events occurred in 11 (28.9%) versus 13 (35.1%) patients, respectively. The most frequent adverse events were asthenia (36.8% vs. 37.8%), dehydration (5.3% vs. 2.7%), diarrhea (71% vs. 81.1%), hyperglycemia (13.1% vs.18.9%), and skin-related toxicities (92.1% vs. 86.4%). Conclusion: The addition of dalotuzumab to erlotinib did not improve efficacy outcome in patients with refractory advanced NSCLC.

Original languageEnglish (US)
Article number26
JournalExperimental Hematology and Oncology
Issue number1
Publication statusPublished - Nov 7 2014



  • Dalotuzumab
  • Epidermal growth factor receptor
  • Insulin growth factor receptor
  • Non-small-cell lung cancer
  • Phase I/II trial

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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