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First-line immunotherapy-based standard of care and local ablative treatments for oligometastatic non-small cell lung cancer patients: a randomized, multicentre, open-label phase III study (OliGRAIL)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503326-39-00
Acronym
CSET N° 2023/3729
Enrollment
130
Registered
2024-11-19
Start date
2025-03-06
Completion date
Unknown
Last updated
2025-08-26

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

Conditions

Synchronous oligometastatic non-small cell lung cancer (NSCLC)

Brief summary

The primary endpoint is overall survival (OS).

Detailed description

PFS or iPFS according to RECIST 1.1 and iRECIST., Cancer specific survival., Type of relapses, local and distant control rates in both arms., Acute/ late adverse events graded by CTCAE v5 (toxic death and serious adverse events)., QoL according to EORTC QLQ-C30, QLQ-LC-13, EQ-5D-5L, Clearance rate at 6 weeks and 4 months (before maintenance) of circulating tumour DNA assessed in plasma compared to value at baseline in the 2 arms., Economic evaluation: incremental cost per Quality-adjusted life year (QALY based on EQ-5D-5L measures), incremental net monetary benefit.

Interventions

DRUGTecentriq 840 mg concentrate for solution for infusion
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
DRUGCisplatine Accord 1 mg/ml concentraat voor oplossing voor infusie
DRUGPemetrexed Accord 25 mg/ml concentrate for solution for infusion
DRUGCARBOPLATINE KABI 10 mg/ml
DRUGsolution à diluer pour perfusion
DRUGPACLITAXEL SANDOZ 6 mg/ml
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Institut Gustave Roussy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is overall survival (OS).—

Secondary

MeasureTime frame
PFS or iPFS according to RECIST 1.1 and iRECIST., Cancer specific survival., Type of relapses, local and distant control rates in both arms., Acute/ late adverse events graded by CTCAE v5 (toxic death and serious adverse events)., QoL according to EORTC QLQ-C30, QLQ-LC-13, EQ-5D-5L, Clearance rate at 6 weeks and 4 months (before maintenance) of circulating tumour DNA assessed in plasma compared to value at baseline in the 2 arms., Economic evaluation: incremental cost per Quality-adjusted life year (QALY based on EQ-5D-5L measures), incremental net monetary benefit.—

Countries

France

Outcome results

None listed

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