55 Participants NeededMy employer runs this trial

Obrixtamig + Pumitamig for Small Cell Lung Cancer

Recruiting at 26 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Boehringer Ingelheim
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well people with extensive-stage small cell lung cancer tolerate a new combination of medicines, obrixtamig and pumitamig. The goal is to determine if these medicines, which enhance the immune system's ability to fight cancer, can shrink tumors. Participants are divided into two groups: one receives only the new medicines, while the other receives the new medicines plus standard chemotherapy. This trial may suit those with extensive-stage lung cancer who have either already undergone chemotherapy or are about to begin their first treatment. Regular visits to the trial site are required, including some overnight stays. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of obrixtamig and pumitamig is generally well-tolerated. Previous studies found that pumitamig is safe for treating small cell lung cancer (SCLC). For example, one study showed that 76.3% of patients responded well to the treatment when combined with chemotherapy, indicating its effectiveness for most people without causing severe problems.

When obrixtamig and pumitamig are used with chemotherapy, the safety remains acceptable. However, some treatment-related side effects have been reported. Serious side effects, such as infections, have occurred but remain relatively rare.

Overall, evidence suggests that many patients can tolerate these treatments, though side effects may occur. Regular monitoring during the trial will help manage any issues that arise.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Obrixtamig and Pumitamig for treating small cell lung cancer because these treatments offer a novel approach that differs from typical chemotherapy. Most standard treatments for small cell lung cancer involve using platinum-based chemotherapy, like carboplatin and etoposide, which can be effective but often lead to progression after some time. Obrixtamig and Pumitamig provide a fresh mechanism by targeting specific cancer pathways, potentially enhancing effectiveness and reducing resistance compared to traditional therapies. The combination therapy, especially in Cohort 2, integrates these novel agents with standard chemotherapy, potentially offering a more comprehensive attack on the cancer.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

Research has shown that obrixtamig and pumitamig are designed to help the immune system fight cancer. In this trial, participants in Cohort 1 will receive the combination of obrixtamig and pumitamig, which early results suggest can shrink tumors in patients with small cell lung cancer. Meanwhile, participants in Cohort 2 will receive the combination of obrixtamig, pumitamig, and chemotherapy (carboplatin and etoposide), which might work even better. Although researchers are still studying these treatments, initial data are promising in reducing tumor size. Researchers closely monitor participants to ensure their safety and track any changes in their cancer.

Are You a Good Fit for This Trial?

This trial is for adults with advanced (extensive-stage) small cell lung cancer. Participants must be able to visit the study site regularly and tolerate intravenous treatments. People with other serious health issues or who can't safely receive these medicines may not qualify.

Inclusion Criteria

Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses
Availability of an archival tumour sample (except China)
I have at least one tumor outside my brain or spine that can be measured on scans.
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Exclusion Criteria

Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers or laboratory abnormalities that may impact patient safety, compliance, or assessment validity
Known hypersensitivity to trial drugs or excipients, prior severe or life-threatening hypersensitivity to monoclonal antibodies, or significant risk of allergic/anaphylactic reactions to investigational drugs
I have received an organ or tissue transplant.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive obrixtamig and pumitamig, with or without standard chemotherapy, as infusions into a vein. Regular site visits and some overnight stays are required.

up to 2 years
Regular visits with some overnight stays

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tumor size monitoring and laboratory tests.

up to 44 months

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Etoposide
  • Obrixtamig
  • Pumitamig

Trial Overview

The study tests two new immune-based drugs, obrixtamig and pumitamig, alone or combined with standard chemotherapy (carboplatin and etoposide). Treatments are given by IV infusion, and participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment4 Interventions
Group II: Cohort 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

BioNTech SE

Industry Sponsor

Trials
84
Recruited
120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Citations

Boehringer-BioNTech partnership to advance SCLC therapy

In a global Phase II first‑line ES‑SCLC study in combination with chemotherapy, pumitamig demonstrated a 76.3% confirmed objective response rate ...

Pumitamig Plus Elfetabart Drozuntecan Shows ...

Investigators concluded that the combination showed a manageable safety profile with encouraging early efficacy in SCLC, supporting further ...

NCT06712355 | Safety and Efficacy of BNT327, an ...

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40706016/

Phase I Dose-Escalation Results for the Delta-Like Ligand ...

Results: As of February 21, 2024, 168 patients received obrixtamig, 72% received ≥2 lines of previous anticancer therapy, and 51% received ...

Safety and Preliminary Efficacy of Pumitamig (BNT327), an ...

This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer ( ...