AzTrials
AzTrials

Stage III NSCLCPhase 2SPORADICNCT06656598

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

A Phase 2 study testing Carboplatin, Paclitaxel and Cemiplimab in people with Stage III NSCLC, run by Intergroupe Francophone de Cancerologie Thoracique at 25 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage III NSCLC
What is being tested?
Carboplatin, Paclitaxel and Cemiplimab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
25 sitesFrance
Study dates
7 Nov 2025to Jan 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Unfit or elderly patients as defined below:
  • ≥ 70 years , PS 0 to 1, charlson comorbidity criterion : all score
Show all 25Show fewer
  • < 70 years , PS 0 to 1, charlson comorbidity criterion : score ≥ 3
  • < 70 years , PS , charlson comorbidity criterion : all score
  • Patients eligible for treatment with sequential radio-chemotherapy validated by multidisciplinary committee.
  • Measurable disease according to RECIST 1.1 per investigator assessment. The radiological assessment has to be done within the timelines indicated.
  • 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.
  • Renal and hepatic function:
  • estimated creatinine clearance ≥ 45 ml/min,
  • bilirubin ≤1.5xULN,
  • AST ALT ≤3xULN,
  • Albumin ≥28g/dl.
  • Participant has national health insurance coverage.
  • Effective method of contraception during the treatment and during the 6 months following the last dose for patients of childbearing potential and for male subjects who are sexually active with a woman of childbearing potential.
  • Expression of PD-L1 as assessed locally by the investigator center.

Who cannot join

  • 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.
  • Known activating EGFR mutation or ALK or ROS1 translocation.
Show all 26Show fewer
  • 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.
  • Severe infections (including covid-19 infection) within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
  • History of neoplastic disease (other than NSCLC) less than 3 years old or progressive (except basal cell carcinoma of the skin and carcinoma in situ of the cervix).
  • History of thoracic radiotherapy.
  • Live attenuated vaccine received within 28 days of starting chemotherapy
  • History of organ or bone marrow transplantation.
  • Major surgery within 4 weeks of starting treatment.
  • Patient already included in another therapeutic trial.
  • Positive pregnancy test or breastfeeding woman.
  • Protected adults (under guardianship or curatorship).
  • Inability to undergo medical monitoring of the study (for geographical, social and/or physical reasons).
  • Patients unable to understand the study.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

25 sites in 1 country

France25 sites, 25 recruiting
  • Angers - Centre Paul Papin

    Angers

    Frédéric BIGOT, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Frédéric BIGOT, Dr

    Recruiting
  • Angers - CHU

    Angers

    Youssef OULKHOUIR, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Youssef OULKHOUIR, Dr

    Recruiting
  • Avignon - CH

    Avignon

    Nicolas POUREL, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Nicolas POUREL, Dr

    Recruiting
  • Boulogne - Ambroise Paré

    Boulogne

    Etienne GIROUX LEPRIEUR, Pr, +33 1.56.81.10.45, contact@ifct.fr

    Etienne GIROUX LEPRIEUR, Pr

    Recruiting
  • Brest - CHU

    Brest

    François LUCIA, Dr, +33 1.56.81.10.45, contact@ifct.fr

    François LUCIA, Dr

    Recruiting
  • Caen - CHU

    Caen

    Jeannick MADELAINE, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Jeannick MADELAINE, Dr

    Recruiting
  • Caen - CRLCC

    Caen

    Hubert CURCIO, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Hubert CURCIO, Dr

    Recruiting
  • Créteil - CHI

    Créteil

    Jean Bernard AULIAC, Pr, +33 1.56.81.10.45, contact@ifct.fr

    Jean Bernard AULIAC, Pr

    Recruiting
  • Dijon - CRLCC

    Dijon

    Etienne MARTIN, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Etienne MARTIN, Dr

    Recruiting
  • Le Mans - CHG

    Le Mans

    Olivier MOLINIER, Dr, 33 1.56.81.10.45, contact@ifct.fr

    Olivier MOLINIER, Dr

    Recruiting
  • Lille - CRLCC

    Lille

    Florence LE TINIER, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Florence LE TINIER, Dr

    Recruiting
  • Marseille - APHM

    Marseille

    Laurent GREILLIER, Pr, +33 1.56.81.10.45, contact@ifct.fr

    Laurent GREILLIER, Pr

    Recruiting
  • Mulhouse - GHRMSA

    Mulhouse

    Didier DEBIEUVRE, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Didier DEBIEUVRE, Dr

    Recruiting
  • Paris - Bichat

    Paris

    Valérie GOUNANT, Pr, +33 1.56.81.10.45, contact@ifct.fr

    Valérie GOUNANT, Pr

    Recruiting
  • Paris - Hôpital Cochin

    Paris

    Marie WISLEZ, Pr, +33 1.56.81.10.45, contact@ifct.fr

    Marie WISLEZ, Pr

    Recruiting
  • Paris - Tenon

    Paris

    Eleonor RIVIN DEL CAMPO, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Eleonor RIVIN DEL CAMPO, Dr

    Recruiting
  • Bordeaux - CHU

    Pessac

    Claire BARDEL, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Claire BARDEL, Dr

    Recruiting
  • Lyon - HCL

    Pierre-Bénite

    Sébastien COURAUD, Pr, +33 1.56.81.10.45, contact@ifct.fr

    Sébastien COURAUD, Pr

    Recruiting
  • Rennes - CHU

    Rennes

    Charles RICORDEL, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Charles RICORDEL, Dr

