Author of

• 20168

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  P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Clinical Design, Statistics and Clinical Trials
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 23339

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    P2.04-010 - Afatinib in Combination with Pembrolizumab in Patients with Stage IIIB/IV Squamous Cell Carcinoma (SCC) of the Lung (ID 9425)

    09:30 - 09:30  |  Author(s): M.J. Chisamore
    • Abstract
    • Slides

    Background:
    Afatinib has demonstrated progression-free survival (PFS) and overall survival (OS) improvements in patients with squamous cell carcinoma (SCC) of the lung; pembrolizumab also showed encouraging PFS/OS in lung SCC. Afatinib is a selective and irreversible ErbB family blocker that effectively inhibits signaling from all homo- and heterodimers formed by ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3, and ErbB4. Pembrolizumab is a humanized immunoglobulin G4 (IgG4) monoclonal antibody with high affinity and potent receptor-blocking activity for the programmed cell death 1 (PD-1) receptor. Concurrent inhibition of PD-1 and EGFR pathways represents a rational and promising approach for EGFR-driven tumors such as SCC of the lung, to increase the rate and duration of response, and delay the development of resistance, as single-agent efficacy can be moderate and more treatment options are needed. This trial assesses the efficacy and safety of afatinib in combination with pembrolizumab in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who progressed during or after first-line platinum-based treatment.
    
    Method:
    Trial design: Study 1200.283 (NCT03157089. LUX-Lung IO / Keynote 497) is a phase II, open-label, non-randomized single-arm study. Eligible patients have locally advanced or metastatic squamous NSCLC and have progressed during/after first-line platinum-based chemotherapy. Patients must have adequate organ function and ECOG PS 0/1. Prior treatment with immune checkpoint inhibitors or EGFR targeted therapy is prohibited. A safety run-in will be performed using afatinib once daily (starting dose 40 mg) in combination with pembrolizumab, (200 mg fixed dose once every 3 weeks, administered intravenously) to assess the safety profile and confirm the recommended Phase II dose (RP2D). In the main part of the trial, afatinib at the RP2D, in combination with pembrolizumab, may be continued for a maximum of 35 cycles (~2 years). After study completion, further therapy will be decided by the investigator and may include afatinib. Dose reduction of afatinib to 30 mg or 20 mg will be permitted in the case of adverse events. The primary endpoint is investigator assessed objective response (complete response [CR] or partial response [PR] according to RECIST v1.1). Secondary/further endpoints are disease control (CR, PR, or stable disease), duration of objective response, PFS, OS, tumor shrinkage, RP2D, and pharmacokinetics. Exploratory biomarker analysis will also be performed. This study will be conducted in the US, Spain, France, Korea, and Turkey, and will open for enrollment in September 2017; target enrollment is 50-60 patients.
    
    Result:
    Not applicable
    
    Conclusion:
    Not applicable
    
    

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