Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC
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|ClinicalTrials.gov Identifier: NCT03184571|
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : October 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Metastatic NSCLC Stage IV Adenocarcinoma of Lung||Drug: Bemcentinib; pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Extension to Simon's 2-stage design allowing termination at the end of Stage 1 for either futility or efficacy.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Multi Center Study of BGB324 in Combination With Pembrolizumab in Patients With Previously Treated Advanced Adenocarcinoma of the Lung|
|Actual Study Start Date :||October 17, 2017|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: Bemcentinib + pembrolizumab
Cohort A enrols participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Cohort B enrolls participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Cohort C enrolls participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
Drug: Bemcentinib; pembrolizumab
Bemcentinib is a selective Axl kinase inhibitor; pembrolizumab is a PD-1 inhibitor
Other Name: BGB324; Keytruda
- Objective Response Rate [ Time Frame: The disease response is the best improvement or change in a participants cancer burden, as measured from baseline (screening) and then measured again at regular intervals over the whole period of the study, an average of 24 months. ]Objective Response Rate includes all participants who have a partial or complete response.
- Disease Control Rate [ Time Frame: Disease response is assessed every 9 weeks for the first 45 weeks and then every 12 weeks until disease progression (worsens) or study completion, an average of 24 months. ]Disease Control Rate includes all participants who have a partial or complete response, or who maintain stable disease.
- Duration of Response [ Time Frame: Disease response is assessed every 9 weeks for the first 45 weeks and then every 12 weeks until disease progression or study completion, an average of 24 months. ]Duration of response includes participants with a partial or complete response and is measured from the date of response until the cancer progresses (worsens).
- Progression-free Survival (PFS) [ Time Frame: Disease assessments are conducted at screening and then every 9 weeks for the first 45 weeks and then every 12 weeks until disease progression or death, whichever comes first, up to study completion (an average of 24 months) ]PFS is measured from the date of the 1st dose of the 1st cycle until the date of progression (the date on which the progression is initially observed) or the date of death (whichever is earlier).
- Overall survival [ Time Frame: Survival visits are conducted every 12 weeks after disease progression until death or until study completion (an average of 24 months). ]Time to death is measured from the date of first dose until the date of death or the date the participants is last known to be alive. It includes all participants.
- Number of participants with Adverse Events (as assessed by CTCAE v4.03) [ Time Frame: Adverse events are collected from the date of consent until up to 120 days after cessation of both treatments. ]The number of participants with each adverse event will be summarized.
- Pharmacokinetic (PK) Parameters: Maximum observed concentration (Cmax) [ Time Frame: Up to 106 weeks ]Cmax defined as the maximum observed concentration.
- PK Parameters: Area Under the Curve (AUC) [ Time Frame: Up to 106 weeks ]AUC defined as the area under the concentration versus time curve.
- PK Parameters: Elimination Half-life (T½) [ Time Frame: Up to 106 weeks ]T½ defined as the elimination half-life.
- Number of Participants with Clinical Laboratory, Vital Signs, and Electrocardiogram (ECG) Abnormalities [ Time Frame: 106 weeks ]Number of participants with clinical laboratory (hematology, including coagulation, urinalysis), vital signs (temperature, systolic blood pressure, diastolic blood pressure, heart rate, and respiratory rate), and ECG abnormalities will be reported.
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): NCT03184571
|Contact: BerGenBio Clinical Team||+47 559 61 firstname.lastname@example.org|
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center (DHMC)||Not yet recruiting|
|Lebanon, New Hampshire, United States, 03756|
|Contact: Konstantin Dragnev, MD|
|United States, Wisconsin|
|Medical College of Wisconsin, 9200 W Wisconsin Avenue||Recruiting|
|Milwaukee, Wisconsin, United States, 53226-3522|
|Contact: Carlo Arce-Lara, MD email@example.com|
|Radiumhospitalet, Oslo University Hospital PB||Recruiting|
|Oslo, Norway, 0424|
|Contact: Paal Brunsvig, MD firstname.lastname@example.org|
|Hospital Universitari Germans Trias i Pujol-ICO||Recruiting|
|Barcelona, Badalona, Spain, 08916|
|Contact: Eric Carcereny, MD +34 661 32 81 61 email@example.com|
|Servicio de Oncologia Hospital del Mar||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Edume Arriola, MD +34 93 248 31 37 firstname.lastname@example.org|
|Hospital Universitario Vall d'Hebron (VHIR)||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Enriqueta Felip, MD +34 93 274 60 77 email@example.com|
|Hospital Clinic Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Nuria Vinolas Segarra, MD|
|Contact +34 93 227 54 02 firstname.lastname@example.org|
|Hospital Teresa Herrera||Recruiting|
|Coruna, Spain, 15006|
|Contact: Maria R Garcia Campelo, MD +34 98 117 8000 ext 292850 email@example.com|
|Hospital Universitario Fundacion Jimene Diaz||Recruiting|
|Madrid, Spain, 28040|
|Contact: Manuel Domine Gomez, MD +34 91 550 48 00 ext 2649 firstname.lastname@example.org|
|Hospital Universitario 12 de Octubre, Servicio de oncologia||Recruiting|
|Madrid, Spain, 28041|
|Contact: Luis Paz Ares, MD email@example.com|
|Hospital Universitario Virgen de la Victoria||Recruiting|
|Málaga, Spain, 29010|
|Contact: Jose Manuel Trigo Perez, MD|
|Contact +34 95 103 22 49 firstname.lastname@example.org|
|Guy's and St Thomas' NHS Foundation Trust||Recruiting|
|London, United Kingdom, SE1 9RT|
|Contact: James Spicer, MD +44(0)2071884260 email@example.com|
|Christie NHS Hospital Foundation Trust||Recruiting|
|Manchester, United Kingdom, M20 4BX|
|Contact: Matthew Krebs, MD +44(0)161 918 7871 firstname.lastname@example.org|