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Immune-modulatory radiotherapy to enhance the effects of neoadjuvant PD-L1 blockade after neoadjuvant chemotherapy in patients with resectable stage III(N2) non-small cell lung cancer (NSCLC). A multicenter phase II trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504536-18-00
Acronym
SAKK 16/18
Enrollment
10
Registered
2024-04-17
Start date
2024-07-31
Completion date
Unknown
Last updated
2025-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable, locally advanced non-small cell lung cancer (NSCLC, N2)

Brief summary

Event-free survival (EFS) at 12 months

Detailed description

Event-free survival (EFS), Recurrence-free survival (RFS) after R0 resection, Overall survival (OS), Objective response (OR) after neoadjuvant chemotherapy, OR after neoadjuvant immunotherapy and immune-modulatory radiotherapy, Pathological complete response (pCR), Local major pathological response (MPR), Overall major pathological response (oMPR), Rate of nodal down-staging to < ypN2, Complete resection rate, Pattern of recurrence (loco-regional, distant), Adverse events (AEs) and surgical complications, Delay in surgery, Postoperative 30-day mortality

Interventions

DRUGCarboplat onkovis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGPaclitaxel onkovis
DRUG6 mg/ml
DRUGKonzentrat zur Herstellung einer Infusionslösung
DRUGDoce onkovis 20 mg/ ml Konzentrat zur Herstellung einer Infusionslösung
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGPemetrexed medac 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
DRUGVinorelbin onkovis 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGPemetrexed medac 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
DRUGCisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Sponsors

Swiss Group for Clinical Cancer Research
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Event-free survival (EFS) at 12 months—

Secondary

MeasureTime frame
Event-free survival (EFS), Recurrence-free survival (RFS) after R0 resection, Overall survival (OS), Objective response (OR) after neoadjuvant chemotherapy, OR after neoadjuvant immunotherapy and immune-modulatory radiotherapy, Pathological complete response (pCR), Local major pathological response (MPR), Overall major pathological response (oMPR), Rate of nodal down-staging to < ypN2, Complete resection rate, Pattern of recurrence (loco-regional, distant), Adverse events (AEs) and surgical complications, Delay in surgery, Postoperative 30-day mortality—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026