Sotorasib in advanced KRAS G12C-mutated non-small cell lung cancer patients with comorbidities (SOLUCOM)

Conditions

KRAS G12C-mutated non-small cell lung cancer

Brief summary

Objective Response Rate (ORR) of sotorasib in the all subjects treated population

Detailed description

Objective Response Rate (ORR) of sotorasib in the predefined patient groups (including ECOG PS2, specific comorbidities, including immune-related adverse events after (chemo-) immunotherapy), Progression Free Survival (PFS), Duration of Response (DoR), Disease Control Rate (DCR), Intracranial Disease Free Survival (iDFS), Intracranial Time To Recurrence (iTTR), Tumour shrinkage, Overall Survival (OS), Time on treatment post progression, Change from baseline over time to week 12 in disease related symptoms, physical functioning and global health status as measured by QLQ-C30 and QLQ-LC13, To estimate the subject incidence of treatment-emergent adverse events, treatment-related adverse events, changes in vital signs, and clinical laboratory tests, Molecular characterization (see below) of blood and tissue before commencement on sotorasib, at response and at progression on sotorasib, NGS (deep targeted sequencing of tumour tissue), STK11/LKB1, KEAP1, p53 etc, Molecular analyses (incl NGS, e.g. Avenio) of blood samples (ctDNA), Array-based microRNA, methylation, mRNA expression, Protein analyses based on IHC, including immune-markers as PD-L1, IL-10, STING, TGFbeta etc, Exploratory analyses to be determined, Intracranial Objective Response Rate (iORR), Intracranial Disease Control Rate (iDCR), Intracranial Duration of response (iDoR), Intracranial Progression Free Survival (iPFS)

Related papers

No related papers found yet.

Interventions

DRUGSOTORASIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) of sotorasib in the all subjects treated population	—

Secondary

Measure	Time frame
Objective Response Rate (ORR) of sotorasib in the predefined patient groups (including ECOG PS2, specific comorbidities, including immune-related adverse events after (chemo-) immunotherapy), Progression Free Survival (PFS), Duration of Response (DoR), Disease Control Rate (DCR), Intracranial Disease Free Survival (iDFS), Intracranial Time To Recurrence (iTTR), Tumour shrinkage, Overall Survival (OS), Time on treatment post progression, Change from baseline over time to week 12 in disease related symptoms, physical functioning and global health status as measured by QLQ-C30 and QLQ-LC13, To estimate the subject incidence of treatment-emergent adverse events, treatment-related adverse events, changes in vital signs, and clinical laboratory tests, Molecular characterization (see below) of blood and tissue before commencement on sotorasib, at response and at progression on sotorasib, NGS (deep targeted sequencing of tumour tissue), STK11/LKB1, KEAP1, p53 etc, Molecular analyses (incl NGS,	—

Measure

Time frame

Objective Response Rate (ORR) of sotorasib in the predefined patient groups (including ECOG PS2, specific comorbidities, including immune-related adverse events after (chemo-) immunotherapy), Progression Free Survival (PFS), Duration of Response (DoR), Disease Control Rate (DCR), Intracranial Disease Free Survival (iDFS), Intracranial Time To Recurrence (iTTR), Tumour shrinkage, Overall Survival (OS), Time on treatment post progression, Change from baseline over time to week 12 in disease related symptoms, physical functioning and global health status as measured by QLQ-C30 and QLQ-LC13, To estimate the subject incidence of treatment-emergent adverse events, treatment-related adverse events, changes in vital signs, and clinical laboratory tests, Molecular characterization (see below) of blood and tissue before commencement on sotorasib, at response and at progression on sotorasib, NGS (deep targeted sequencing of tumour tissue), STK11/LKB1, KEAP1, p53 etc, Molecular analyses (incl NGS,

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Countries

Denmark, Norway, Sweden

Outcome results

None listed