NCT06656598

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for phase_2

Timeline
69mo left

Started Nov 2025

Longer than P75 for phase_2

Geographic Reach
1 country

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Nov 2025Jan 2032

First Submitted

Initial submission to the registry

October 9, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

November 7, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

October 9, 2024

Last Update Submit

February 9, 2026

Conditions

Stage III NSCLC

Keywords

NSCLCNSCLC, Stage IIIUnfit or elderly patientsIFCT

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    Time from randomization to progression or death.

    About 18 months

Secondary Outcomes (12)

  • Objective Response Rate (ORR)

    About 18 months

  • Disease Control Rate (DCR)

    About 18 months

  • PFS at 12 months

    At 12 months

  • PFS at 18 months

    At 18 months

  • PFS at 3 year

    At 3 year

  • +7 more secondary outcomes

Study Arms (2)

Arm A (neoadjuvant chemotherapy only)

ACTIVE COMPARATOR

Patients will receive neoadjuvant chemotherapy alone with carboplatin AUC 5 D1 and paclitaxel 80mg/m² D1 D8 D15 (3 cycles of 4 weeks). Patients will subsequently receive curative hypofractionated radiotherapy (55 Gy/20fr). After radiotherapy, patients will receive maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks for a period of 12 months.

Drug: CarboplatinDrug: PaclitaxelRadiation: Curative hypofractionated radiotherapyDrug: Cemiplimab (maintenance)

Arm B (neoadjuvant chemo-immunotherapy)

EXPERIMENTAL

Patients will receive neoadjuvant chemotherapy alone with carboplatin AUC 5 D1 and paclitaxel 80mg/m² D1 D8 D15 and cemiplimab 350 mg D1-D21 (3 cycles of 4 weeks). Patients will subsequently receive curative hypofractionated radiotherapy (55 Gy/20fr). After radiotherapy, patients will receive maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks for a period of 12 months.

Drug: CarboplatinDrug: PaclitaxelDrug: CemiplimabRadiation: Curative hypofractionated radiotherapyDrug: Cemiplimab (maintenance)

Interventions

PaclitaxelDRUG

Neoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks).

Arm A (neoadjuvant chemotherapy only)Arm B (neoadjuvant chemo-immunotherapy)
CemiplimabDRUG

Neoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks).

Arm B (neoadjuvant chemo-immunotherapy)
Cemiplimab (maintenance)DRUG

Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of radiotherapy (12 months).

Arm A (neoadjuvant chemotherapy only)Arm B (neoadjuvant chemo-immunotherapy)
CarboplatinDRUG

Neoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks).

Arm A (neoadjuvant chemotherapy only)Arm B (neoadjuvant chemo-immunotherapy)
Curative hypofractionated radiotherapyRADIATION

Curative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant treatment.

Arm A (neoadjuvant chemotherapy only)Arm B (neoadjuvant chemo-immunotherapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
  • Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
  • Age ≥ 18 years.
  • Histologically or cytologically confirmed locally advanced non small cell lung cancer (NSCLC) stage IIIA non resectable, IIIB or IIIC accordingly to 8th classification TNM, UICC 2015.
  • Patients over 70 years of age with Eastern Cooperative Oncology Group Performance Status (ECOG PS) PS of 0 to 1.
  • Or Patients under 70 years of age with ECOG PS of 0 to 1 and a score ≥ 3 according to the Charlson comorbidity criterion or ECOG PS 2.
  • Patients eligible for treatment with sequential radio-chemotherapy validated by multidisciplinary committee.
  • Measurable disease according to RECIST 1.1.
  • Respiratory function:
  • FEV1 ≥ 40% of theoretical value,
  • DLCO ≥ 40%.
  • Bone marrow function:
  • absolute neutrophil count (ANC) ≥ 1.5.109/L,
  • platelets ≥ 100.109/L,
  • hemoglobin ≥ 9 g/dl.
  • +7 more criteria

You may not qualify if:

