REBORN study

JRCT ID: jRCT2051200125

Registered date:29/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Small cell lung cancer
• Date of first enrollment: 07/05/2021
• Target sample size: 41
• Study type: Interventional

Intervention(s)

As induction therapy, patients will receive durvalumab 1500 mg, irinotecan (60 mg/m2), and cisplatin (60 mg/m2) on day 1 and irinotecan (60 mg/m2) on days 8 and 15. This constitutes one cycle. This treatment will be given every 4 weeks (every 28 days) for up to 4 cycles. Then, patients will continue to receive durvalumab 1500 mg every 4 weeks (every 28 days) as maintenance therapy until the protocol treatment discontinuation criteria are met.
No maximum duration of study treatment will be set. If there is any patient who can be treated beyond the study period and wishes to continue treatment, it will be determined by discussion.

Outcome(s)

• Primary Outcome: Proportion of 12-month progression-free survival (central imaging review)

Secondary Outcome

Progression-free survival (central imaging review and assessment by the treating physician)
Proportion of progression-free survival (6 months, 18 months, 24 months)
Overall survival
Proportion of overall survival (12 months, 18 months, 24 months)
Response rate (assessed by the treating physician)
Disease control rate (assessed by the treating physician)
Duration of response (assessed by the treating physician)
Safety
UGT1A1 and adverse events and efficacy assessment
Subgroup analysis by patient background

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 74age old
• Gender: Both

Include criteria

1)Patients 20 to 74 years of age at the time of informed consent
2)The patient has provided written informed consent after the study has been fully explained and is willing to comply with the protocol.
3)Patients with pathological diagnosis by histology or cytology that is consistent with small cell lung cancer
4)Extensive stage*
*For the definition of extensive stage, see 4.2 Definition of extensive-stage small cell lung cancer to be used in this study.
5)Patients with measurable lesions according to response evaluation criteria in solid tumors (RECIST) version 1.1.
6)Untreated brain metastases without symptoms and the following brain metastases are eligible.
However, patients with meningeal carcinomatosis are excluded.
7)Chemotherapy-naive patients
8)Patients without a history of chest irradiation
However, palliative radiation to sites other than the chest is permitted (e.g., bone metastasis).
9)ECOG performance status (PS) 0-1
10)Patients who have no severe disorder in major organs (e.g., bone marrow, heart, lung, liver, kidney) and meet the following criteria: (The most recent data obtained within 14 days from the date of enrollment will be used for enrollment. The same day of the week 2 weeks before the enrollment is acceptable.)
11)Body weight >30 kg
12)Expected to be alive at least 12 weeks from the start of treatment.
13)For women, evidence of post-menopausal status or negative urine or serum pregnancy test.

Exclude criteria

1) Patients with active multiple cancer
2) Patients with active systemic infection.
3) Patients with obvious active hepatitis B or C virus infection (even if HBs antibody is positive, the patient is eligible if the viral load is below the sensitivity and the patient does not have active hepatitis. Patients positive for HCV antibody are eligible if they have no active hepatitis. However, HBV-DNA and HCV- RNA must be appropriately monitored.)
4) Interstitial lung disease is evident on CT.
5) Patients with active autoimmune disease or a history of autoimmune disease requiring steroid therapy or immunosuppressants
6) Patients who need continued systemic (oral or intravenous) administration of steroids equivalent to prednisolone >10 mg/day, or who used immunosuppressants within 14 days before enrollment for indications other than autoimmune disease
7) Patients with symptomatic congestive heart failure, unstable angina, or myocardial infarction within 6 months before enrollment
8) Patients with the following arrhythmia on ECG who are considered clinically serious
Complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block
9) Patients with a history of immunotherapy including immunoantibody therapy for malignant tumor
10) Patients with chronic diarrhea
11) Patients with a history of serious drug allergy
12) Patients with uncontrollable diabetes mellitus despite appropriate treatment
13) Pregnant women; breastfeeding women; women who may be pregnant; men who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy; or women of childbearing potential
Refer to inclusion criteria 14)
14) Patients whose enrollment in this study is determined to be difficult due to clinically significant psychiatric disease
15) Patients who may be a donor for transfusion during the study and within 90 days after the last administration of the study drug
16) Patients who have received a live vaccine within 30 days prior to enrollment. Patients who may receive a live vaccine during the study or within 30 days after the last administration of the study drug
17) Other patients who are determined to be inappropriate for the study by the investigator, etc.

Related Information

• Primary Sponsor: Tachihara Motoko