Study of KN046 With Chemotherapy in First Line Advanced NSCLC
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|ClinicalTrials.gov Identifier: NCT04054531|
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : September 10, 2019
This is a phase II study of KN046 plus platinum-based doublet chemotherapy in previously untreated advanced non-squamous and squamous NSCLC subjects.
The study will assess primarily the safety and efficacy of KN046 plus platinum-based doublet chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Biological: KN046 Drug: Paclitaxel Drug: Pemetrexed Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Phase II Study of KN046 Evaluating the Efficacy and Safety of KN046 Plus Platinum-based Doublet Chemotherapy as First Line Therapy in Advanced Non-small Cell Lung Cancer Subjects.|
|Actual Study Start Date :||September 4, 2019|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: KN046 + carboplatin/paclitaxel
KN046 5 mg/kg IV every three weeks (Q3W) +Carboplatin AUC5 IV Q3W x 4 cycles + Paclitaxel 500 mg/m2 IV Q3W x 4 cycles
Experimental: KN046 + carboplatin/pemetrexed
KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles
- Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 12 months ]ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1. ORR.
- Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 12 months ]For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death.
- Number of Participants Who Experienced a treatment-emergent adverse event (TEAE) [ Time Frame: Up to approximately 12 months ]TEAE was defined any treatment emergent adverse event.
- Number of Participants Who Experienced an immune-related AE (irAE) [ Time Frame: Up to approximately 12 months ]irAE was defined any immune-related adverse event (AE).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054531
|Contact: Yun Peng Yang, Doctorfirstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 51000|
|Contact: Yun peng Yang, Doctor|