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.
Meer studies
Een overzicht van alle lopende studies binnen het longkankernetwerk. Filter op type mutatie:
TroFuse-007
1e lijn | Stadium IV | NSCLC zonder mutatie
Tiger MESO
1ste lijn | Stadium IV
SUNRAY-02
2e lijn | Stadium II en III | KRASG12C mutatie
SUNRAY-01
1e lijn | Stadium IIIB-IIIC of IV | KRASG12C mutatie
SATIN
Stadium IV
ROSETTA Lung-202
1e lijn | stadium III-IV
RASolve 301
2e lijn | IIIB of IV | RAS mutatie
PADLINK-005 (Pfizer/SGNPDL1V)
2e lijn | stadium III or metastatic IV |
OSIBOOST 2
2e lijn | Stadium IV | EGFR mutatie
OSI-SAVE
1e lijn | stadium III-IV | EGFR mutatie
OMiT IO
1ste lijn | stadium IIIb or IV |
NEOpredict-EGFR
2e lijn | Stadium IB, II of selected IIIA | EGFR mutatie
MK-2870
2e lijn | Stadium II, IIIB |
KANDLELIT-007
1e lijn | stadium III-IV | KRAS mutatie
INTerpath-014
1e lijn | stadium I |
IDeate-Lung02
2e lijn | Stadium IV |
Ensure
1ste lijn | Stadium I-IIIA
DAREON-Lung-1
1e lijn | stadium III-IV |
CUP/EAP/DAP/DRUP
Lijst van verschillende programma's
CodeBreaK 202
1e lijn | Stadium IV | KRASG12C mutatie
CARMEN-LC03
2de/3de lijn | Stadium III-IV
BNT327-003
1e lijn | stadium IV |
ARTEMIA
2e lijns | Stadium IV | KRAS en BRAF en NSCLC zonder mutatie
Adapt Alec
1e en 2e lijn | III-IV | ALK mutatie

