Actively Recruiting
Adjuvant Chemotherapy +/- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer
Led by Intergroupe Francophone de Cancerologie Thoracique · Updated on 2026-02-11
152
Participants Needed
25
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Adjuvant Chemotherapy +/- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures.
- Willing and able to follow scheduled visits, treatment, and tests.
- Age 18 years or older.
- Histologically or cytologically confirmed unresectable Stage IIIA, IIIB, or IIIC NSCLC.
- For patients over 70 years: ECOG Performance Status 0 to 1.
- For patients under 70 years: ECOG Performance Status 0 to 1 with Charlson comorbidity score 3 or ECOG PS 2.
- Eligible for sequential radio-chemotherapy as approved by a multidisciplinary committee.
- Measurable disease per RECIST 1.1 criteria.
- Respiratory function: FEV1 3 40% of theoretical value, DLCO 3 40%.
- Bone marrow function: ANC 3 1.5 x 10^9/L, platelets 3 100 x 10^9/L, hemoglobin 3 9 g/dl.
- Renal and hepatic function: creatinine clearance 3 45 ml/min, bilirubin 1.5x upper limit normal (ULN), AST and ALT 3 3x ULN, albumin 3 28 g/dl.
- Has national health insurance coverage.
- Effective contraception during treatment and for 6 months after last dose for patients of childbearing potential and sexually active males.
You will not qualify if you...
- Contraindication to immunotherapy or chemotherapy.
- Eligible for concomitant radio-chemotherapy.
- Stage I or II NSCLC.
- Prior treatment with anti-PD1/PDL1, anti-CTLA, or other immunotherapy or chemotherapy for NSCLC.
- Histology other than primary NSCLC.
- Presence of activating EGFR mutation, ALK, or ROS1 translocation.
- Metastatic NSCLC including brain metastases.
- Not eligible for curative radiotherapy due to tumor extension or dose constraints.
- Severe uncontrolled comorbidities or intercurrent diseases (e.g., recent acute coronary syndrome, heart failure with LVEF 30%, uncontrolled hypertension, severe sepsis).
- Weight loss 3 15% in last 6 months.
- ECOG Performance Status greater than 2.
- Active autoimmune diseases except certain thyroid or type 1 diabetes under treatment.
- History of idiopathic pulmonary fibrosis or active interstitial lung disease.
- Recent immunosuppressive therapy or corticosteroids above specified doses.
- Chronic active infections including tuberculosis, HIV, hepatitis B or C unless cured.
- Severe infections within 4 weeks prior to study treatment.
- Recent history of other cancers within 3 years except specific skin or uterine cancers.
- Previous thoracic radiotherapy.
- Live attenuated vaccine within 28 days before chemotherapy.
- History of organ or bone marrow transplantation.
- Major surgery within 4 weeks before treatment.
- Participation in another therapeutic trial.
- Pregnant or breastfeeding women.
- Adults under guardianship or curatorship.
- Inability to undergo medical monitoring due to social, geographical, or physical reasons.
- Inability to understand the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Angers - Centre Paul Papin
Angers, France
Actively Recruiting
2
Angers - CHU
Angers, France
Actively Recruiting
3
Avignon - CH
Avignon, France
Actively Recruiting
4
Boulogne - Ambroise Paré
Boulogne, France
Actively Recruiting
5
Brest - CHU
Brest, France
Actively Recruiting
6
Caen - CHU
Caen, France
Actively Recruiting
7
Caen - CRLCC
Caen, France
Actively Recruiting
8
Créteil - CHI
Créteil, France
Actively Recruiting
9
Dijon - CRLCC
Dijon, France
Actively Recruiting
10
Le Mans - CHG
Le Mans, France
Actively Recruiting
11
Lille - CRLCC
Lille, France
Actively Recruiting
12
Marseille - APHM
Marseille, France
Actively Recruiting
13
Mulhouse - GHRMSA
Mulhouse, France
Actively Recruiting
14
Paris - Bichat
Paris, France
Actively Recruiting
15
Paris - Hôpital Cochin
Paris, France
Actively Recruiting
16
Paris - Tenon
Paris, France
Actively Recruiting
17
Bordeaux - CHU
Pessac, France
Actively Recruiting
18
Lyon - HCL
Pierre-Bénite, France
Actively Recruiting
19
Rennes - CHU
Rennes, France
Actively Recruiting
20
Rouen - Centre Henri Becquerel
Rouen, France
Actively Recruiting
21
Nantes - CRLCC
Saint-Herblain, France
Actively Recruiting
22
Strasbourg - CRLCC
Strasbourg, France
Actively Recruiting
23
Toulouse - CHU
Toulouse, France
Actively Recruiting
24
Tours - CHU
Tours, France
Actively Recruiting
25
Vandoeuvre-lès-Nancy - CRLCC
Vandœuvre-lès-Nancy, France
Actively Recruiting
Research Team
C
Contact IFCT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here