Trial results for the Phase 2 study investigating TG4010 and nivolumab in patients with lung cancer were posted on ClinicalTrials.gov on 2025-11-10. The study, NCT02823990, evaluated the combination therapy in non-small cell lung cancer. Key findings included an objective response rate of 0.083 and a median overall survival of 220 days.
Background
The study investigated the combination of TG4010 and nivolumab in patients with non-small cell lung cancer. Nivolumab is a monoclonal antibody that interferes with the ability of tumor cells to grow and spread. TG4010 is described as a vaccine made from a gene-modified virus, intended to help the body build an effective immune response to kill tumor cells.
Trial design
The Phase 2 trial (NCT02823990) was titled "TG4010 and Nivolumab in Patients With Lung Cancer" and completed with an enrollment of 13 participants. The study focused on patients with recurrent non-small cell lung carcinoma, as well as those with Stage I, Stage II, Stage IIIA, and Stage IIIB non-small cell lung cancer. The trial evaluated the combination of TG4010 and nivolumab.
Key results
Results for the combination of TG4010 and nivolumab were reported for the treatment group. For the outcome of "ORR Defined as the Proportion of Patients Whose Best Overall Response (BOR) is Either Complete Response (CR) or Partial Response (PR) According to RECIST 1.1", the proportion of evaluable participants was 0.083. The "Disease Control Rate (DCR) Defined as the Proportion of Patients Whose Best Overal Response is Either CR, PR or SD, Assessed by RECIST 1.1" was 0.25. The "Stable Disease (SD) Rate Defined as the Proportion of Patients Whose Best Overall Response (BOR) is SD, Assessed by RECIST 1.1" was 0.17.
The mean "Duration of Response (DOR) Defined as Patients Whose Best Overall Response is CR or PR (Confirmed Response)" was 4 years. Median "Overall Survival (OS)" was 220 days, and median "Progression Free Survival (PFS) Defined by RECIST 1.1" was 41 days. Regarding safety, the "Number of Participants With Adverse Events Reported Per CTCAE v4.0" was 13 participants.
What this means
The results from this Phase 2 trial provide initial data on the efficacy and safety of combining TG4010 with nivolumab in patients with non-small cell lung cancer. The observed objective response rate of 0.083 and disease control rate of 0.25 suggest limited clinical activity in this small patient population. The median overall survival of 220 days and median progression-free survival of 41 days indicate that further investigation may be needed to determine the optimal role of this combination therapy in lung cancer treatment. All 13 participants experienced adverse events, which is consistent with the nature of cancer therapies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02823990, titled "TG4010 and Nivolumab in Patients With Lung Cancer," were posted on 2025-11-10 on clinicaltrials.gov.