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Clinical Trials/NL-OMON56597
NL-OMON56597
Not yet recruiting
Not Applicable

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

eids Universitair Medisch Centrum0 sites162 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
eids Universitair Medisch Centrum
Enrollment
162
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility 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 cTML (\<300 nonsynonymous
  • mutations) and either actionable mutation, inactivating STK11 or KEAP1
  • 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

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

Outcomes

Primary Outcomes

Not specified

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