Cemiplimab / Stage III NSCLC / Curative hypofractionated radiotherapy · Phase 2 Trial

Adjuvant Chemotherapy +/- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer

ClinicalTrials.gov · August 11, 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 Phase 2 trial registration for an investigational combination of adjuvant chemotherapy, cemiplimab (anti-PD-L1 monoclonal antibody), and sequential hypofractionated radiotherapy in elderly or unfit patients with stage III NSCLC. No results are posted in this registry record; the study is currently recruiting participants and primary outcome data (18-month PFS) are not yet available.

What was studied

Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Stage III NSCLC; age from 18 Years. Intervention: Arm B (neoadjuvant chemo-immunotherapy). Compared with: Arm A (neoadjuvant chemotherapy only) — Active Comparator. n = 152. 25 sites: France.

Key findings

Safety

No efficacy or safety results are available; study is still recruiting.

Who this may help

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

Plain-language summary

This is a Phase 2 interventional trial registration with no results posted; the study is actively recruiting and outcome data are not yet available.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Progression-Free Survival (PFS) (assessed at About 18 months)

DesignPhase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationStage III NSCLC; age from 18 Years

Sample size152

InterventionArm B (neoadjuvant chemo-immunotherapy)

ComparatorArm A (neoadjuvant chemotherapy only) — Active Comparator

Setting25 sites: France

Reported figures

Quoted from the source exactly as published.

Planned enrollment152

Primary outcome measureProgression-Free Survival

Primary outcome timeframeAbout 18 months

Study phasePhase 2

Caveats

This is a trial registration, not published results; no outcome data are reported.
Study arms and comparator structure are not clearly specified in the registry record.
Blinding, randomization method, and allocation concealment are not described.
No efficacy or safety results are available; study is still recruiting.

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; single-arm or comparison structure not clearly specified in registry record.

Directness

insufficient

Registry record does not describe comparator groups or study arms in sufficient detail.

Consistency

insufficient

No results reported; consistency with other evidence cannot be assessed from this record.

Risk of bias

insufficient

Study design, blinding, and allocation methods not described in registry record.

Sample adequacy

limited

Estimated enrollment 152 participants; adequate for Phase 2 but study is still recruiting.

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 (NCT06656598). This is a study registration, not published results. Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 152 participants (ESTIMATED). Conditions: Stage III NSCLC. Interventions: DRUG: Carboplatin; DRUG: Paclitaxel; DRUG: Cemiplimab; RADIATION: Curative hypofractionated radiotherapy; DRUG: Cemiplimab (maintenance). Primary outcome measures: Progression-Free Survival (PFS) , About 18 months. Brief summary: The use of neoadjuvant immuno-chemotherapy could improve survival outcomes of patients eligible for sequential radio-chemotherapy comparing to the benefit already obtained with maintenance immunotherapy.

Follow from this

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

CemiplimabStage III NSCLCIntergroupe Francophone de Cancerologie ThoraciqueCurative hypofractionated radiotherapyCarboplatinNCT06656598Paclitaxel