Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Evaluations (IMPACT-INSPIRE)

The patient will be observed clinically after informed consent has been obtained. Patients may require more frequent assessment or additional procedures as clinically necessary or as required by the product label.

• Each participant will have undergone comprehensive molecular profiling with results discussed at NCCS molecular tumour board. Where necessary, orthogonal studies/assays may be performed.
• The molecular profiling results will be provided by the referring physician and primary investigator/co-investigator (PI/Co-I). All cases will be presented in the NCCS Molecular Tumour Board (MTB) where there is an adequate quorum of participating members.
• The MTB will analyse the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions.
• The subsequent treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.
• Translational tissue and plasma may be additionally collected at various timepoints during the study for correlational translational research

Inclusion criteria

• Is equal to or greater than 21 years of age;
• Histologic or cytologic confirmed advanced solid tumours;
• Patients who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment;
• Ability to understand and the willingness to provide written informed consent.

Exclusion criteria

• Specific contraindications to exposure to the off-label or non-standard therapy (as defined by the product label);
• Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the protocol.