Immunotherapy / Cemiplimab 350 mg IV / Non Small Cell Lung Cancer · Phase 2 Trial

RADICAL-IO: thRee Cycles of immunotherApy Without raDical Therapy In mediCALly InOperable Stage I Non-small Cell Lung Cancer

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 2 trial registration from the Netherlands Cancer Institute examining whether carefully selected patients with stage I non-small-cell lung cancer can achieve cure with immunotherapy (cemiplimab) monotherapy, without surgery or radiotherapy. No results are yet posted; the study is not yet recruiting.

What was studied

Phase 2, Interventional, Single Group, Open label, Treatment purpose. Non Small Cell Lung Cancer, Immunotherapy; age from 18 Years. Intervention: Three cycles of cemiplimab. n = 30. 2 sites: Netherlands.

Key findings

Safety

Effect size, safety data, and comparative efficacy versus standard of care (surgery/radiotherapy ± chemotherapy) are unknown.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an unstarted Phase 2 interventional trial with no posted results; it is a study design and rationale only, representing early-stage exploration of immunotherapy monotherapy in a selected population.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Recurrence free survival (RFS) as per RECIST 1.1 (assessed at 24 months)

DesignPhase 2, Interventional, Single Group, Open label, Treatment purpose

PopulationNon Small Cell Lung Cancer, Immunotherapy; age from 18 Years

Sample size30

InterventionThree cycles of cemiplimab

Setting2 sites: Netherlands

Reported figures

Quoted from the source exactly as published.

Planned enrollment30

PhasePhase 2

Primary outcome measureRecurrence-free survival (RFS) as per RECIST 1.1, assessed at 24 months

InterventionCemiplimab 350 mg IV

Caveats

This is a registry record only; no results are posted and recruitment has not yet begun.
Study design details (single-arm vs. comparative, patient selection criteria, cemiplimab schedule and duration) are not fully specified in the registry text.
No baseline characteristics, statistical power calculation, or secondary outcomes are reported.
Effect size, safety data, and comparative efficacy versus standard of care (surgery/radiotherapy ± chemotherapy) are unknown.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 2 interventional design with planned primary outcome; single-arm structure implied by description.

Directness

strong

Clinical outcome (recurrence-free survival at 24 months) directly relevant to curative intent in early-stage lung cancer.

Consistency

insufficient

No results reported; consistency cannot be assessed from this registry record.

Risk of bias

insufficient

Study not yet recruiting; conduct, blinding, and bias mitigation details not yet available.

Sample adequacy

limited

Planned enrollment 30 participants; small for Phase 2, no power calculation stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07808138). This is a study registration, not published results. Lead sponsor: The Netherlands Cancer Institute. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Non Small Cell Lung Cancer, Immunotherapy. Interventions: DRUG: Cemiplimab 350 mg IV. Primary outcome measures: Recurrence free survival (RFS) as per RECIST 1.1 , 24 months. Brief summary: Traditionally, chemotherapy and/or immunotherapy are combined with surgery or radiotherapy to cure patients with lung cancer. However, some patients treated with immunotherapy appear to be cured before surgery or radiotherapy. In this study, we will select patients with a high chance to respond to immunotherapy. These patients will be treated with immunotherapy alone, thereby evaluating whether these patients can be cured without surgery or radiotherapy.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07808138ImmunotherapyThe Netherlands Cancer InstituteCemiplimab 350 mg IVNon Small Cell Lung Cancer