Back to resultsA 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
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bemcentinib
Pembrolizumab
Pemetrexed
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
Main Inclusion Criteria:
- 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)
- 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)
- Have not received prior systemic treatment for their advanced/metastatic NSCLC
- Have measurable disease per RECIST 1.1 as assessed by the investigator
Main Exclusion Criteria:
- Has received any prior chemotherapy or biological therapy for locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) adenocarcinoma of the lung
- 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
- Received radiation therapy within 2 weeks prior to starting study treatment or has not recovered (i.e. <=Grade 1 at baseline) from AEs due to a previous radiation therapy
- Major surgery within 28 days prior to start of study treatment and failure to have recovered adequately from the complications of the surgery/intervention prior to the first dose of study treatment
Sites / Locations
- Mount Sinai Comprehensive Cancer CenterRecruiting
- Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of MarylandRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- Tennessee Oncology PLLCRecruiting
- UT Southwestern Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Phase 1b Cohort 1: Bemcentinib Dose 1
Phase 1b Cohort 2: Bemcentinib Dose 2
Phase 1b Cohort 3: Bemcentinib Dose 3
Phase 2a Expansion Cohort: Bemcentinib (at 2 doses as determined from Phase 1b)
Arm Description
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).
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).
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).
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).
Outcomes
Primary Outcome Measures
Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)
DLT will be graded using NCI CTCAE Version 5.0 based on the Investigator assessment.
Phase 2a: Objective Response Rate (ORR) at 6 Months
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.
Phase 2a: Objective Response Rate (ORR) at 12 Months
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05469178
Brief Title
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
Official Title
Phase 1b/2a Safety and Tolerability Study of Bemcentinib With Pembrolizumab/Carboplatin/Pemetrexed in Subjects With Untreated Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Without/With a STK11 Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
August 11, 2025 (Anticipated)
Study Completion Date
August 11, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BerGenBio ASA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of this study is to determine the safety and tolerability of the combination of bemcentinib with chemo-immunotherapy (CIT) to identify the recommended phase 2 dose (RP2D) when administered as first line (1L) treatment in participants with locally advanced (Stage IIIb/IIIC) or metastatic (Stage IV) non-squamous NSCLC with no actionable mutations and to determine the anti-tumor activity of the combination of bemcentinib with CIT when administered as 1L treatment in participants with locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC with serine/threonine kinase 11 (STK11) mutation and no actionable mutations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase 1b Cohort 1: Bemcentinib Dose 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Phase 1b Cohort 2: Bemcentinib Dose 2
Arm Type
Experimental
Arm Description
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).
Arm Title
Phase 1b Cohort 3: Bemcentinib Dose 3
Arm Type
Experimental
Arm Description
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).
Arm Title
Phase 2a Expansion Cohort: Bemcentinib (at 2 doses as determined from Phase 1b)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Bemcentinib
Intervention Description
Bemcentinib capsules will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab will be administered as an IV infusion as part of CIT every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks.
Primary Outcome Measure Information:
Title
Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)
Description
DLT will be graded using NCI CTCAE Version 5.0 based on the Investigator assessment.
Time Frame
Cycle 1 (the first 21 days of treatment)
Title
Phase 2a: Objective Response Rate (ORR) at 6 Months
Description
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.
Time Frame
6 months
Title
Phase 2a: Objective Response Rate (ORR) at 12 Months
Description
ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
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)
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)
Have not received prior systemic treatment for their advanced/metastatic NSCLC
Have measurable disease per RECIST 1.1 as assessed by the investigator
Main Exclusion Criteria:
Has received any prior chemotherapy or biological therapy for locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) adenocarcinoma of the lung
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
Received radiation therapy within 2 weeks prior to starting study treatment or has not recovered (i.e. <=Grade 1 at baseline) from AEs due to a previous radiation therapy
Major surgery within 28 days prior to start of study treatment and failure to have recovered adequately from the complications of the surgery/intervention prior to the first dose of study treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BerGenBio Clinical Team
Phone
+47 559 61 159
Email
trialsites@bergenbio.com
Facility Information:
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Name
Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the article, after deidentification [text, tables, figures and appendices].
Learn more about this trial
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
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