A phase 2 study of chemotherapy and durvalumab with TRT in patients with ED-SCLC

JRCT ID: jRCTs071200101

Registered date:24/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: extensive disease small cell lung cancer(ED-SCLC)
• Date of first enrollment: 23/03/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Randomly assign to two treatment groups.
In the safety comparison phase, 10 patients in the concurrent and sequential groups
will be compared.
After interruption of enrollment and safety evaluation at the time of enrollment of 20 patients, the enrollment of the remaining 40 patients will be resumed in any group considered to be able to continue the study.
Concurrent group: Platinum + etoposide + durvalumab + radiotherapy, followed by durvalumab maintenance
Sequential group: platinum + etoposide +durvalumab, followed by radiotherapy + durvalumab maintenance

Outcome(s)

• Primary Outcome: Incidence of >= Grade2 pneumonitis within 6 months from the start of radiation therapy

Secondary Outcome

Median overall survival
Median progression-free survival based on RECIST 1.1
Overall response rate
Safety (all adverse events , all grades of pneumonitis , electrocardiograms , and laboratory findings including clinical chemistry test and blood test).

Key inclusion & exclusion criteria

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

Include criteria

1)Patients providing the written informed consent.
2)Patient with at least 20 years of age (at enrolment date).
3)ECOG performance status of 0 or 1
4)Patients with small cell lung cancer confirmed histologically or cytologically,and diagnosed as "extensive-disease" depending on the degree of progression.
5)Patients without symptomatic brain metastases. For patients with brain metastases, use of steroids and anticonvulsants for at least 1 month prior to enrolment should be stable.
6)Patients with no prior treatment history for extensive-disease small cell lung cancer.
7)Patients with at least one measurable lesion as defined in RECIST criteria version 1.1.
8) Patients with lung lesions suitable for irradiation.
9) Body weight >30 kg
10) Patients with life expectancy of at least 12 weeks at the time of enrolment.
11)The functions of major organs such as bone marrow, liver, and kidney are maintained and the following criteria are met within 2 weeks before enrolment (test on the same day of the week 2 weeks before enrolment is eligible)
Hemoglobin >= 9.0 g/dL
Absolute neutrophil count (ANC) >= 1.5 x 10^3 / microL
Platelet count >= 100 x 10^3 / microL
Serum bilirubin <=1.5 x institutional upper limit of normal (ULN).(however, <= 3 x ULN with Gilbert's syndrome)
AST (SGOT)/ALT (SGPT) <= 2.5 x ULN (however,<=5 x ULN with liver metastases)
12) In the case of women, patients who can be confirmed to be postmenopausal.
Moreover, in the case of premenopausal women, effective contraceptive methods are being implemented and pregnancy is negative or 28 days or more after childbirth and
not breastfeeding.

Exclude criteria

1) Patients with known allergies, hypersensitivity, or medical contraindications to durvalumab, platinum (carboplatin or cisplatin), etoposide, or their pharmaceutical additives.
2) Patients receiving combination chemotherapy, investigational new drugs, biologics, or hormone therapy for the treatment of cancer.
3) Patients with a medical history of thoracic radiation therapy.
4) Patients with major surgery within 28 days prior to enrolment.
5) Patients with a medical history of allogeneic organ transplantation.
6) Patients requiring systemic treatment (systemic steroids or immunosuppressants) for autoimmune paraneoplastic syndrome (PNS), or patients with clinical symptoms suggesting worsening of PNS.
7) Patients with autoimmune disease or inflammatory disease, diverticulitis, systemic lupus erythematosus, sarcoidosis syndrome or Wegener's syndrome confirmed now or in the past.
8) Patients with infectious diseases requiring systemic treatment (administration of antibacterial drugs and antifungal drugs)
9) Patients with psychosis or psychiatric symptoms that may interfere with the
implementation of protocol treatment, and that the investigator judges as difficult to participate in the study.
10) Patients with clinically significant complications.
Serious or uncontrollable systemic disease (active infections including uncontrollable hypertension, heart disease, severe arrhythmias requiring medication, persistent watery diarrhoea, active bleeding)
11) Patients with obvious active interstitial lung disease.
12) Patients with uncontrollable diabetes mellitus.
13) Patients with active double cancer (simultaneous double cancer and metachronous double cancer with a disease-free period of 5 years or less).
14) Patients with anamnesis of meningeal dissemination.
15) Patients with anamnesis of active primary immunodeficiency.
16) Patients with active infections such as tuberculosis and hepatitis B.
17) Patients with a history of immunosuppressive drug use at present or within 14 days before enrolment.
18) Patients with administration of live attenuated vaccine within 30 days before enrolment.
19) Pregnant or lactating women, or fertile men or women who are unwilling to adopt effective contraception from screening to 90 days after the final dose of durvalumab.
20) Any other patients who are regarded as unsuitable for this study by the investigators.

Related Information

• Primary Sponsor: Takayama Koichi
• Source(s) of Monetary Support: AstraZeneca K.K.