IFCT-2103 DIAL De-escalation Immunotherapy mAintenance duration trial for stage IV Lung cancer patients with disease control after chemo-immunotherapy induction A phase II-III randomized trial evaluating maintenance pembrolizumab (± pemetrexed) until progression versus observation (± pemetrexed) after 6 months of platinum-based doublet chemotherapy plus pembrolizumab induction treatment in patients with stage IV Non-Small Cell Lung Cancer (NSCLC)

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515945-40-00

Acronym

IFCT-2103

Enrollment

1360

Registered

2024-10-25

Start date

2022-05-02

Completion date

Unknown

Last updated

2025-05-23

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

18-month overall survival (OS) from inclusion in both arms, Overall Survival (OS) from randomization date

Detailed description

The time until definitive HRQol (Health Related Quality of Life) score deterioration, PFS from randomization at 6 months in both arms, OS according to the histological subtype squamous cell carcinoma vs. non-squamous, OS according to PD-L1 tumor level of expression in each arm, PFS from randomization at 6 months according to PD-L1 tumor level of expression in each arm

Interventions

DRUGPACLITAXEL

DRUGCISPLATIN

DRUGCARBOPLATIN

DRUGPEMBROLIZUMAB

DRUGPEMETREXED

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
18-month overall survival (OS) from inclusion in both arms, Overall Survival (OS) from randomization date	—

Secondary

Measure	Time frame
The time until definitive HRQol (Health Related Quality of Life) score deterioration, PFS from randomization at 6 months in both arms, OS according to the histological subtype squamous cell carcinoma vs. non-squamous, OS according to PD-L1 tumor level of expression in each arm, PFS from randomization at 6 months according to PD-L1 tumor level of expression in each arm	—

Countries

France

Outcome results

None listed

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