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)
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|ClinicalTrials.gov Identifier: NCT03353675|
Recruitment Status : Completed
First Posted : November 27, 2017
Results First Posted : January 11, 2022
Last Update Posted : January 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer Metastatic||Biological: TG4010 Drug: Chemotherapy Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||January 5, 2018|
|Actual Primary Completion Date :||November 20, 2019|
|Actual Study Completion Date :||February 17, 2021|
1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks
Pemetrexed/Cisplatin or Carboplatin
360 mg IV administration every 3 weeks
- Objective Response Rate (ORR) [ Time Frame: 15 months ]
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.
- Progression Free Survival (PFS) [ Time Frame: 28 months ]
Time from the date of the first study drug administration to the date of first documented tumor progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
The Kaplan-Meier estimator was used to estimate median PFS and its confidence interval.
- Disease Control Rate (DCR) [ Time Frame: 15 months ]Percentage of participants whose best overall response is either complete response, partial response or stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and no measurable non-target lesions; Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD).
- Overall Survival [ Time Frame: 28 months ]
Overall Survival (OS) is defined as the time from the first study drug administration to the date of death due to any cause.
The Kaplan-Meier estimator was used to estimate median OS and its confidence interval.
- Duration of Overall Response (DoR) [ Time Frame: 28 months ]Time from first documented response (complete response or partial response) until documented disease progression or death due to lung cancer.
- Number of Participants With Adverse Events or Abnormalities [ Time Frame: 28 months ]The assessment of safety of the combination was based mainly on the frequency of adverse events, serious adverse events, adverse events of special interest (Injection site reaction, fatigue, pyrexia, infusion-related reactions and diarrhea), immune-mediated adverse events and laboratories abnormalities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353675
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28204|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|