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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469178
• Other study ID #: BGBC016
• Secondary ID: 2019-003806-28
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 14, 2022
• Est. completion date: August 11, 2025

Study information

• Verified date: October 2023
• Source: BerGenBio ASA
• Contact: BerGenBio Clinical Team
• Phone: +47 559 61 159
• Email: trialsites[@]bergenbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: August 11, 2025
• Est. primary completion date: August 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Bemcentinib
Bemcentinib capsules will be administered orally.
• Pembrolizumab
Pembrolizumab will be administered as an IV infusion as part of CIT every 3 weeks.
• Pemetrexed
Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks.
• Carboplatin
Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks.

Locations

Country	Name	City	State
United States	Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland	Baltimore	Maryland
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Tennessee Oncology PLLC	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
BerGenBio ASA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Cycle 1 (the first 21 days of treatment)
Primary	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.	6 months
Primary	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.	12 months