Trial Title:
Study Evaluating the Efficacy and the Tolerance of Immunochemotherapy and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients with Stage III Lung Cancer
NCT ID:
NCT06656598
Condition:
Stage III NSCLC
Conditions: Official terms:
Paclitaxel
Carboplatin
Cemiplimab
Conditions: Keywords:
NSCLC
NSCLC, Stage III
Unfit or elderly patients
IFCT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Neoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks).
Arm group label:
Arm A (neoadjuvant chemotherapy only)
Arm group label:
Arm B (neoadjuvant chemo-immunotherapy)
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Neoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks).
Arm group label:
Arm A (neoadjuvant chemotherapy only)
Arm group label:
Arm B (neoadjuvant chemo-immunotherapy)
Intervention type:
Drug
Intervention name:
Cemiplimab
Description:
Neoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks).
Arm group label:
Arm B (neoadjuvant chemo-immunotherapy)
Intervention type:
Radiation
Intervention name:
Curative hypofractionated radiotherapy
Description:
Curative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant
treatment.
Arm group label:
Arm A (neoadjuvant chemotherapy only)
Arm group label:
Arm B (neoadjuvant chemo-immunotherapy)
Intervention type:
Drug
Intervention name:
Cemiplimab (maintenance)
Description:
Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of
radiotherapy (12 months).
Arm group label:
Arm A (neoadjuvant chemotherapy only)
Arm group label:
Arm B (neoadjuvant chemo-immunotherapy)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Patients must be willing and able to comply with scheduled visits, treatment
schedule, and laboratory testing.
3. Age ≥ 18 years.
4. 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.
5. 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.
6. Patients eligible for treatment with sequential radio-chemotherapy validated by
multidisciplinary committee.
7. Measurable disease according to RECIST 1.1.
8. Respiratory function:
- FEV1 ≥ 40% of theoretical value,
- DLCO ≥ 40%.
9. Bone marrow function:
- absolute neutrophil count (ANC) ≥ 1.5.109/L,
- platelets ≥ 100.109/L,
- hemoglobin ≥ 9 g/dl.
10. Renal and hepatic function:
- estimated creatinine clearance ≥ 45 ml/min,
- bilirubin ≤1.5xULN,
- AST ALT ≤3xULN,
- Albumin ≥28g/dl.
11. Participant has national health insurance coverage.
12. 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.
Exclusion Criteria:
1. Immunotherapy or chemotherapy contra-indicated.
2. Patients eligible for treatment with concomitant radio-chemotherapy validated by
multidisciplinary committee.
3. Stage I or II NSCLC.
4. Previously received a treatment with anti-PD1/PDL1, anti-CTLA, or other
antineoplastic immunotherapy or chemotherapy for NSCLC.
5. Histology other than primary non-small cell lung cancer.
6. Patients with an activating EGFR mutation or ALK or ROS1 translocation.
7. Metastatic NSCLC including brain metastasis.
8. Patients not eligible for curative radiotherapy (tumor extension, predictable dose
constraints that cannot be met).
9. 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.
10. Weight loss ≥15% of total body weight in the last 6 months.
11. ECOG PS upper 2
12. 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.
13. History of idiopathic pulmonary fibrosis, organized pneumopathy or signs of active
interstitial pulmonary pathology on CT scan.
14. 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.
15. 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.
16. 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.
17. History of neoplastic disease less than 3 years old or progressive (except basal
cell carcinoma of the skin and carcinoma in situ of the uterus).
18. History of thoracic radiotherapy.
19. Live attenuated vaccine received within 28 days of starting chemotherapy
20. History of organ or bone marrow transplantation.
21. Major surgery within 4 weeks of starting treatment.
22. Patient already included in another therapeutic trial.
23. Positive pregnancy test or breastfeeding woman.
24. Protected adults (under guardianship or curatorship).
25. Inability to undergo medical monitoring of the study (for geographical, social
and/or physical reasons).
