MEDI4736-2022

JRCT ID: jRCT2061220036

Registered date:22/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Recurrent small cell lung cancer
• Date of first enrollment: 11/10/2022
• Target sample size: 36
• Study type: Interventional
• Intervention(s): Intravenous infusion of Durvalumab 1,500 mg once every 3 weeks

Outcome(s)

• Primary Outcome: 1-year survival rate for combination therapy of durvalumab and amrubicin

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who have fully received an explanation and understood the purpose, contents, anticipated effects, and risks of the informed consent form and this study protocol, and who have given their free and voluntary written consent
2. 20 years of age or older at the time of enrollment in this clinical trial
3. ECOG PS of 0 or 1
4. Body weight of over 30kg
5. Patients with a histological or cytological diagnosis of small cell lung cancer. Combined small cell lung cancer will be included in this clinical trial, but LCNEC will not be included in this clinical trial.
6. Patients with extensive-stage small cell lung cancer who are refractory/intolerant to initial chemotherapy and who are undergoing second-line treatment
7. Patients who received at least one cycle of durvalumab or atezolizumab as initial chemotherapy
8. Patients with at least 1 lesion that qualifies as a RECIST 1.1 target lesion

Exclude criteria

1. Patients who have participated during the last 6 months or are currently participating in another clinical trial with an investigational product
2. Patients who have received the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) within 14 days prior to the first dose of the investigational drug
3. Patients with any unresolved toxicity NCI CTCAE Grade >=2 from previous anticancer therapy (excluding alopecia, vitiligo, and laboratory values defined in the inclusion criteria)
4. Patients receiving any concurrent chemotherapy, investigational drugs, biologic or hormonal therapy for cancer treatment
5. Patients who have received radiotherapy treatment (more than 30% of the bone marrow or with a wide field of radiation)within 28 days prior to the first dose of the investigational drug
6. Patients who have undergone major surgical procedure within 28 days prior to the first dose of the investigational drug
7. Patients with a history of allogeneic organ transplantation, hematopoietic stem cell transplantation, or other transplantation therapies
8. Patients with active autoimmune disease, poorly controlled endocrine disease, inflammatory disease, or a confirmed medical history of such disease
9. Patients with uncontrolled intercurrent 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
10. Patients with a medical history of another primary malignancy

Related Information

• Primary Sponsor: Kato Yuka
• Source(s) of Monetary Support: AstraZeneca K.K.