A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination with Standard of Care Immunotherapy in Participants with Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer

Studiedetails

Type carcinoma: NSCLC met mutatie
Stadium: II en III
Mutatie: KRAS G12C
Lijn: 2de
Site: Elisabeth-TweeSteden Ziekenhuis
Contactgegevens:

b.debruijn@etz.nl; ETZ_NL_lung_trial@etz.nl

Website:

 Inclusiecriteria

• are of an acceptable age to provide informed consent according to local regulations and are at least 18 years of age
• have confirmed NSCLC
– Part A – Stage II-IIIB cancer that has been treated with chemotherapy and surgery
– Part B – Stage III cancer that has been treated with chemotherapy and radiation
• have the status of 2 specific biomarkers, KRAS in blood or tumor samples and PD-L1 in tumor samples
• are able to perform daily activities such as light housework or office work, and
• are able to swallow oral medication.

 Exclusiecriteria

• Have one of these tumor types:
– large cell neuro-endocrine cancer
– mixed small cell and non-small cell lung cancer
– two separate NSCLCs appearing at the same time in different parts of the lungs, either on the same or opposite sides.
• Have known changes in the EGFR or ALK genes.
• Have another type of cancer that is progressing or required active treatment within the past 3 years before screening.
• Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.

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