Table of Contents
- Trial overview
- Small cell lung cancer studies
- Other cancer studies
- What researchers measure
- Who may join these trials
- How to read the trial phases
Trial overview
The source data shows Siltuximab in several cancer trials, mostly as part of combination studies rather than as a stand-alone study drug.[1] These trials are mainly in small cell lung cancer, with a few studies in other advanced cancers such as metastatic prostate cancer and B-cell lymphoma.[1]
Most of the studies are Phase 2 or Phase 3 trials, and one study is a Phase 1/2 trial.[1] The main purpose is to compare how well the treatment works and to check safety in different patient groups.[1]
Small cell lung cancer studies
Several trials focus on small cell lung cancer, including relapsed or refractory disease, limited-stage disease, and extensive-stage disease.[1] “Relapsed” means the cancer came back after treatment, and “refractory” means it did not respond well to treatment.[1]
In NCT05060016, researchers are studying tarlatamab in people with relapsed or refractory small cell lung cancer, with outcomes including objective response and treatment-emergent adverse events.[1] The study also looks at serum concentrations of tarlatamab in part of the trial, which means the amount of drug in the blood is being measured.[1]
NCT06745323 is a Phase 2, open-label, randomized, multicenter study in people with small cell lung cancer, and it measures confirmed complete response and partial response.[2] “Open-label” means both the researchers and participants know which treatment is being given.[2] “Randomized” means participants are assigned by chance to different study groups.[2]
NCT06117774 studies tarlatamab after chemoradiotherapy in limited-stage small-cell lung cancer, which means treatment is given after chemotherapy and radiation.[5] The main outcomes are progression-free survival and overall survival.[5]
NCT05740566 compares tarlatamab with standard of care chemotherapy in relapsed small cell lung cancer, and the main endpoint is overall survival.[6] This trial is designed to see whether one treatment approach helps people live longer than the usual treatment.[6]
2024-520050-38-00 and NCT06211036 both study extensive-stage small cell lung cancer, which is a more advanced form of the disease where cancer has spread widely.[3][7] These studies compare tarlatamab-based combinations against other treatment approaches and measure overall survival, with one also measuring progression-free survival.[3][7]
Other cancer studies
NCT05220098 is a first-in-human Phase 1/2 study in people with unresectable locally advanced or metastatic cancer.[4] “First-in-human” means the treatment is being studied in people for the first time.[4] The trial focuses on safety, tolerability, dose-limiting toxicities, and finding the maximum tolerated dose and recommended Phase 2 dose.[4]
2023-504830-23-00 is a Phase 3 study in B-cell lymphoma, comparing epcoritamab with standard of care chemotherapy and measuring overall survival and progression-free survival.[8] The study uses Lugano criteria, which is a standard way to judge lymphoma response on scans and other tests.[8]
NCT06691984 and 2025-520555-89-00 are Phase 3 studies in metastatic castration-resistant prostate cancer, and both compare study treatment against investigator’s choice options.[9][10] Their main outcome is overall survival.[9][10]
What researchers measure
The trials measure different outcomes to show whether treatment is helping and whether it is safe.[1] Common measures include overall survival, progression-free survival, and objective response, which tells whether tumors shrink or disappear.[1]
Some studies also measure complete response and partial response, which are more detailed ways to describe tumor improvement.[2] Safety measures include treatment-emergent adverse events and dose-limiting toxicities, which help researchers see whether a treatment causes new health problems or too much side effect burden.[1][4]
In some trials, results are checked by blinded independent central review or an independent review committee, meaning outside experts review the data without knowing which treatment was used.[1][8] This helps make the results more fair and reliable.[1]
Who may join these trials
The target populations are people with cancer that is advanced, has spread, or has come back after treatment.[1] The trials include people with relapsed or refractory small cell lung cancer, limited-stage small-cell lung cancer, extensive-stage small cell lung cancer, unresectable locally advanced or metastatic cancer, B-cell lymphoma, and metastatic castration-resistant prostate cancer.[1]
Each study has its own entry rules, so not every person with the listed condition can join.[1] The study team uses those rules to decide who is eligible and to keep the trial group as similar as possible for fair comparison.[1]
How to read the trial phases
Phase 1/2 trials usually start by checking safety, side effects, and dose, then may also look for early signs that the treatment works.[4] This is why the first-in-human study focuses on dose-limiting toxicities and the recommended dose for later testing.[4]
Phase 2 trials are often used to see if the treatment shows enough benefit to keep studying it, while continuing to watch safety.[1] Phase 3 trials are larger and compare the study treatment with another treatment or placebo to see which option works better for patients.[3][5]