  • Immunotherapy or chemotherapy contra-indicated.
  • Patients eligible for treatment with concomitant radio-chemotherapy validated by multidisciplinary committee.
  • Stage I or II NSCLC.
  • Previously received a treatment with anti-PD1/PDL1, anti-CTLA, or other antineoplastic immunotherapy or chemotherapy for NSCLC.
  • Histology other than primary non-small cell lung cancer.
  • Patients with an activating EGFR mutation or ALK or ROS1 translocation.
  • Metastatic NSCLC including brain metastasis.
  • Patients not eligible for curative radiotherapy (tumor extension, predictable dose constraints that cannot be met).
  • Severe uncontrolled comorbidities or severe intercurrent disease: acute coronary syndrome less than 3 months old, unstable angina, heart failure with LVEF ≤30%, uncontrolled hypertension, Child B or C cirrhosis, severe sepsis, myocarditis or any other active conditions that would contraindicate chemotherapy, immunotherapy, or radiotherapy in the opinion of the investigator.
  • Weight loss ≥15% of total body weight in the last 6 months.
  • ECOG PS upper 2
  • Active autoimmune pathology. History of autoimmune pathology including myasthenia, Guillain-Barre syndrome, lupus erythematosus, antiphospholipid syndrome, Wegener's granulomatosis, glomerulonephritis, inflammatory bowel disease, vasculitis, sarcoidosis, uveitis. Autoimmune thyroid pathologies under replacement therapy as well as type 1 diabetes under insulin are authorized.
  • History of idiopathic pulmonary fibrosis, organized pneumopathy or signs of active interstitial pulmonary pathology on CT scan.
  • Any immunosuppressive therapy received within 28 days and corticosteroids \> 10mg/day of prednisone or equivalent received within 7 days prior the start of chemotherapy excepted hydrocortisone replacement for adrenal insufficiency or pituitary disease not considered immunosuppressive therapy.
  • Chronic active infection including tuberculosis, HIV, hepatitis B (HBsAg positive) or C. Patients with a history of cured hepatitis B (anti HBc and absence of negative HBs antigen) are eligible. In case of hepatitis C (anti HCV Ac) patients are eligible if the HCV PCR is negative.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Angers - Centre Paul Papin

Angers, France

RECRUITING

Angers - CHU

Angers, France

RECRUITING

Avignon - CH

Avignon, France

RECRUITING

Boulogne - Ambroise Paré

Boulogne, France

RECRUITING

Brest - CHU

Brest, France

RECRUITING

Caen - CHU

Caen, France

RECRUITING

Caen - CRLCC

Caen, France

RECRUITING

Créteil - CHI

Créteil, France

RECRUITING

Dijon - CRLCC

Dijon, France

RECRUITING

Le Mans - CHG

Le Mans, France

RECRUITING

Lille - CRLCC

Lille, France

RECRUITING

Marseille - APHM

Marseille, France

RECRUITING

Mulhouse - GHRMSA

Mulhouse, France

RECRUITING

Paris - Bichat

Paris, France

RECRUITING

Paris - Hôpital Cochin

Paris, France

RECRUITING

Paris - Tenon

Paris, France

RECRUITING

Bordeaux - CHU

Pessac, France

RECRUITING

Lyon - HCL

Pierre-Bénite, France

RECRUITING

Rennes - CHU

Rennes, France

RECRUITING

Rouen - Centre Henri Becquerel

Rouen, France

RECRUITING

Nantes - CRLCC

Saint-Herblain, France

RECRUITING

Strasbourg - CRLCC

Strasbourg, France

RECRUITING

Toulouse - CHU

Toulouse, France

RECRUITING

Tours - CHU

Tours, France

RECRUITING

Vandoeuvre-lès-Nancy - CRLCC

Vandœuvre-lès-Nancy, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CarboplatinPaclitaxelcemiplimabMaintenance

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesHealth Care Facilities Workforce and Services

Central Study Contacts

Contact IFCT

CONTACT

+33 1.56.81.10.45contact@ifct.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 24, 2024

Study Start

November 7, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

January 1, 2032

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

FR(25)