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%.
- Conditions
- non-small cell lung cancer10038666
- Registration Number
- NL-OMON56597
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 162
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.
1. Symptomatic CNS metastasis requiring immediate radiotherapy or neurosurgical
intervention.
2. Any contra-indication (as per label) for treatment with immune checkpoint
inhibitors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method