Small Cell Lung Cancer (SCLC) Clinical Trials

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A Multicenter Randomized Open Label Phase II Study Evaluating the Efficacy and the Tolerance of Immunochemotherapy and of Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Unresectable Stage III Non Small Cell Lung Cancer

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

⁃ 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.

Locations
Other Locations
France
Angers - Centre Paul Papin
RECRUITING
Angers
Angers - CHU
RECRUITING
Angers
Avignon - CH
RECRUITING
Avignon
Boulogne - Ambroise Paré
RECRUITING
Boulogne
Brest - CHU
RECRUITING
Brest
Caen - CHU
RECRUITING
Caen
Caen - CRLCC
RECRUITING
Caen
Créteil - CHI
RECRUITING
Créteil
Dijon - CRLCC
RECRUITING
Dijon
Le Mans - CHG
RECRUITING
Le Mans
Lille - CRLCC
RECRUITING
Lille
Marseille - APHM
RECRUITING
Marseille
Mulhouse - GHRMSA
RECRUITING
Mulhouse
Paris - Bichat
RECRUITING
Paris
Paris - Hôpital Cochin
RECRUITING
Paris
Paris - Tenon
RECRUITING
Paris
Bordeaux - CHU
RECRUITING
Pessac
Lyon - HCL
RECRUITING
Pierre-bénite
Rennes - CHU
RECRUITING
Rennes
Rouen - Centre Henri Becquerel
RECRUITING
Rouen
Nantes - CRLCC
RECRUITING
Saint-herblain
Strasbourg - CRLCC
RECRUITING
Strasbourg
Toulouse - CHU
RECRUITING
Toulouse
Tours - CHU
RECRUITING
Tours
Vandoeuvre-lès-Nancy - CRLCC
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Contact IFCT
contact@ifct.fr
+33 1.56.81.10.45
Time Frame
Start Date: 2025-11-07
Estimated Completion Date: 2032-01
Participants
Target number of participants: 152
Treatments
Active_comparator: 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.
Experimental: 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.
Sponsors
Leads: Intergroupe Francophone de Cancerologie Thoracique

This content was sourced from clinicaltrials.gov