LOGIK2401(NECTAR Study)

JRCT ID: jRCTs071240054

Registered date:29/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: large cell neuroendcrine carcinoma of the lung
• Date of first enrollment: 06/09/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Carboplatin + etoposide + durvalumab induction therapy shall be performed for 4 courses as 1 course of 3 weeks. Maintenance therapy with durvalumab alone shall be continued until PD is achieved as 1 course of 4 weeks.

Outcome(s)

• Primary Outcome: objective response rate
• Secondary Outcome: duration of response, progression-free survival, 6-month progression-free survival rate, 12-month progression-free survival rate, overall survival, 12-month survival rate, safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Age 18 years and older at the time of obtaining consent
2)ECOG performance status (PS) is 0 - 1
3)Diagnosis of large cell neuroendocrine carcinoma of the lung by cytology or histology
4)Patients with advanced or relapsed stage III or IV for which radical treatment is not possible.
5)Patients had not received systemic chemotherapy.
6)Patients with at least measurable lesions according to RECIST version 1.1.
7)Patients without brain metastases that would be indications for emergency irradiation or surgery.
8)A survival of more than 12 weeks is expected from the date of enrollment.
9)Weights more than 30 kg at enrollment.
10)Written consent to participate in the study has been obtained from the patient after a sufficient explanation of the study content was given before enrollment for this study.

Exclude criteria

1)Patients with active double cancers (synchronous double cancer requiring treatment and metachronous double cancer with a disease-free period within 1 year).
2)Patients who are diagnosed with cancerous meningitis.
3)Patients with localized infection requiring drainage or other surgical measurements or systemic active infection.
4)Patients with a history of primary immunodeficiency syndrome.
5)Patients with active hepatitis B, active hepatitis C and active pulmonary tuberculosis.
6)Patients with evident interstitial lung disease on chest CT.
7)Patients with concomitant autoimmune disease or a history of autoimmune disease requiring steroid therapy.
8)Patients with non-autoimmune diseases requiring continuous systemic administration (oral or intravenous) of steroids at doses higher than 10 mg/day prednisolone equivalent, or patients who are currently using an immunosuppressant, or have used an immunosuppressant within 14 days prior to enrollment. However, patients on steroids equivalent to less than 10 mg/day of prednisolone equivalent and stable for more than 14 days before enrollment may be allowed.
9)Patients with serious complications.
10)Patients whose period of time has not elapsed since the completion of the following prior treatment at the time of enrollment (enrollment shall be possible on the same day of the week)
Surgery : 4 weeks
Palliative radiotherapy : 1 week
Thorax drainage therapy : 1 week

Related Information

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