1. Objectives | |
1.1 Primary Objective | |
■ To compare the efficacy of treatment with trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab | |
1.2 Secondary Objectives | |
■ To compare efficacy, safety and patient reported quality of life (QoL) of treatment with trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab | |
1.3 Other Exploratory Objectives | |
■ Further anti-tumor treatment after discontinuation of study treatment | |
1.4 Translational Research Objectives | |
■ Identification and characterization of patient subgroups with greatest or lowest benefit from respective treatment including efficacy and toxicity | |
2. Endpoints | |
2.1 Primary Endpoints | |
■ Objective response rate (ORR) according to RECIST 1.1 (assessment at the local trial center) | |
2.2 Secondary Endpoints | |
Efficacy | |
■ Overall survival (OS) | |
■ Progression-free survival (PFS) | |
■ Objective response rate (ORR) according to RECIST 1.1 (assessment by central review) | |
■ Depth of response (DoR) (assessment by central review) | |
■ Early tumor shrinkage ([ETS]; assessment by central review) | |
Quality of Life | |
■ QoL as assessed with the QoL questionnaire EQ-5D-5L | |
Safety | |
■ Type, incidence, severity, and causal relationship to investigational medicinal products (IMPs) of non-serious adverse events (AE) and serious adverse events (SAE; severity evaluated according to CTCAE version 5.0) | |
2.3 Other Exploratory Endpoints | |
■ Subsequent anti-tumor treatment lines (monotherapy and combination therapy treatment lines including medicinal products [chemotherapeutics, antibodies and targeted therapy] and investigator reported efficacy of subsequent treatment lines |