Adjuvant Chemotherapy +/- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer
NCT ID: NCT06656598
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
152 participants
INTERVENTIONAL
2025-04-30
2032-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (neoadjuvant chemotherapy only)
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.
Carboplatin
Neoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks).
Paclitaxel
Neoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks).
Curative hypofractionated radiotherapy
Curative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant treatment.
Cemiplimab (maintenance)
Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of radiotherapy (12 months).
Arm B (neoadjuvant chemo-immunotherapy)
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.
Carboplatin
Neoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks).
Paclitaxel
Neoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks).
Cemiplimab
Neoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks).
Curative hypofractionated radiotherapy
Curative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant treatment.
Cemiplimab (maintenance)
Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of radiotherapy (12 months).
Interventions
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Carboplatin
Neoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks).
Paclitaxel
Neoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks).
Cemiplimab
Neoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks).
Curative hypofractionated radiotherapy
Curative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant treatment.
Cemiplimab (maintenance)
Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of radiotherapy (12 months).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Intergroupe Francophone de Cancerologie Thoracique
OTHER
Responsible Party
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Locations
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Angers - Centre Paul Papin
Angers, , France
Angers - CHU
Angers, , France
Avignon - CH
Avignon, , France
Boulogne - Ambroise Paré
Boulogne, , France
Brest - CHU
Brest, , France
Caen - CHU
Caen, , France
Caen - CRLCC
Caen, , France
Créteil - CHI
Créteil, , France
Dijon - CRLCC
Dijon, , France
Le Mans - CHG
Le Mans, , France
Lille - CRLCC
Lille, , France
Marseille - APHM
Marseille, , France
Mulhouse - GHRMSA
Mulhouse, , France
Paris - Bichat
Paris, , France
Paris - Hôpital Cochin
Paris, , France
Paris - Tenon
Paris, , France
Bordeaux - CHU
Pessac, , France
Lyon - HCL
Pierre-Bénite, , France
Rennes - CHU
Rennes, , France
Rouen - Centre Henri Becquerel
Rouen, , France
Nantes - CRLCC
Saint-Herblain, , France
Strasbourg - CRLCC
Strasbourg, , France
Toulouse - CHU
Toulouse, , France
Tours - CHU
Tours, , France
Vandoeuvre-lès-Nancy - CRLCC
Vandœuvre-lès-Nancy, , France
Metz - Hôpital Robert Schuman
Vantoux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IFCT-2401
Identifier Type: -
Identifier Source: org_study_id
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