Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage IIIA
Conditions
Brief summary
The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is: • What the body does to the study drug, which is called pharmacokinetic Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected. Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda.
Interventions
DRUGSB27
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
DRUGEU sourced Keytruda
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
DRUGUS sourced Keytruda
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 years or older * Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery) * Have completely removed all of the cancer from the body surgically * Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery
Exclusion criteria
* Have received anti-cancer therapy before surgery * Have or had autoimmune disease in past 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1 | At the end of Cycle 1 (each cycle is 21 days) | Defined as AUC calculated in Cycle 1 based on intensive PK assessment |
| Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6 | At the end of Cycle 6 (each cycle is 21 days) | Defined as AUC calculated in Cycle 6 based on intensive PK assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | From the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first, assessed up to Week 55 | Defined as the time from the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first. |
| Overall Survival | From the date of randomization until the date of death of any cause, assessed up to Week 55 | Defined as the time from the date of randomization until the date of death of any cause. |
Countries
Poland, South Korea, Spain, Turkey (Türkiye)
Outcome results
None listed