Durvalumab Maintenance After Thoracic Chemoradiotherapy in Frail Small Cell Lung Cancer Patients Whose Disease is Limited to the Thorax

NCT05617963 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: UC-IMM-2106
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 32

Brief Summary

This study is an academic-lead, open-label, multicenter, randomized phase II trial for frail limited disease Small Cell Lung Cancer (LD-SCLC) patients. Frail conditions are: Eastern Cooperative Oncology Group performance status (ECOG PS) 2 or ECOG PS 0-1 and older than 70 or ECOG PS 0-1 and did not receive a concomitant thoracic chemo-radiotherapy (CRT) because of comorbidities. During the screening phase, patients complete either the standard concomitant or sequential thoracic CRT and cisplatin-etoposide regimen or carboplatin AUC5 to AUC6 etoposide regimen. Patients showing a disease control (defined as stable disease \[SD\], partial response \[PR\], or complete response \[CR\] according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT can receive prophylactic cranial irradiation (PCI) as per local practice. They will then be treated by durvalumab every 4 weeks. DURVALUNG study aims to evaluate the activity of durvalumab maintenance treatment in frail LD-SCLC patients who have not progressed following platinum-based concomitant or sequential CRT.

Conditions

Small Cell Lung Carcinoma

Keywords

immunotherapy; maintenance treatment

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

  From inclusion to disease progression or death, up to 3.5 years

Secondary Outcomes (4)

• Overall survival

  From inclusion to death, up to 3.5 years

• Occurrence of adverse events coded using NCI CTC-AE version 5.0.(Safety )

  Throughout study completion, up to 4 years

• Quality of life questionnaire - Core 30 (QLQ-C30)

  At inclusion before treatment start and every 4 weeks for the first year from inclusion and then every 12 weeks until end of treatment or death, up to 2 years

• Quality of life questionnaire - Lung cancer module (QLQ-LC13)

  At inclusion before treatment start and every 4 weeks for the first year from randomization and then every 12 weeks until end of treatment or death, up to 2 years

Study Arms (1)

Durvalumab maintenance

OTHER

Patients will receive durvalumab intravenously 1500 mg every 4 weeks until disease progression, unacceptable toxicity, death or patient's decision for a maximum of 24 months. For patients receiving prophylactic cranial irradiation as per standard of care, the first dose of durvalumab may be delayed by up to 42 days from the end of the CRT. Radiological assessments will be planned every 12 weeks (± 7 days) of maintenance treatment. The first dose of durvalumab should be administered within 3 days of inclusion.

Drug: Durvalumab

Interventions

Durvalumab DRUG

Patients showing a disease control (defined as stable disease \[SD\], partial response \[PR\], or complete response \[CR\] according to RECIST v1.1) at the radiological evaluation performed after the end of thoracic CRT will receive durvalumab intravenously 1500 mg every 4 weeks until disease progression, unacceptable toxicity, death or patient's decision for a maximum of 24 months.

Durvalumab maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria for Screening
• Patient must have signed a first written informed consent form prior to screening visit and to any trial specific procedures.
• Histological confirmation of SCLC.
• Limited disease (T0-T4, N0-N3 and M0) according to the TNM classification 8th edition or to the VALSG 2-stage classification. As per standard guidelines a complete radiological evaluation has to be performed within 28 days before the start of induction chemotherapy including all the radiological exams below:
• Total body PET- scan.
• Contrast enhanced CT-scan of thorax and upper abdomen.
• Contrast enhanced MRI or CT-scan of brain.
• Measurable disease according to RECIST v1.1 criteria.
• Patients must not have been previously treated for the SCLC. Note: patients who have already begun the initial CRT are eligible.
• Patients ≥18 years old.
• Body weight \>30 kg.
• Patients can be candidate to concomitant or sequential thoracic CRT by IMRT. Patients have to receive at least 60 Gy (one-daily fraction of 1.8-2 Gy) or 45 Gy twice daily (1.5 Gy per fraction) combined with cisplatin-etoposide regimen or with carboplatin AUC5 to AUC6 etoposide regimen.
• Patients that received previous thorax radiotherapy may be eligible if they can receive the CRT schedule planned in the clinical study according to previous irradiation fields and, in any case, after the medical monitor agreement.
• Women of childbearing potential must have a negative serum beta-HCG test before the beginning of the trial, during the study treatment and for a period of at least 3 months after the last administration of the experimental drug.
• All sexually active men and women of childbearing potential must use an effective contraception method for the duration of study treatment and for 3 months after completing treatment.

You may not qualify if:

• 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 durvalumab 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.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
• 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 erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• 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.
• Any concurrent chemotherapy, immune checkpoint inhibitors, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
• History of leptomeningeal carcinomatosis.
• Major surgical procedure (as defined by the Investigator) including surgical resection of the primary disease, within 28 days prior to the first dose of IMP.
• History of allogenic organ transplantation.

Sponsors & Collaborators

• UNICANCER: lead
• AstraZeneca: collaborator

Study Sites (32)

Centre de Radiothérapie du Pays d'Aix

Aix-en-Provence, France

Location

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Location

Institut du Cancer Avignon-Provence

Avignon, France

Location

Centre d'Oncologie du Pays Basque

Bayonne, France

Location

CH de la côte Basque

Bayonne, France

Location

Clinique Belharra

Bayonne, France

Location

Centre François Baclesse

Caen, France

Location

CHU de CAEN

Caen, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

CHI Créteil

Créteil, France

Location

Centre George François Leclerc

Dijon, France

Location

Centre Oscar Lambret

Lille, France

Location

CHU Dupuytren

Limoges, France

Location

Polyclinique de Limoges -Site Clinique Chénieux

Limoges, France

Location

Groupe Hospitalier Bretagne Sud

Lorient, France

Location

Centre Léon Bérard

Lyon, France

Location

APHM - Hôpital Nord

Marseille, France

Location

Hopital européen Marseille

Marseille, France

Location

Hopital privé Clairval

Marseille, France

Location

Institut Paoli-Calmettes

Marseille, France

Location

Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

Montpellier, France

Location

Hopital privé du Confluent

Nantes, France

Location

Centre Lacassagne

Nice, France

Location

Hôpital Tenon APHP

Paris, France

Location

Institut Curie

Paris, France

Location

CARIO

Plérin, France

Location

Institut Godinot

Reims, France

Location

Centre Henri Becquerel

Rouen, France

Location

CH Saint Brieuc

Saint-Brieuc, France

Location

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, France

Location

Centre d'oncologie Saint Yves

Vannes, France

Location

Hopital Nord Ouest - Villefranche sur Saône

Villefranche-sur-Saône, France

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Elisa GOBBINI, MD

  Institut Curie Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients showing a disease control after the end of thoracic CRT will receive durvalumab intravenously 1500 mg every 4 weeks until disease progression, unacceptable toxicity, death, patient's decision, or for a maximum of 24 months (26 doses/cycles).

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: March 24, 2023
• Primary Completion (Estimated): February 24, 2028
• Study Completion (Estimated): February 24, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
• Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.

Locations

FR (32)