Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities

Sponsor
Vestre Viken Hospital Trust
Study ID
NCT05311709
Phase
PHASE2
Status
Unknown

Conditions

  • Cancer
  • Cancer, Lung
  • Lung Cancer
  • Lung Cancer Stage IV
  • Mutation
  • NSCLC Stage IV
  • NSCLC, Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sotorasib — DRUG
    single group, all patients receive sotorasib

Study Details

A single-arm, multicentre trial to investigate sotorasib in KRASG12C-mutated non-small cell lung cancer stage III/IV not amenable for curative treatment including patients with comorbidities, and to provide translational knowledge regarding mechanism of relapse and differences in responses, including differences among patients with different co-occurring mutations.

Key Dates

Start date
May 30, 2022
Status verified
Nov 2023
Primary completion
Oct 1, 2024
Completion
Mar 1, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sotorasib
    Single arm trial. All patients will be included in this interventional arm.

Primary Outcome Measure

Objective Response Rate (ORR) of sotorasib reducing tumour size in the all subjects treated [ Time Frame: every eigth week until progression, or up to 2 years ]

Central Contacts

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