What is durvalumab studying for large-cell neuroendocrine carcinoma of the lung?

Durvalumab is being studied in combination with etoposide and platinum chemotherapy to evaluate its effectiveness as a first-line treatment for advanced large-cell neuroendocrine carcinoma of the lung. The research aims to improve progression-free survival at 12 months for patients with this aggressive lung cancer. The study is sponsored by Centre Leon Berard and conducted at multiple centers.

Who may be eligible for this large-cell neuroendocrine carcinoma clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of advanced large-cell neuroendocrine carcinoma of the lung may be eligible. Participants must have good performance status, adequate organ function, and not be pregnant or breastfeeding. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this large-cell neuroendocrine carcinoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not always covered. Participants should plan accordingly for any transportation or accommodation costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06393816

A Multicenter Phase II Study Evaluating the Efficacy and Safety of Durvalumab Combined With Etoposide and Platinum as First-Line Treatment in Patients With Large-cell Neuroendocrine Carcinoma of the Lung

Led by Centre Leon Berard · Updated on 2024-08-02

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Large-cell neuroendocrine carcinomas LCNECs of the lung are rare, aggressive tumors with poor prognosis and limited treatment options. Researchers are evaluating the combination of durvalumab with etoposide and platinum chemotherapy as a first-line treatment to improve the progression-free rate at 12 months in patients with advanced LCNEC confirmed by expert pathologist review. This phase II, multicenter, open-label study aims to assess the efficacy and safety of this combination compared to historical data. Participants will receive durvalumab combined with etoposide and either cisplatin or carboplatin. Treatment includes an induction phase with cycles every three weeks for 12 weeks four cycles, followed by a maintenance phase with durvalumab every four weeks for up to 24 months. This prospective study uses an external control arm for comparison and focuses on first-line treatment of advanced LCNEC. During the study, patients will be closely monitored through scheduled visits and assessments, including radiological evaluations to measure disease progression. Researchers will track the progression-free rate at 12 months as the primary outcome and also evaluate objective response rates, disease control rates, overall survival, and safety profiles over a period of up to 63 months. Participants will be followed for adverse events and treatment-emergent effects for up to 27 months and 90 days post-treatment, ensuring comprehensive safety and efficacy evaluation.

CONDITIONS

Brief Title

FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at study entry
Histological diagnosis of Large-Cell Neuroendocrine Carcinoma of the lung
Sufficient tumor material available for central confirmation and analyses
Locally advanced (Stage III) or metastatic (Stage IV) disease eligible for first-line treatment
Patients with recurrence beyond 3 months after last chemotherapy are eligible
Measurable disease according to RECIST 1.1 criteria
Eastern Cooperative Oncology Group performance status of 0 or 1
Body weight greater than 30 kilograms
Life expectancy of at least 12 weeks
Adequate organ and marrow function per specified laboratory values
Female patients must be post-menopausal or have negative pregnancy tests
Use of highly effective contraception during treatment and specified post-treatment periods
Willingness and ability to comply with study procedures and visits
Affiliation to a social security system
Ability to provide signed informed consent

You will not qualify if you...

Concurrent enrollment in another interventional clinical study, except observational or during follow-up period
Previous treatment for metastatic LCNEC
Prior use of PD1 or PD-L1 inhibitors including durvalumab
Use of concurrent chemotherapy, investigational products, biologics, or hormonal cancer therapies
Major surgery within 21 days prior to first study drug dose
History of allogenic organ transplantation
Active or prior autoimmune or inflammatory disorders, except specified exceptions
Uncontrolled illnesses such as infections, heart failure, unstable angina, or psychiatric conditions limiting compliance
History of other primary malignancies unless meeting specific remission criteria
Central nervous system metastases unless stable and asymptomatic
Carcinomatous meningitis
QTcF interval greater than 470 ms
History of active primary immunodeficiency
Active hepatitis B or C infections, HIV positive, or active tuberculosis
Recent use of immunosuppressive medication except specified exceptions
Receipt of live attenuated vaccine within 30 days prior to first dose
Known allergy or hypersensitivity to study drugs or excipients
Pregnancy or breastfeeding woman

Research Team

Julien GAUTIER

Luc ODIER, MD

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