Studieoverzicht

Study name: A prospective, randomized study comparing chemotherapy versus chemotherapy plus Immunotherapy in patients with advanced non-small cell lung cancer with TMB<10/IVIb and oncogenic driver, STK11, KEAP1 or NFE2L2 mutation. OMIT lO

Histology	NSCLC, all subtypes
Tumor stage	Stage III - IV
Host / recruiting site 1	LUMC	Enrollment	Recruiting
Host / recruiting site 2	Radboud UMC	Enrollment	Recruiting
Host / recruiting site 3	UMC Utrecht	Enrollment	Recruiting
Host / recruiting site 4	Erasmus MC	Enrollment	Recruiting
Host / recruiting site 5	UMC Groningen	Enrollment	Recruiting
Therapy line	First line (1L)
PD-L1 expression	Negative: <1%Low: 1 - 49%
Design	A multicenter, randomized, controlled, prospectieve, Phase II study designed to compare the objective response rate between patients with advanced non-small cell lung cancer characterized by PD-L1 TPS < 50% and TMB < 10/Mb and either an actionable mutation, bi-allelic inactivating STK11, KEAP1 or NFE2L2 mutations, treated by either chemo-immunotherapy or chemotherapy alone.
Intervention	Subjects will be randomized to receive either: Chemo-immunotherapy Chemotherapy
Key outcome parameters	Effectiviteit van alleen chemotherapie versus chemo-immunotherapie, primaire uitkomst ORR. Secundaire uitkomst PFS en OS
Key inclusion criteria	Age > 18 years Advanced, metastatic NSCLC that requires systemic treatment ECOG PS 0-2 PD-L1 TPS <50% TMB <10/Mb en STK11 of KEAP1 of oncogene driver mutatie No prior systemic therapy except for patients with activating mutations. Fit for treatment with chemo-immunotherapy deemed by the treating physician. Measurable disease (RECIST 1.1). In case of activating mutation, pretreatment with appropriate targeted therapy is required with demonstrated disease progression.
Key exclusion criteria	Symptomatische CNS metastasen requiring immediate radiotherapy or neurosurgical intervention. Any contra-indication for treatment with immune checkpoint inhibitors.
Contact information	Log in voor de contactinformatie