CA209-759: Blood-borne biomarkers for tumor response to Nivolumab in KRAS-mutated non-small cell lung cancer

Conditions: on-small cell lung cancer, KRAS mutationNiet-kleincellig longkanker, KRAS mutatie

Registration Number: NL-OMON25545

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1.Histologically confirmed stage IIIB and stage IV NSCLC KRAS positive tumors only. Tumor mutation analyzed by next generation sequencing for specific KRAS mutation.

2.The tumor tissue sample must be fresh, preferably fresh frozen, in addition to routine FFPE-tissue processing from the primary tumor, core needle biopsy, excisional or incisional biopsies are accepted. Fine needle biopsies and drainage of pleural effusions with cytospins are considered adequate for this biomarker study, but a KRAS mutation must be present and verified.

Exclusion Criteria

1.Previous treatment with PD-1 or PD-L1 inhibitor.

2.Lung cancer previously treated for an ALK translocation, EGFR mutation or BRAF mutation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To discriminate, early in treatment, responders from non-responders to nivolumab in KRAS positive NSCLC.

Secondary Outcome Measures

Name	Time	Method
-Tumor response according RECIST1.1 <br /><br>-To test (blood-borne and stool) biomarkers during nivolumab treatment to explore the predictive value for early tumor response (with one year survival as readout of response).<br /><br>-To develop a simple, affordable, diagnostic test using these data that can be rapidly adopted in clinical practice (e.g. ctDNA as biomarker in blood, calprotectin level in both stool and serum, peptides shared between the microbiota and the tumor that are identified by 16s RNA sequencing at baseline, serum IL-8, CRP, I-FABP, endotoxin and CRP-levels, or a combination).