A Study to Test Obrixtamig in Combination With Pumitamig in People With Advanced Small Cell Lung Cancer (Dareon®-Rosetta35)

Conditions

• Advanced Small Cell Lung Cancer
• Extensive-stage Small Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Obrixtamig — DRUG
  Obrixtamig
• Pumitamig — DRUG
  Pumitamig
• Carboplatin — DRUG
  Carboplatin
• Etoposide — DRUG
  Etoposide

Study Details

This study is open to adults with extensive-stage small cell lung cancer. The purpose of this study is to find out how well people with this type of cancer tolerate taking study medicines called obrixtamig and pumitamig. Another purpose is to check whether the combination study treatment can make tumours shrink. Obrixtamig and pumitamig are being developed to help the immune system fight cancer. Participants are put into 2 groups. One group gets obrixtamig and pumitamig. The other group gets obrixtamig and pumitamig with standard chemotherapy (carboplatin and etoposide). All study treatments are given as infusions into a vein. This study does not have a fixed duration. Participants can receive obrixtamig and pumitamig for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.

Key Dates

First listed

Sep 28, 2026

Start date

Oct 1, 2026

Status verified

Oct 2026

Primary completion

Apr 17, 2030

Completion

Apr 21, 2030

Study Design

Enrollment

55 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Combination of obrixtamig and pumitamig in patients with extensive stage small cell lung carcinoma (ES-SCLC) who progressed on or after a platinum-containing first line (1L) treatment or on or after one additional line of therapy (second line (2L) or third line (3L) patients).
• Experimental: Cohort 2
  Combination of obrixtamig, pumitamig and chemotherapy (i.e., carboplatin and etoposide) in 1L ES-SCLC patients.

Primary Outcome Measure

Occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification [ Time Frame: up to 27 months ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (5)

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