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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB27 | Experimental | SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks |
|
| EU sourced Keytruda | Active Comparator | EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks |
|
| US sourced Keytruda | Active Comparator | EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB27 | Drug | Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1 | Defined as AUC calculated in Cycle 1 based on intensive PK assessment | At the end of Cycle 1 (each cycle is 21 days) |
| Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6 | Defined as AUC calculated in Cycle 6 based on intensive PK assessment | At the end of Cycle 6 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SB Investigative Site | Gdansk | Poland | ||||
| SB Investigative Site |
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| EU sourced Keytruda | Drug | Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks |
|
| US sourced Keytruda | Drug | Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks |
|
| Overall Survival | Defined as the time from the date of randomization until the date of death of any cause. | From the date of randomization until the date of death of any cause, assessed up to Week 55 |
| Otwock |
| Poland |
| SB Investigative Site | Ansan | South Korea |
| SB Investigative Site | Busan | South Korea |
| SB Investigative Site | Daegu | South Korea |
| SB Investigative Site | Hwasun | South Korea |
| SB Investigative Site | Incheon | South Korea |
| SB Investigative Site | Jinju | South Korea |
| SB Investigative Site | Seongnam | South Korea |
| SB Investigative Site 3 | Seoul | South Korea |
| SB Investigative Site 4 | Seoul | South Korea |
| SB Investigative Site 5 | Seoul | South Korea |
| SB Investigative Site 6 | Seoul | South Korea |
| SB Investigative Site 1 | Suwon | South Korea |
| SB Investigative Site 2 | Suwon | South Korea |
| SB Investigative Site | Ulsan | South Korea |
| SB Investigative Site | Jaén | Jaén | Spain |
| SB Investigative Site | A Coruña | Santiago de Compostela | Spain |
| SB Investigative Site | Málaga | Spain |
| SB Investigative Site | Adana | Turkey (Türkiye) |
| SB Investigative Site 1 | Ankara | Turkey (Türkiye) |
| SB Investigative Site 2 | Ankara | Turkey (Türkiye) |
| SB Investigative Site | Istanbul | Turkey (Türkiye) |
| SB Investigative Site | Izmir | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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