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Phase 1b Cohort 3: Bemcentinib Dose 3 for Non-Small Cell Lung Cancer

Mount Sinai Comprehensive Cancer Center, Miami Beach, FL
Non-Small Cell Lung CancerBemcentinib - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial tests safety and effectiveness of a drug combo to treat advanced non-squamous lung cancer with or without STK11 mutations.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Palliative Radiation Therapy

Study Objectives

3 Primary · 14 Secondary · Reporting Duration: Up to 2 years

12 months
Phase 2a: Objective Response Rate (ORR) at 12 Months
6 months
Phase 2a: Objective Response Rate (ORR) at 6 Months
Day 21
Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)
Day 21
Phase 2a: Apparent Terminal Half-life (t1/2)
Phase 2a: Area Under the Curve Within a Dosing Interval (AUC[0-t])
Phase 2a: Observed Maximum Plasma Concentration After Single Dose Administration (Cmax)
Up to 2 years
Phase 1b: Disease Control Rate (DCR)
Phase 1b: Duration of Response (DOR)
Phase 1b: Objective Response Rate (ORR)
Phase 1b: Overall Survival (OS)
Up to 26 months
Phase 2a: Disease Control Rate (DCR)
Phase 2a: Duration of Response (DOR)
Phase 2a: Number of Participants with Abnormalities in Safety Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs)
Phase 2a: Number of Participants with Adverse Events (AEs)
Phase 2a: Overall Survival (OS)
Phase 2a: Progression Free Survival (PFS)
Phase 2a: Time to Progression (TTP)

Trial Safety

Phase-Based Safety

1 of 3

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Cyclical Hypofractionated Palliative Radiation (Quad Shot)
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

7 Treatment Groups

Phase 1b Cohort 3: Bemcentinib Dose 3
1 of 7
Phase 1b Cohort 1: Bemcentinib Dose 1
1 of 7
Phase 1b Cohort 2: Bemcentinib Dose 2
1 of 7
Phase 1b Cohort 2: Bemcentinib 100 mg
1 of 7
Phase 1b Cohort 3: Bemcentinib 150 mg
1 of 7
Phase 2a Expansion Cohort: Bemcentinib (at 2 doses as determined from Phase 1b)
1 of 7
Phase 1b Cohort 1: Bemcentinib 75 mg
1 of 7

Experimental Treatment

64 Total Participants · 7 Treatment Groups

Primary Treatment: Phase 1b Cohort 3: Bemcentinib Dose 3 · No Placebo Group · Phase 1 & 2

Phase 1b Cohort 3: Bemcentinib Dose 3Experimental Group · 4 Interventions: Bemcentinib, Carboplatin, Pembrolizumab, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug
Phase 1b Cohort 1: Bemcentinib Dose 1Experimental Group · 4 Interventions: Bemcentinib, Carboplatin, Pembrolizumab, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug
Phase 1b Cohort 2: Bemcentinib Dose 2Experimental Group · 4 Interventions: Bemcentinib, Carboplatin, Pembrolizumab, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug
Phase 1b Cohort 2: Bemcentinib 100 mgExperimental Group · 4 Interventions: Bemcentinib, Carboplatin, Pembrolizumab, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug
Phase 1b Cohort 3: Bemcentinib 150 mgExperimental Group · 4 Interventions: Bemcentinib, Carboplatin, Pembrolizumab, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug
Phase 2a Expansion Cohort: Bemcentinib (at 2 doses as determined from Phase 1b)Experimental Group · 4 Interventions: Bemcentinib, Carboplatin, Pembrolizumab, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug
Phase 1b Cohort 1: Bemcentinib 75 mgExperimental Group · 4 Interventions: Bemcentinib, Carboplatin, Pembrolizumab, Pemetrexed · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bemcentinib
2018
Completed Phase 2
~160
Carboplatin
2014
Completed Phase 3
~6500
Pembrolizumab
2017
Completed Phase 3
~2200
Pemetrexed
2014
Completed Phase 3
~4270

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

BerGenBio ASALead Sponsor
13 Previous Clinical Trials
843 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Are there still vacancies in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this trial is currently seeking enrolment of 64 participants from a single site. The initial posting date was December 14th 2022 and the data were last updated on April 18th 2023." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment limit for this investigation?

"Affirmative. Data on clinicaltrials.gov indicates that the current recruitment of participants for this medical study commenced in December 14th, 2022 and was most recently updated April 18th, 2023. The trial is seeking to recruit 64 individuals from one site." - Anonymous Online Contributor

Unverified Answer

What aim is this medical experiment attempting to accomplish?

"The principal aim of this clinical trial, lasting for approximately 12 months, is to measure the Objective Response Rate (ORR) at 6 Months. Secondary goals include assessing Disease Control Rates (DCR), Area Under the Curve Within a Dosing Interval (AUC[0-t]), and Apparent Terminal Half-life (t1/2)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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