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Kinase Inhibitor

Bemcentinib + Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by BerGenBio ASA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically-confirmed or cytologically confirmed diagnosis of stage of advanced (Stage IIIb/IIIC) or metastatic (Stage IV) (AJCC, Edition 8) non-squamous NSCLC with STK11 mutation, not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (phase 2a)

Histologically-confirmed or cytologically confirmed diagnosis of advanced (Stage IIIb/IIIc) or metastatic (Stage IV) (AJCC Edition 8) non-squamous NSCLC not amenable to curative therapy, irrespective of PD-L1 status and without actionable mutations (Phase 1b)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

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

Who is the study for?

Adults with untreated advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that can't be cured by surgery or radiation, specifically those with STK11 mutation and no EGFR, ALK, ROS1, RET rearrangements, NRTK gene fusions, BRAF V600E or METex14 Skipping Mutations. Participants should not have had previous chemotherapy for their lung cancer.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of Bemcentinib in combination with Pembrolizumab plus Pemetrexed and Carboplatin as a first-line treatment. The goal is to find the best dose for phase 2 trials and see how well this combo works against NSCLC with STK11 mutations.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue from treatment-induced exhaustion, digestive issues like nausea or diarrhea, blood disorders affecting cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced non-small cell lung cancer is confirmed and cannot be cured with surgery.

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My lung cancer is advanced or has spread, and cannot be cured with surgery.

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I haven't had any systemic treatment for my advanced lung cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)

Phase 2a: Objective Response Rate (ORR) at 12 Months

Phase 2a: Objective Response Rate (ORR) at 6 Months

Secondary outcome measures

Phase 1b: Disease Control Rate (DCR)

Phase 1b: Duration of Response (DOR)

Phase 1b: Objective Response Rate (ORR)

+11 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase 2a Expansion Cohort: Bemcentinib (at 2 doses as determined from Phase 1b)Experimental Treatment4 Interventions

Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (Pembrolizumab infusion followed by pemetrexed and carboplatin).

Group II: Phase 1b Cohort 3: Bemcentinib Dose 3Experimental Treatment4 Interventions

Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib dose 3 once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (Pembrolizumab infusion followed by pemetrexed and carboplatin).

Group III: Phase 1b Cohort 2: Bemcentinib Dose 2Experimental Treatment4 Interventions

Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib dose 2 once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (Pembrolizumab infusion followed by pemetrexed and carboplatin).

Group IV: Phase 1b Cohort 1: Bemcentinib Dose 1Experimental Treatment4 Interventions

Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib dose 1 once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (Pembrolizumab infusion followed by pemetrexed and carboplatin).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Bemcentinib

2018

Completed Phase 2

~160

Pembrolizumab

2017

Completed Phase 2

~2010

Pemetrexed

2014

Completed Phase 3

~5250

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BerGenBio ASALead Sponsor

13 Previous Clinical Trials

833 Total Patients Enrolled

Media Library

Bemcentinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05469178 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: Phase 1b Cohort 3: Bemcentinib Dose 3, Phase 1b Cohort 1: Bemcentinib Dose 1, Phase 1b Cohort 2: Bemcentinib Dose 2, Phase 2a Expansion Cohort: Bemcentinib (at 2 doses as determined from Phase 1b)

Non-Small Cell Lung Cancer Clinical Trial 2023: Bemcentinib Highlights & Side Effects. Trial Name: NCT05469178 — Phase 1 & 2

Bemcentinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05469178 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety, Tolerability, and Preliminary Anti-tumor Activity of Bemcentinib in Combination With Pembrolizumab Plus Pemetrexed and Carboplatin in Adult Participants With Untreated Non-squamous Non-small Cell Lung Cancer

2022. "A Study to Investigate the Safety, Tolerability, and Preliminary Anti-tumor Activity of Bemcentinib in Combination With Pembrolizumab Plus Pemetrexed and Carboplatin in Adult Participants With Untreated Non-squamous Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05469178.

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