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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.

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511007-41-00
Acronym
BGBC016
Enrollment
52
Registered
2024-08-06
Start date
2023-10-03
Completion date
2025-02-25
Last updated
2025-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutation.

Brief summary

Phase 1b: The incidence of dose limiting toxicities (DLTs) during a 21-day assessment period in treatment cycle 1 (i.e., the first 21 days from cycle 1 day 1 (C1D1) for each subject) Phase 2a: Objective response rate (ORR - complete response and partial response per RECIST 1.1) at 6 and 12 months.

Detailed description

Phase 1b: - ORR (complete response and partial response per RECIST 1.1) Phase 2a: - The frequency and percentage of AEs; assessment of safety laboratory parameters, vital signs, and ECGs per CTCAE, Phase 1b: - Disease control rate (DCR) (complete response, partial response, and stable disease per RECIST 1.1) Phase 2a: - DCR (complete response, partial response, and stable disease), Phase 1b: - Duration of response (DOR) Time of first response to progressive disease as assessed per RECIST 1.1) Phase 2a: - DOR, Phase 1b: - Overall survival Phase 2a: - Progression free survival (PFS), Phase 2a: - Time to progression (TTP), Phase 2a: - Overall survival, Phase 2a: - PK exposure (Cmax, AUC, and t½)

Interventions

DRUGBemcentinib 75 mg
DRUGBemcentinib 50 mg
DRUGPEMETREXED
DRUGPEMBROLIZUMAB
DRUGBemcentinib 100 mg
DRUGCARBOPLATIN

Sponsors

Bergenbio ASA
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase 1b: The incidence of dose limiting toxicities (DLTs) during a 21-day assessment period in treatment cycle 1 (i.e., the first 21 days from cycle 1 day 1 (C1D1) for each subject) Phase 2a: Objective response rate (ORR - complete response and partial response per RECIST 1.1) at 6 and 12 months.

Secondary

MeasureTime frame
Phase 1b: - ORR (complete response and partial response per RECIST 1.1) Phase 2a: - The frequency and percentage of AEs; assessment of safety laboratory parameters, vital signs, and ECGs per CTCAE, Phase 1b: - Disease control rate (DCR) (complete response, partial response, and stable disease per RECIST 1.1) Phase 2a: - DCR (complete response, partial response, and stable disease), Phase 1b: - Duration of response (DOR) Time of first response to progressive disease as assessed per RECIST 1.1) Phase 2a: - DOR, Phase 1b: - Overall survival Phase 2a: - Progression free survival (PFS), Phase 2a: - Time to progression (TTP), Phase 2a: - Overall survival, Phase 2a: - PK exposure (Cmax, AUC, and t½)

Countries

France, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026