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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Neoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks).
Neoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks).
Neoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks).
Angers - Centre Paul Papin
Angers, France
RECRUITINGProgression-Free Survival (PFS)
Time from randomization to progression or death.
Time frame: About 18 months
Objective Response Rate (ORR)
Proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR)
Time frame: 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)
Time frame: About 18 months
PFS at 12 months
Time from randomization to progression or death.
Time frame: At 12 months
PFS at 18 months
Time from randomization to progression or death.
Time frame: At 18 months
PFS at 3 year
Time from randomization to progression or death.
Time frame: At 3 year
Overall Survival (OS) curve
Time from date of inclusion to the date of death due to any cause.
Time frame: About 3 year
OS at 12 months
Time from date of inclusion to the date of death due to any cause.
Time frame: At 12 months
OS at 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Curative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant treatment.
Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of radiotherapy (12 months).
Angers - CHU
Angers, France
RECRUITINGAvignon - CH
Avignon, France
RECRUITINGBoulogne - Ambroise Paré
Boulogne, France
RECRUITINGBrest - CHU
Brest, France
RECRUITINGCaen - CHU
Caen, France
RECRUITINGCaen - CRLCC
Caen, France
RECRUITINGCréteil - CHI
Créteil, France
RECRUITINGDijon - CRLCC
Dijon, France
RECRUITINGLe Mans - CHG
Le Mans, France
RECRUITING...and 15 more locations
Time from date of inclusion to the date of death due to any cause.
Time frame: At 18 months
OS at 3 year
Time from date of inclusion to the date of death due to any cause.
Time frame: 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.
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 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
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 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
Time frame: About 18 months