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Small Molecule Inhibitor
Bemcentinib; pembrolizumab for Lung Adenocarcinoma
Phase 2
Waitlist Available
Research Sponsored by BerGenBio ASA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining bemcentinib with pembrolizumab, to see if it is effective and safe in people with advanced lung cancer who have previously been treated with other therapies.
Eligible Conditions
- Lung Adenocarcinoma
- Lung Cancer
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Disease Control Rate
Duration of Response
Number of Participants with Clinical Laboratory, Vital Signs, and Electrocardiogram (ECG) Abnormalities
+6 moreOther outcome measures
Correlation of response rate with baseline biomarker
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bemcentinib + pembrolizumabExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bemcentinib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
BerGenBio ASALead Sponsor
13 Previous Clinical Trials
791 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,977 Total Patients Enrolled
Frequently Asked Questions
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