Obrixtamig + Standard Treatment for Small Cell Lung Cancer

Recruiting at 231 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must be taking: Carboplatin, Etoposide, Atezolizumab

Must not be taking: Glucocorticoids, Immunosuppressive drugs

Disqualifiers: Leptomeningeal disease, Carcinomatous meningitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

Duration: Up to 36 months

670 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.

Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.

Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have untreated brain metastases that are stable without steroids or seizure medicine.

I can safely receive standard first-line chemo and immunotherapy for my cancer.

I have been diagnosed with extensive-stage small cell lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous infusions of obrixtamig in combination with atezolizumab, carboplatin, and etoposide or standard treatment alone

Up to 36 months

Regular visits, with overnight stays for the first 2 obrixtamig treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Extension/Long-term follow-up

Participants may continue to be monitored for overall survival and progression-free survival

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Carboplatin
• Etoposide
• Obrixtamig

How Is the Trial Designed?

Group I: obrixtamig + atezolizumab, carboplatin, and etoposide treatment arm Experimental Treatment 4 Interventions

Group II: atezolizumab, carboplatin, and etoposide control arm Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+