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A Phase Ib/II, open-label, safety and tolerability trial of intravenous obrixtamig in combination with pumitamig and standard of care (carboplatin, etoposide) in patients with extensive stage small cell lung carcinoma.

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525459-99-00
Enrollment
12
Registered
2026-10-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-27

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

Conditions

Small cell lung carcinoma

Brief summary

Occurrence of treatment-emergent AEs leading to trial medication discontinuation or dose modification.

Detailed description

Occurrence of DLTs during the DLT evaluation period, Occurrence of treatment-emergent DLTs, Occurrence of treatment-emergent AESIs, Occurrence of treatment-emergent AEs CTCAE Grade ≥3, Objective response (OR) is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator assessments) from the first IMP administration until the earliest date of disease progression, death, last evaluable tumour assessment before the start of the next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent, Duration of response (DoR), defined as the time from the first documented OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed objective response based on investigator assessments, Disease control(DC), defined as best overall response of complete response(CR) or partial response(PR) or stable disease (SD) where best overall response is defined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 based on investigator assessments from the first IMP administration until the earliest date of disease progression, death or last evaluable tumour assessment before start of the next line of anti-cancer treatment, loss to follow-up or withdrawal of consent, Progression-free survival (PFS) is defined as the time from first IMP administration until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first

Interventions

DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGRoActemra 20 mg/mL concentrate for solution for infusion
DRUGBNT327

Sponsors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence of treatment-emergent AEs leading to trial medication discontinuation or dose modification.—

Secondary

MeasureTime frame
Occurrence of DLTs during the DLT evaluation period, Occurrence of treatment-emergent DLTs, Occurrence of treatment-emergent AESIs, Occurrence of treatment-emergent AEs CTCAE Grade ≥3, Objective response (OR) is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator assessments) from the first IMP administration until the earliest date of disease progression, death, last evaluable tumour assessment before the start of the next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent, Duration of response (DoR), defined as the time from the first documented OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed objective response based on investigator assessments, Disease control(DC), defined as best overall response of complete response(CR) or partial response(PR) or stable disease (SD) where best overall response —

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 28, 2026