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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)

Must not have

Has an EGFR Exon 19 Deletion or L858R mutation, EGFR S768I, L861Q, and/or G719X mutations, ALK gene rearrangement, ROS1 rearrangement, rearranged during transfection (RET) rearrangement, NRTK1/2/3, gene fusion, BRAF V600E mutation, METex14 Skipping Mutation

Has received any prior chemotherapy or biological therapy for locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) adenocarcinoma of the lung

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has a specific genetic mutation or rearrangement.

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I have had treatment for advanced lung cancer.

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I had radiation therapy less than 2 weeks ago or still have side effects.

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I have not had major surgery in the last 28 days or have fully recovered from it.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Phase 1b: Disease Control Rate (DCR)

Phase 1b: Duration of Response (DOR)

Phase 1b: Objective Response Rate (ORR)

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6120

Bemcentinib

2018

Completed Phase 2

~170