Durvalumab (immunotherapy) maintenance after thoracic chemoradiotherapy (CRT) in frail small cell lung cancer patients whose disease is limited to the thorax

Phase 1

Recruiting

• Conditions: Histologically confirmed frail Limited Disease Small Cell Lung Cancer (ECOG PS 2, ECOG PS 0-1 and older than 70 or did not receive a concomitant thoracic CRT because of comorbidities) previously untreated; MedDRA version: 21.1Level: PTClassification code: 10041069Term: Small cell lung cancer limited stage Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512224-11-00
• Lead Sponsor: nicancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-05
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

For Screening_Patient must have signed a first written informed consent form prior to screening visit and to any trial specific procedures, For Screening_Patient must be willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up, For Screening_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, For Screening_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., For Screening_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, For Screening_Patients affiliated to the social security system, For Screening_Histological confirmation of SCLC, For Screening_Measurable disease according to RECIST v1.1 criteria, For Screening_Patients must not have been previously treated for the SCLC. Note: patients who have already begun the initial CRT are eligible, For Screening_Patients =18 years old., For Randomization_Patient must have signed a second written informed consent form prior to randomization and to any specific trial procedure, For Randomization_Patients must belong to one of these groups at the screening visit after the thoracic CRT : ? ECOG PS 2. ? ECOG PS 0-1 and older than 70. ? ECOG PS 0-1 and who did not receive a concomitant thoracic CRT because of comorbidities (radiotherapy beginning before D1C3 of chemotherapy)._, For Randomization_Patients must have completed concomitant or sequential thoracic CRT by IMRT: ? Patients that received concomitant or sequential thoracic CRT must have received 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. All other schedules/methods performed need to be centrally approved before the randomization., For Randomization_Confirmation of disease control (SD, CR or PR) at radiological assessment with contrast enhanced thorax and upper abdomen CT-scan or PET-CT and contrast enhanced brain CT-scan or MRI after the thoracic CRT according to RECIST v1.1, For Randomization_Use of brain MRI in case of PCI avoidance is mandatory. PCI has to be prescribed according to the investigator’s choice and the local recommendations_, For Randomization_HRQoL questionnaire performed, For Randomization_Adequate haematological function ? Haemoglobin >9 g/dL. ? Platelet count >100 x 109L. ? Neutrophil count >1.5 x 109L., For Screening_Body weight >30 kg., For Randomization_Adequate renal function with a creatinine clearance =40 ml/min calculated with the Cockcroft-Gault formula._, For Randomization_Adequate hepatic function: ? Total bilirubin <1.5 Upper limit of normal (ULN). ? AST and ALT <2.5 ULN. ? Alkaline phosphatase <2.5 ULN., For Randomization_Any unresolved toxicity NCI CTCAE Grade =2 from previous anticanc

Exclusion Criteria

History of another primary malignancy except for a. 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. b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. c. Adequately treated carcinoma in situ without evidence of disease., Infection active connue, y compris une tuberculose (évaluation clinique qui inclut les antécédents cliniques, l'examen physique et les résultats radiographiques, ou test de TB conforme à la pratique locale) et une hépatite B et une hépatite C (test positif à l'anticorps du virus de l'hépatite C [VHC], à l'antigène de surface [HBsAg] du virus de l'hépatite B [VHB] ou à l'anticorps nucléocapsidique du VHB [anti-HBc]). Les patients présentant une infection à VHB passée ou résolue (définie par la présence de l'anticorps nucléocapsidique de l'hépatite B [anti-HBc] et l'absence de HBsAg) sont éligibles. Les patients positifs à l'anticorps de VHC sont éligibles uniquement si la réaction de polymérase en chaîne est négative pour l'ARN du VHC. Les patients connus pour être positifs au virus de l'immunodéficience humaine (VIH) (anticorps VIH 1/2 positifs) ne sont pas éligibles, Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients randomized in experimental arm should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of durvalumab., Patients with known or suspected hypersensitivity to durvalumab or any of its excipients, Patients who participated in another therapeutic trial within the 30 days prior to the start of the trial (screening phase included)., Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment., Female patients who are pregnant or breast feeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy, Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule., Persons deprived of their liberty or under protective custody or guardianship, 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: a. Patients with vitiligo or alopecia b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement c. Any chronic skin condition that does not require systemic therapy d. Patients without active disease in the last 5 years may be

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified