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New combo therapy targets tough lung cancer in early trial

NCT ID NCT05595460

Disease control Sponsor: RayzeBio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new drug called RYZ101 added to standard chemotherapy and immunotherapy for people with a specific type of advanced small cell lung cancer that has spread. The main goals are to check safety and find the best dose. About 21 adults who have not had treatment yet will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

21 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA * Age of at least 18 years at the time of signing the informed consent. * Cytologically or histologically confirmed ES-SCLC (American Joint Committee on Cancer \[AJCC\] 8th edition) and is untreated or received ≤1 cycle of platinum-etoposide and PD-L1 inhibitor therapy. It is acceptable to omit the first dose of PD-L1 inhibitor therapy due to logistical reasons if receiving SoC during or prior to the start of the screening period. * Subject is a candidate for therapy with SoC which includes: * Carboplatin for a maximum of 4 cycles * Etoposide for a maximum of 4 cycles * Atezolizumab * At least 1SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and ≥50% of RECIST v1.1 measurable metastatic lesions must be SSTR-imaging positive. * Adequate hematologic, renal and hepatic function EXCLUSION CRITERIA * Prior exposure to immune-mediated therapy, * Known active or suspected autoimmune disease or any condition requiring systemic treatment with immunosuppressive medications within 14 days prior to first dose of study drug * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. Note: History of radiation pneumonitis is permitted. * Severe infection within 4 weeks and/or treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of study treatment. * Prior allogeneic stem cell or solid organ transplantation. * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab. * Radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care is allowed but must be completed \>2 weeks prior to first dose of study drug. * Significant cardiovascular disease and/or resistant hypertension * Subjects with previously treated central nervous system (CNS) metastases who have not recovered from acute side effects of radiotherapy.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SCLC,extensive stage

Contacts and locations

Locations

  • Research Facility

    Los Angeles, California, 90024, United States

  • Research Facility

    San Francisco, California, 94158, United States

  • Research Facility

    Jacksonville, Florida, 32224, United States

  • Research Facility

    Miami, Florida, 33136, United States

  • Research Facility

    Orlando, Florida, 32806, United States

  • Research Facility

    Iowa City, Iowa, 52242, United States

  • Research Facility

    Grand Rapids, Michigan, 49503, United States

  • Research Facility

    Rochester, Minnesota, 55905, United States

  • Research Facility

    St Louis, Missouri, 63130, United States

  • Research Facility

    Omaha, Nebraska, 68130, United States

  • Research Facility

    Salt Lake City, Utah, 84112, United States

  • Research Facility

    San Juan, Puerto Rico, 00935, Puerto Rico

  • Reserach Facility

    Lexington, Kentucky, 40536, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.