Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03353675 | A Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With the Therapeutic Vaccine Named TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC) | PHASE2 | COMPLETED | 44 | — | — | Jan 5, 2018 | Feb 17, 2021 | Jan 11, 2022 | 9 | United States, Belgium +2 |
Percentage of participants whose best overall response is complete response or partial response using RECIST 1.1. confirmed by a second scan no less than 4 weeks after the criteria for response are first met. Complete response: disappearance of all lesions and no new lesions. Partial response: decrease of at least 30% in the sum of the diameters of measurable lesions taking as reference the baseline sum of diameters, no progression of non-measurable lesions and no new lesions.
| Arm | Type | Description |
|---|---|---|
| TG4010/Chemotherapy/Nivolumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TG4010 | BIOLOGICAL | 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks |
| Chemotherapy | DRUG | Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance |
| Nivolumab | DRUG | 360 mg IV administration every 3 weeks |
Principal Inclusion Criteria: * Female or male patients age \> 18 years-old * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at study entry * Life expectancy of at least 3 months * Histologically confirmed non-squamous NSCLC (adenocarcinoma, large cell carcinoma, undiffere...