Last Update: Nov 13, 2026 A Phase I, Open-label, Multi-center Study of TRB191 in Patients With Extensive Stage Small Cell Lung Cancer ClinicalTrials.gov Identifier: [NCT07908667](https://clinicaltrials.gov/ct2/show/NCT07908667) Novartis Reference Number:CTRB191A12101 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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). This is a phase I, open-label, multi-center, first-in-human (FIH) study of TRB191 in adult patients with ES-SCLC. The study is comprised of a dose escalation part followed by a dose expansion part in second-line and beyond (2L+) ES-SCLC patients. Condition Extensive-stage Small Cell Lung Cancer Phase Phase1 Overall Status Recruiting Number of Participants120 Start Date Nov 17, 2026 Completion Date Jul 30, 2030 Gender All Age(s) 18 Years - (Adult, Older Adult) ## Interventions Drug ### TRB191 Subcutaneous injection of TRB191 ## Eligibility Criteria Inclusion Criteria: \* 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 Exclusion Criteria: \* Patients with inadequate bone marrow function and/or organ functions with out-of-range laboratory values \* Impaired cardiac function or clinically significant cardiac disease \* 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 \* 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. Israel #### Novartis Investigative Site Recruiting Tel Aviv,6423906,Israel ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: