OMiT IO

A prospective, randomized study comparing chemotherapy versus
chemotherapy plus immunotherapy in patients with advanced NSCLC with TMB

Subjects are eligible to be included in the study only if all the following criteria are met:

1. Age>18years
2. Advanced, metastatic non-small cell lung cancer UICC that requires systemic
treatment (ie stage IV or stage lllb not amendable to radical local treatment)
3. ECOG PS 0-2
4. PD-L1 TPS <50% (Dako 22C3)
5. TMB <10/Mb and either actionable mutation. inactivating bi-allelic STK11 or
KEAP1 or NFE2L2 mutations as detected by NGS using OCA+ or TSO500 gene
panel or by WGS or WES
6. No prior systemic therapy except for patients with activating mutations.
7. Fit for treatment with chemo-immunotherapy deemed by the treating physician.
8. Measurable disease (RECIST 1.1).
9. In case of activating mutation, pretreatment with appropriate (i.e. guideline
recommended) targeted therapy is required with demonstrated disease progression

Subjects who meets any of the following criteria will be excluded from participation in this study:

1.Symptomatic CNS metastasis requiring immediate radiotherapy or neurosurgical
intervention.
2. Any contra-indication (as per label) for treatment with immune checkpoint
inhibitors.