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New treatment option for Large Cell Neuroendocrine Carcinoma of the Lung
Official title FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum
ClinicalTrials.gov ID: NCT06393816
What this study is testing
What is Durvalumab with etoposide and Carboplatin/Cisplatin?
Durvalumab with etoposide and Carboplatin/Cisplatin is an investigational medicine, being studied as a potential treatment for large cell neuroendocrine carcinoma of the lung.
Also referred to as MEDI4736.
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 primary objective is to determine the efficacy (Progression-Free Rate at 12 months) of durvalumab combined with etoposide and platinum (either cisplatin or carboplatin) for the first-line treatment of patients with advanced LCNEC confirmed by centralized expert-pathologist review
- 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
- Age ≥ 18 years at the time of study entry;
- Locally documented histological diagnosis of Large-Cell NeuroEndocrine Carcinoma of the lung (2021 WHO classification of Lung Tumors );
- Patient must have sufficient material to achieve central histological confirmation and exploratory analyses (1 representative FFPE block or at least...
- Setting of the disease: locally advanced (Stage III) not eligible for loco-regional therapy or metastatic (Stage IV) in first line treatment (8th TNM...
- Measurable disease as per the RECIST 1.1;
You likely can't join if
- Concurrent enrolment in another clinical study, unless it is an observational (non-treatment) clinical study or during the follow-up period of an...
- Patient previously treated for a LCNEC in a metastatic setting;
- Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab;
- Any concurrent chemotherapy, Investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for...
- Major surgical procedure (as defined by the Investigator) within 21 days prior to the first dose of study drugs; Note: Local surgery or radiotherapy...
- History of allogenic organ transplantation;
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of study entry;
- Locally documented histological diagnosis of Large-Cell NeuroEndocrine Carcinoma of the lung (2021 WHO classification of Lung Tumors );
- Patient must have sufficient material to achieve central histological confirmation and exploratory analyses (1 representative FFPE block or at least 10 unstained slides);
- Setting of the disease: locally advanced (Stage III) not eligible for loco-regional therapy or metastatic (Stage IV) in first line treatment (8th TNM classification). Nota Bene: patients with recurrence of local or...
- Measurable disease as per the RECIST 1.1;
- Performance Status (PS) of the Eastern Cooperative Oncology Group (ECOG): 0 or 1 ;
- Body weight \> 30Kg;
- Must have a life expectancy of at least 12 weeks;
- Adequate normal organ and marrow function as defined below:
- Haemoglobin ≥8.0 g/dL (with or without transfusion)
- Absolute neutrophil count (ANC) ≥1.5 × 109 /L
- Platelet count ≥100 × 109/L
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)), or ≤3.0xULN in case of liver metastases. Note: this will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent...
- AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
- For patients undergoing a treatment by cisplatin: measured creatinine clearance (CrCl) ≥60 mL/min or Calculated creatinine CrCl ≥60 mL/min by the CKD-EPI equation or by 24-hour urine collection for determination of...
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an...
- Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and...
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation induced menopause with last menses...
- Patient (male or female) using a highly effective contraception as defined in during the treatment period and at least up to 6 months after the last administration of chemotherapy or 90 days after the last...
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Affiliation to a social security system;
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent obtained from the...
What rules you out
- Concurrent enrolment in another clinical study, unless it is an observational (non-treatment) clinical study or during the follow-up period of an treatment study (wash-out period of 28 days);
- Patient previously treated for a LCNEC in a metastatic setting;
- Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab;
- Any concurrent chemotherapy, Investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is...
- Major surgical procedure (as defined by the Investigator) within 21 days prior to the first dose of study drugs; Note: Local surgery or radiotherapy of isolated lesions for palliative intent is acceptable.
- History of allogenic organ transplantation;
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus...
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia...
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease, or Gleason ≤6 prostate cancer.
- Central Nervous System metastases, unless asymptomatic (including patients treated with anticonvulsants) or previously treated (surgery or radiation therapy combined with corticosteroids ≤10 mg per day) and stable at...
- Carcinomatous meningitis;
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms;
- History of active primary immunodeficiency;
- Active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection...
- Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection;
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed "10 mg/day" of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of...
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients;
- Pregnant or breast-feeding woman
The study team makes the final eligibility decision.
Where it's taking place
- Aix-en-Provence, France
- Amiens, France
- Angers, France
- Avignon, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Créteil, France
- Épagny, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lorient, France
- Lyon, France
- Marseille, France
- Meaux, France
- Mulhouse, France
- Nice, France
- Paris, France
- Pessac, France
+ 9 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 Aix-en-Provence, France; Amiens, France; Angers, France; Avignon, France; Brest, France; Caen, France and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.