LOGIK2301(RELIANCE)

JRCT ID: jRCTs071230065

Registered date:15/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 23/10/2023
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Cisplatin + vinorelbine therapy (cisplatin: 60-80 mg/m2, vinorelbine: 20-25 mg/m2) every 3 weeks for up to 4 cycles after complete resection is performed, followed by atezolizumab (1200 mg/body) every 3 weeks for 1 year.

Outcome(s)

• Primary Outcome: Completion rate of protocol treatment
• Secondary Outcome: 1-year disease-free survival, 1-year overall survival, completion rate of platinum-based adjuvant therapy,The rate of receiving atezolizumab, safety profile (rate of adverse events, rate of treatment-related death)

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age >= 75 years at the time of consent acquisition
2) ECOG performance status (PS) 0 to 1
3) Postoperative pathological stage II-III with complete anatomical resection
4) Histologically diagnosed non-small cell lung cancer (excluding neuroendocrine carcinoma, mucoepidermoid carcinoma, and adenoid cystic carcinoma)
5) PD-L1 expression of the tumor specimen is more than 1% (SP263 or 22C3 antibody)
6) No prior non-surgical treatment (radiation therapy, chemotherapy, immunotherapy)
7) No prior treatment with drugs that specifically target T-cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies for other types of cancer
8) Patients must be at least 21 days but not more than 56 days post complete resection at the time of enrollment (based on the date of enrollment, the same day of 3 weeks and 8 weeks prior to enrollment is acceptable).
9) At the time of enrollment, no severe damage to major organs (bone marrow, heart, lungs, liver, kidneys, etc.) and meeting the following criteria (using the most recent data within 14 days of the date of enrollment, with allowance for the same day of the week 14 days earlier):
White blood cell count:>= 3,000 /mm3
Neutrophil count: >= 1,500 /mm3
Hemoglobin :>= 9.0 g/dL
Platelet count :>= 100,000 /mm3
AST, ALT: <= 100 U/L
Total bilirubin: <= 1.5 mg/dL
Creatinine clearance: >= 60 ml/min
PaO2: >= 60 torr or SpO2: >= 90
10) Written informed consent.

Exclude criteria

1) Patients with active double cancers. Double cancers are defined as synchronous double cancer and metachronous double cancer with a disease-free interval of 3 years or less that require treatment. (except for lesions equivalent to intraepithelial/intramucosal carcinoma that are curable by local treatment.)
2) Patients with unrecovered postoperative complications.
3) Patients with a history of hypersensitivity to the drugs used in the protocol treatment.
4) Patients with local infection requiring surgical procedures such as drainage or with active systemic infection
5) Patients with active hepatitis B or active hepatitis C, unless the viral load is below the sensitivity level and without active hepatitis.
6) Patients with interstitial lung disease on CT (however, a history of radiation pneumonitis or organizing disease within the irradiation field is acceptable).
7) Patients with autoimmune disease or a history of autoimmune disease that required steroid therapy. However, patients with autoimmune-related hypothyroidism using stable doses of thyroid replacement hormone and patients with controlled type 1 diabetes mellitus receiving a stable dose of insulin regimen are eligible for the study. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo vulgaris presenting only with dermatological symptoms (e.g., excluding patients with psoriatic arthritis) are eligible if they meet the following criteria: the rash must be less than 10% of body surface area, require only low-titer topical steroids, and had no acute exacerbation of underlying symptoms within the past 12 months.
8) Patients with continuous systemic administration of steroids at doses higher than 10 mg/day equivalent to prednisolone or patients taking immunosuppressants. Patients taking oral steroids equivalent to less than 10 mg/day of prednisolone are allowed.
9) atients with serious complications, frequent transient ischemic attacks, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past year, clinically significant arrhythmia on ECG, gastrointestinal complications, uncontrolled diabetes mellitus, uncontrolled peptic ulcer, or other clinically problematic conditions.
10) Patients with psychiatric disorders that would interfere with participation in the study.
11)Pregnant or lactating women, women who may be currently pregnant, and individuals unwilling to use contraception during the treatment period.
12) Other cases deemed inappropriate by the investigator.

Related Information

• Primary Sponsor: Yamaguchi Masafumi
• Source(s) of Monetary Support: CHUGAI PHARMACEUTICAL CO.,LTD.