Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer

Summary

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Description

PRIMARY OBJECTIVE: I. To compare the progression-free survival (PFS) of bintrafusp alfa in combination with docetaxel versus (vs) docetaxel alone. SECONDARY OBJECTIVES: I. To evaluate overall survival of bintrafusp alfa in combination with docetaxel vs docetaxel alone. II. To evaluate overall respon...

PRIMARY OBJECTIVE: I. To compare the progression-free survival (PFS) of bintrafusp alfa in combination with docetaxel versus (vs) docetaxel alone. SECONDARY OBJECTIVES: I. To evaluate overall survival of bintrafusp alfa in combination with docetaxel vs docetaxel alone. II. To evaluate overall response rates of bintrafusp alfa in combination with docetaxel vs docetaxel alone. III. To evaluate duration of response of bintrafusp alfa in combination with docetaxel vs docetaxel alone. IV. To evaluate the safety of bintrafusp alfa in combination with docetaxel vs docetaxel alone. CORRELATIVE RESEARCH OBJECTIVES: I. To evaluate PD-L1, TGF-beta, and TMB as potential predictive markers of clinical response in tumor biopsies and in plasma. II. To evaluate biomarkers associated with inhibition of TGF-beta and PD-L1. III. To evaluate the changes in immune system using mass cytometry in response to TGF-beta and PD-L1 inhibition. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive docetaxel intravenously (IV) over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone. After completion of study treatment, patients are followed up at 30 days and then every 3 months for 5 years.

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