26. Patients unable to understand the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Angers - Centre Paul Papin
Address:
City:
Angers
Country:
France
Contact:
Last name:
Frédéric BIGOT, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Frédéric BIGOT, Dr
Facility:
Name:
Angers - CHU
Address:
City:
Angers
Country:
France
Contact:
Last name:
Youssef OULKHOUIR, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Youssef OULKHOUIR, Dr
Facility:
Name:
Avignon - CH
Address:
City:
Avignon
Country:
France
Contact:
Last name:
Nicolas POUREL, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Nicolas POUREL, Dr
Facility:
Name:
Boulogne - Ambroise Paré
Address:
City:
Boulogne
Country:
France
Contact:
Last name:
Etienne GIROUX LEPRIEUR, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Etienne GIROUX LEPRIEUR, Pr
Facility:
Name:
Brest - CHU
Address:
City:
Brest
Country:
France
Contact:
Last name:
François LUCIA, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
François LUCIA, Dr
Facility:
Name:
Caen - CHU
Address:
City:
Caen
Country:
France
Contact:
Last name:
Jeannick MADELAINE, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Jeannick MADELAINE, Dr
Facility:
Name:
Caen - CRLCC
Address:
City:
Caen
Country:
France
Contact:
Last name:
Hubert CURCIO, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Hubert CURCIO, Dr
Facility:
Name:
Créteil - CHI
Address:
City:
Créteil
Country:
France
Contact:
Last name:
Jean Bernard AULIAC, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Jean Bernard AULIAC, Pr
Facility:
Name:
Dijon - CRLCC
Address:
City:
Dijon
Country:
France
Contact:
Last name:
Etienne MARTIN, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Etienne MARTIN, Dr
Facility:
Name:
Le Mans - CHG
Address:
City:
Le Mans
Country:
France
Contact:
Last name:
Olivier MOLINIER, Dr
Phone:
33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Olivier MOLINIER, Dr
Facility:
Name:
Lille - CRLCC
Address:
City:
Lille
Country:
France
Contact:
Last name:
Florence LE TINIER, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Florence LE TINIER, Dr
Facility:
Name:
Marseille - APHM
Address:
City:
Marseille
Country:
France
Contact:
Last name:
Laurent GREILLIER, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Laurent GREILLIER, Pr
Facility:
Name:
Mulhouse - GHRMSA
Address:
City:
Mulhouse
Country:
France
Contact:
Last name:
Didier DEBIEUVRE, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Didier DEBIEUVRE, Dr
Facility:
Name:
Paris - Bichat
Address:
City:
Paris
Country:
France
Contact:
Last name:
Valérie GOUNANT, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Valérie GOUNANT, Pr
Facility:
Name:
Paris - Hôpital Cochin
Address:
City:
Paris
Country:
France
Contact:
Last name:
Marie WISLEZ, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Marie WISLEZ, Pr
Facility:
Name:
Paris - Tenon
Address:
City:
Paris
Country:
France
Contact:
Last name:
Eleonor RIVIN DEL CAMPO, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Eleonor RIVIN DEL CAMPO, Dr
Facility:
Name:
Bordeaux - CHU
Address:
City:
Pessac
Country:
France
Contact:
Last name:
Claire BARDEL, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Claire BARDEL, Dr
Facility:
Name:
Lyon - HCL
Address:
City:
Pierre-benite
Country:
France
Contact:
Last name:
Sébastien COURAUD, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Sébastien COURAUD, Pr
Facility:
Name:
Rennes - CHU
Address:
City:
Rennes
Country:
France
Contact:
Last name:
Charles RICORDEL, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Charles RICORDEL, Dr
Facility:
Name:
Rouen - Centre Henri Becquerel
Address:
City:
Rouen
Country:
France
Contact:
Last name:
Sébastien THUREAU, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Sébastien THUREAU, Pr
Facility:
Name:
Nantes - CRLCC
Address:
City:
Saint-Herblain
Country:
France
Contact:
Last name:
Judith RAIMBOURG, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Judith RAIMBOURG, Dr
Facility:
Name:
Strasbourg - CRLCC
Address:
City:
Strasbourg
Country:
France
Contact:
Last name:
Delphine ANTONI, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Delphine ANTONI, Dr
Facility:
Name:
Toulouse - CHU
Address:
City:
Toulouse
Country:
France
Contact:
Last name:
Julien MAZIERES, Pr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Julien MAZIERES, Pr
Facility:
Name:
Tours - CHU
Address:
City:
Tours
Country:
France
Contact:
Last name:
Delphine CARMIER, Dr
Phone:
+331.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Delphine CARMIER, Dr
Facility:
Name:
Vandoeuvre-lès-Nancy - CRLCC
Address:
City:
Vandoeuvre-les-nancy
Country:
France
Contact:
Last name:
Jean-Christophe FAIVRE, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Jean-Christophe FAIVRE, Dr
Facility:
Name:
Metz - Hôpital Robert Schuman
Address:
City:
Vantoux
Country:
France
Contact:
Last name:
Benoît GODBERT, Dr
Phone:
+33 1.56.81.10.45
Email:
contact@ifct.fr
Contact backup:
Last name:
Benoît GODBERT, Dr
Start date:
January 2025
Completion date:
January 2032
Lead sponsor:
Agency:
Intergroupe Francophone de Cancerologie Thoracique
Agency class:
Other
Source:
Intergroupe Francophone de Cancerologie Thoracique
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06656598