    Recruiting
  • Rouen - Centre Henri Becquerel

    Rouen

    Sébastien THUREAU, Pr, +33 1.56.81.10.45, contact@ifct.fr

    Sébastien THUREAU, Pr

    Recruiting
  • Nantes - CRLCC

    Saint-Herblain

    Judith RAIMBOURG, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Judith RAIMBOURG, Dr

    Recruiting
  • Strasbourg - CRLCC

    Strasbourg

    Delphine ANTONI, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Delphine ANTONI, Dr

    Recruiting
  • Toulouse - CHU

    Toulouse

    Julien MAZIERES, Pr, +33 1.56.81.10.45, contact@ifct.fr

    Julien MAZIERES, Pr

    Recruiting
  • Tours - CHU

    Tours

    Delphine CARMIER, Dr, +331.56.81.10.45, contact@ifct.fr

    Delphine CARMIER, Dr

    Recruiting
  • Vandoeuvre-lès-Nancy - CRLCC

    Vandœuvre-lès-Nancy

    Jean-Christophe FAIVRE, Dr, +33 1.56.81.10.45, contact@ifct.fr

    Jean-Christophe FAIVRE, Dr

    Recruiting

Other trials in France

About this study

Official title: A Multicenter Randomized Open Label Phase II Study Evaluating the Efficacy and the Tolerance of Adding Cemiplimab to Sequential hyPOfractionated chemoRADiotherapy in Unfit or Elderly Patients With Unresectable Stage III Non-small Cell Lung Cancer

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.

Conditions
Stage III NSCLC
Being tested
Carboplatin, Paclitaxel, Cemiplimab, Curative hypofractionated radiotherapy, Cemiplimab (maintenance)
Keywords
NSCLC, NSCLC, Stage III, Unfit or elderly patients, IFCT
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

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

  • PaclitaxelDrug

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

  • CemiplimabDrug

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

  • Curative hypofractionated radiotherapyRadiation

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

  • Cemiplimab (maintenance)Drug

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

Study groups in NCT06656598
Study groupRoleWhat they receive
Arm A (neoadjuvant chemotherapy only)Active comparatorPatients 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.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: Curative hypofractionated radiotherapy; Drug: Cemiplimab (maintenance)
Arm B (neoadjuvant chemo-immunotherapy)ExperimentalPatients 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.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Cemiplimab; Radiation: Curative hypofractionated radiotherapy; Drug: Cemiplimab (maintenance)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Time from randomization to progression or death.

    Measured: About 18 months

Secondary outcomes (13)
  1. Objective Response Rate (ORR)

    Proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR)

    Measured: About 18 months

  2. Disease Control Rate (DCR)

    Proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR) or stable disease (SD)

    Measured: About 18 months

  3. PFS at 12 months

    Time from randomization to progression or death.

    Measured: At 12 months

  4. PFS at 18 months

    Time from randomization to progression or death.

    Measured: At 18 months

  5. PFS at 3 year

    Time from randomization to progression or death.

    Measured: At 3 year

  6. Overall Survival (OS) curve

    Time from date of inclusion to the date of death due to any cause.

    Measured: About 3 year

  7. OS at 12 months

    Time from date of inclusion to the date of death due to any cause.

    Measured: At 12 months

  8. OS at 18 months

    Time from date of inclusion to the date of death due to any cause.

    Measured: At 18 months

  9. OS at 3 year

    Time from date of inclusion to the date of death due to any cause.

    Measured: At 3 year

  10. Acute and late grade 3-4 toxicity rates of neoadjuvant chemoimmunotherapy before hypofractionated radiotherapy

    Acute and late grade 3-4 toxicity rates by treatment arm according to CTCAE v5.0 up to 90 days after the end of immunotherapy.

    Measured: Up to 90 days after the end of immunotherapy

  11. To evaluate the quality of life of patients receiving neoadjuvant chemoimmunotherapy before hypofractionated radiotherapy with questionnaire EORTC Quality of Life Questionnaire - Core C30 (QLQ-C30)

    Time to symptom deterioration will be defined as the time from inclusion until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the subject withdraws from therapy or receives another anticancer therapy prior to symptom deterioration.

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core Questionnaire C30 (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.

    Scale : Not at all / A little / Quite a bit / Very much

    Measured: About 18 months

  12. To evaluate the quality of life of patients receiving neoadjuvant chemoimmunotherapy before hypofractionated radiotherapy with questionnaire EORTC Quality of Life Questionnaire - Lung Cancer LC29 (QLQ-LC29).

    Time to symptom deterioration will be defined as the time from inclusion until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the subject withdraws from therapy or receives another anticancer therapy prior to symptom deterioration.

    The EORTC QLQ-LC29 incorporates 5 multi-item scales to assess symptom or quality of life issues.

    Scale : Not at all / A little / Quite a bit / Very much

    Measured: About 18 months

  13. Acute and late grade 3-4 toxicity rates of consolidation immunotherapy

    Acute and late grade 3-4 toxicity rates by treatment arm according to CTCAE v5.0 up to 90 days after the end of immunotherapy.

    Measured: Up to 90 days after the end of immunotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start7 Nov 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionJan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656598
Sponsor's protocol ID
IFCT-2401
Acronym
SPORADIC
Status last verified
May 2026
First submitted
9 Oct 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Paclitaxel and Cemiplimab in people with Stage III NSCLC, run by Intergroupe Francophone de Cancerologie Thoracique at 25 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact IFCT (+33 1.56.81.10.45, contact@ifct.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: About 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in