NCT07908667Not yet recruitingPhase 1
A Study of TRB191 in Patients With Extensive-stage Small Cell Lung Cancer
A Phase I, Open-label, Multi-center Study of TRB191 in Patients With Extensive Stage Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity (IG) and preliminary anti-tumor activity and to determine a recommended dose (RD) of TRB191 in patients with extensive-stage small cell lung cancer (ES-SCLC).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 17 Nov 2026
- Primary completion date
- 6 Aug 2030
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Lung cancer
- NCT number
- NCT07908667
- EudraCT number
- 2026-526463-37
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 120
- From 17 Nov 2026 to the primary completion date, 6 Aug 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of symptomatic central nervous system (CNS) metastases or CNS metastases requiring local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry
- Treatment with anti-cancer therapies prior to the first dose of study treatment within the stated timeframes
Other illness
- Impaired cardiac function or clinically significant cardiac disease
Lab values
- Patients with inadequate bone marrow function and/or organ functions with out-of-range laboratory values
Other
- Pregnant or nursing woman, and women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
- Other protocol-defined inclusion/exclusion criteria may apply.
Who the study is looking for
- Age ≥ 18 years old
- Histologically or cytologically confirmed and documented ES-SCLC
- Dose escalation: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor) according to the local standard of care (SOC). Prior treatment with a DLL3-targeted therapy is allowed, except in cohorts designed to evaluate TRB191 in patients who are naïve to prior DLL3-targeted therapy
- Dose expansion: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor), according to the local SOC. Patients must have received prior treatment with tarlatamab
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.