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 : April 4, 2019
|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 :||77 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 :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Bemcentinib + pembrolizumab
Cohort A enrols patients 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 enrols patients with a maximum of 2 prior lines whereas the most recent line must have included a PD-(L)1 inhibitor to receive bemcentinib (BGB324) in combination with pembrolizumab.
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 patient's 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 patients 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 patients 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 patients with a partial or complete response and is measured from the date of response until the cancer progresses (worsens).
- Time to Progression [ 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). ]Time to Progression is measured from the date of first dose until the date the cancer progresses (worsens) and includes all patients.
- 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 patient is last known to be alive. It includes all patients.
- Number of patients 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 patients with each adverse event will be summarised.
- Correlation of response rate with baseline biomarker [ Time Frame: The biomarkers are collected at screening; the response rate is the best improvement or change in a patient's cancer burden, as measured from baseline (screening) and then again at regular intervals, over the whole study (an average of 24 months). ]Biomarkers (Axl kinase and PD-L1 expression) will be measured at screening using a diagnostic test. The response rate will be summarised according to biomarker status (positive or negative) and includes all patients.
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|