A prospective, randomized study comparing chemotherapy versus chemotherapy plus immunotherapy in patients with advanced non-small cell lung cancer with low TMB and oncogenic driver, STK11, KEAP1 or NFE2L2 mutation and a PD-L1 TPS

A prospective, randomized study comparing chemotherapy versus chemotherapy plus immunotherapy in patients with advanced non-small cell lung cancer with low TMB and oncogenic driver, STK11, KEAP1 or NFE2L2 mutation and a PD-L1 TPS<50%. OMIT IO study. - OMIT IO

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56597

Enrollment

162

Registered

2023-08-16

Start date

2025-02-10

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Patients will receive carboplatin-pemetrexed-pembrolizumab according to the KN189 regimen or the same dose and schedule of carboplatin-pemetrexed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. Advanced, metastatic non-small cell lung cancer UICC stage  IV 3. ECOG PS 0-2 4. PDL-1 TPS <50% (Dako 22C3) 5. Low TMB and either actionable mutation, inactivating STK11, KEAP1 or NFE2L2 mutations as detected by NGS using OCA+ or TSO500 gene panel. 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Objective response rate	—

Secondary

Measure	Time frame
Clinical benefit rate (defined as the proportion of patients with CR/PR + SD), progression free survival (PFS), overall survival (OS)	—

Countries

Netherlands

Contacts

Public ContactL.H.N. Schonewille

Leids Universitair Medisch Centrum

l.h.n.schonewille@lumc.nl0715264482

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026