In short
Clinical trials are studying Gsk6097608 in people with certain advanced cancers. These trials look at safety and how well Gsk6097608 works in combination with other immunotherapy drugs in first-line treatment for non-small cell lung cancer and head and neck cancer.
Key points
- Clinical trials of Gsk6097608 are studying it in combination with other immunotherapy treatments. One Phase 2 trial is in previously untreated advanced or metastatic non-small cell lung cancer, and another Phase 2 trial is in PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma. The studies are authorised and are looking at both safety and early signs of benefit. In the lung cancer trial, the main focus is treatment-related side effects, including serious side effects and treatment changes caused by side effects. In the head and neck cancer trial, the main focus is confirmed tumor response, meaning whether the cancer shrinks in a lasting way.
Clinical trial overview
Gsk6097608 is being tested in interventional studies, which means researchers are giving study treatments and then measuring results.
Both available trials are Phase 2 studies, so they are mainly looking for early signs of benefit while also checking safety.
The studies are authorised and focus on advanced cancers in adults.
Previously untreated advanced or metastatic non-small cell lung cancer study
NCT05565378 is a Phase 2 platform study in participants with previously untreated, advanced or metastatic non-small cell lung cancer.
This study includes Gsk6097608 with other immunotherapy drugs and is designed to monitor the safety of novel combinations.
The planned enrollment is 340 participants.
The main safety endpoint is the incidence of TEAEs and SAEs, which means how often treatment-related side effects and serious side effects happen.
The study also measures side effects that lead to dose changes, dose delays, or stopping study treatment.
PD-L1 positive recurrent or metastatic head and neck cancer study
Trial 2023-503428-24-00 is a Phase 2 platform study in participants with PD-L1 positive recurrent or metastatic squamous cell carcinoma of the head and neck.
This study is testing Gsk6097608 in first-line treatment, meaning it is being studied as an initial treatment option for this cancer group.
The planned enrollment is 360 participants.
The brief summary says the study aims to evaluate the antitumor activity of novel immunotherapy combinations compared with dostarlimab in participants with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.
What the trials measure
The lung cancer study measures safety as its primary outcome.
Its main endpoint is the number of treatment-emergent adverse events and serious adverse events, plus events that cause dose modification or treatment discontinuation.
The head and neck cancer study measures confirmed objective response rate, or ORR, as its primary outcome.
Confirmed ORR means the percentage of participants who have a confirmed complete response or partial response based on RECIST 1.1, a standard way to measure tumor shrinkage.
Who can join these studies
These trials are for adults with specific advanced cancers, not for all cancer types.
The lung cancer study is for people who have previously untreated advanced or metastatic non-small cell lung cancer.
The head and neck study is for people with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.
Because the studies are platform trials, they are built to test treatment combinations within a larger research plan.
Key terms for patients
- Authorised means the study has been approved to move forward in the listed setting.
- Metastatic means the cancer has spread to other parts of the body.
- Recurrent means the cancer has come back after treatment.
- First-line treatment means the first treatment given for the cancer.
- Complete response means no signs of cancer are seen on testing.
- Partial response means the cancer has shrunk, but not disappeared completely.