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
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.
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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