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.
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
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: Curative hypofractionated radiotherapy; Drug: 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. 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.
Progression-Free Survival (PFS)
Time from randomization to progression or death.
Measured: About 18 months
Secondary outcomes (13)
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
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
PFS at 12 months
Time from randomization to progression or death.
Measured: At 12 months
PFS at 18 months
Time from randomization to progression or death.
Measured: At 18 months
PFS at 3 year
Time from randomization to progression or death.
Measured: At 3 year
Overall Survival (OS) curve
Time from date of inclusion to the date of death due to any cause.
Measured: About 3 year
OS at 12 months
Time from date of inclusion to the date of death due to any cause.
Measured: At 12 months
OS at 18 months
Time from date of inclusion to the date of death due to any cause.
Measured: At 18 months
OS at 3 year
Time from date of inclusion to the date of death due to any cause.
Measured: At 3 year
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
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
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
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.
- First posted24 Oct 2024
- Study start7 Nov 2025
- Primary completionSep 2028 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06656598
- Acronym / sponsor ID
- SPORADIC / IFCT-2401
- Conditions
- Stage III NSCLC
- Keywords
- NSCLC, NSCLC, Stage III, Unfit or elderly patients, IFCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (neoadjuvant chemotherapy only) | Active comparator | Drug: Carboplatin, Drug: Paclitaxel, Radiation: Curative hypofractionated radiotherapy, Drug: Cemiplimab (maintenance)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. |
| Arm B (neoadjuvant chemo-immunotherapy) | Experimental | Drug: Carboplatin, Drug: Paclitaxel, Drug: Cemiplimab, Radiation: Curative hypofractionated radiotherapy, Drug: Cemiplimab (maintenance)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinNeoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks). | Drug | Arm A (neoadjuvant chemotherapy only), Arm B (neoadjuvant chemo-immunotherapy) |
| PaclitaxelNeoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks). | Drug | Arm A (neoadjuvant chemotherapy only), Arm B (neoadjuvant chemo-immunotherapy) |
| CemiplimabNeoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks). | Drug | Arm B (neoadjuvant chemo-immunotherapy) |
| Curative hypofractionated radiotherapyCurative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant treatment. | Radiation | Arm A (neoadjuvant chemotherapy only), Arm B (neoadjuvant chemo-immunotherapy) |
| Cemiplimab (maintenance)Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of radiotherapy (12 months). | Drug | Arm A (neoadjuvant chemotherapy only), Arm B (neoadjuvant chemo-immunotherapy) |
Primary outcome
Progression-Free Survival (PFS)
Time frame: About 18 months
Time from randomization to progression or death.
13 secondary outcomes
Objective Response Rate (ORR)
Time frame: About 18 months
Disease Control Rate (DCR)
Time frame: About 18 months
PFS at 12 months
Time frame: At 12 months
PFS at 18 months
Time frame: At 18 months
PFS at 3 year
Time frame: At 3 year
Overall Survival (OS) curve
Time frame: About 3 year
OS at 12 months
Time frame: At 12 months
OS at 18 months
Time frame: At 18 months
OS at 3 year
Time frame: At 3 year
Acute and late grade 3-4 toxicity rates of neoadjuvant chemoimmunotherapy before hypofractionated radiotherapy
Time frame: Up to 90 days after the end of immunotherapy
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 frame: About 18 months
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 frame: About 18 months
Acute and late grade 3-4 toxicity rates of consolidation immunotherapy
Time frame: Up to 90 days after the end of immunotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
25 sites in 1 country: see every site and its status.
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.