Fiber-Boost Randomized Controlled Trial

Inclusion Criteria

• •Age ≥18 years
• •Written informed consent according to Swiss law and ICH/GCP regulations before inclusion and prior to any trial-specific procedures
• •Histologically or cytologically confirmed NSCLC
• •Advanced or recurrent NSCLC not amenable to curative treatment
• •PD-L1 expression ≥50% (TPS) determined by an approved IHC test
• •No actionable genetic alterations in genes such as EGFR, ALK, ROS1, HER2, BRAF, RET, MET, NTRK
• •First-line palliative PD-1/PD-L1-targeted monotherapy at a 3-weekly schedule indicated per local investigator
• •Willingness and ability to undergo study interventions
• •ECOG performance status 0-2
• •Adequate organ function:
• •Hemoglobin ≥70 g/L, platelet count ≥50 G/L, granulocytes ≥1 G/L
• •Bilirubin, ALT, AST ≤3 x ULN
• •Glomerular filtration rate (Cockroft-Gault) ≥30 mL/min/1.73m²
• •Measurable or evaluable disease per RECIST 1.1
• •Patients with CNS metastases are eligible, provided there is no requirement for corticosteroids as therapy for CNS disease and no evidence of clinical progression
• •Women with child-bearing potential use effective contraception (two independent methods), are not currently pregnant or lactating, and agree to not become pregnant during the trial treatment and during 3 months thereafter. A negative pregnancy test in either urine or blood is required for women with child-bearing potential before trial inclusion.
• •Men who are not sterile agree to use contraceptive methods (condoms) or abstain from sexual intercourse during the trial treatment and 3 months thereafter.