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IFCT-1701 DICIPLE A randomized phase 3 trial comparing continuation Nivolumab-Ipilimumab doublet immunotherapy until progression versus observation in treatment-naive patients with stage IV Non-Small Cell Lung Cancer (NSCLC) after Nivolumab-Ipilimumab induction treatment

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514586-20-01
Acronym
IFCT-1701
Enrollment
1360
Registered
2025-01-21
Start date
2018-05-02
Completion date
2025-10-15
Last updated
2025-09-11

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

Conditions

Non small cell lung cancer

Brief summary

Progression Free Survival (PFS1)

Detailed description

Progression Free Survival (PFS2), Quality of life (QoL), Overall survival (OS), Biological correlative exploratory studies (PD-L1), Biological correlative exploratory studies (PD-L1 H score), Biological correlative exploratory studies (CD3/CD8), Biological correlative exploratory studies (neutrophil), Biological correlative exploratory studies (cytokines), Biological correlative exploratory studies (chemokines)

Interventions

DRUGYERVOY 5 mg/ml concentrate for solution for infusion
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Sponsors

Intergroupe Francophone De Cancerologie Thoracique
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression Free Survival (PFS1)

Secondary

MeasureTime frame
Progression Free Survival (PFS2), Quality of life (QoL), Overall survival (OS), Biological correlative exploratory studies (PD-L1), Biological correlative exploratory studies (PD-L1 H score), Biological correlative exploratory studies (CD3/CD8), Biological correlative exploratory studies (neutrophil), Biological correlative exploratory studies (cytokines), Biological correlative exploratory studies (chemokines)

Countries

France

Outcome results

None listed

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