BridgeMD
New treatment option for Stage III NSCLC
Official title Adjuvant Chemotherapy +/- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer
ClinicalTrials.gov ID: NCT06656598
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, being studied as a potential treatment for stage iii nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines...
- 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...
- 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...
You likely can't join if
- Immunotherapy or chemotherapy contra-indicated.
- Patients eligible for treatment with concomitant radio-chemotherapy validated by multidisciplinary committee.
- Stage I or II NSCLC.
- Previously received a treatment with anti-PD1/PDL1, anti-CTLA, or other antineoplastic immunotherapy or chemotherapy for NSCLC.
- Histology other than primary non-small cell lung cancer.
- Patients with an activating EGFR mutation or ALK or ROS1 translocation.
See the full eligibility criteria
- 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...
- 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...
- 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 people who are sexually active with a woman of childbearing...
- Immunotherapy or chemotherapy contra-indicated.
- Patients eligible for treatment with concomitant radio-chemotherapy validated by multidisciplinary committee.
- Stage I or II NSCLC.
- Previously received a treatment with anti-PD1/PDL1, anti-CTLA, or other antineoplastic immunotherapy or chemotherapy for NSCLC.
- Histology other than primary non-small cell lung cancer.
- Patients with an activating EGFR mutation or ALK or ROS1 translocation.
- Metastatic NSCLC including brain metastasis.
- Patients not eligible for curative radiotherapy (tumor extension, predictable dose constraints that cannot be met).
- 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...
- Weight loss ≥15% of total body weight in the last 6 months.
- ECOG PS upper 2
- Active autoimmune pathology. History of autoimmune pathology including myasthenia, Guillain-Barre syndrome, lupus erythematosus, antiphospholipid syndrome, Wegener's granulomatosis, glomerulonephritis, inflammatory...
- History of idiopathic pulmonary fibrosis, organized pneumopathy or signs of active interstitial pulmonary pathology on CT scan.
- 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...
- 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...
- 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.
- 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).
- History of thoracic radiotherapy.
- Live attenuated vaccine received within 28 days of starting chemotherapy
- History of organ or bone marrow transplantation.
- Major surgery within 4 weeks of starting treatment.
- Patient already included in another therapeutic trial.
- Positive pregnancy test or breastfeeding woman.
- Protected adults (under guardianship or curatorship).
- Inability to undergo medical monitoring of the study (for geographical, social and/or physical reasons).
- Patients unable to understand the study.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Avignon, France
- Boulogne, France
- Brest, France
- Caen, France
- Créteil, France
- Dijon, France
- Le Mans, France
- Lille, France
- Marseille, France
- Mulhouse, France
- Paris, France
- Pessac, France
- Pierre-Bénite, France
- Rennes, France
- Rouen, France
- Saint-Herblain, France
- Strasbourg, France
- Toulouse, France
- Tours, France
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Avignon, France; Boulogne, France; Brest, France; Caen, France; Créteil, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.