A 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)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03353675|
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|NSCLC||Biological: TG4010 Drug: Chemotherapy Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 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 16, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
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 ]Proportion of patients whose best overall response is CR or PR using RECIST 1.1
- Progression Free Survival (PFS) [ Time Frame: 15 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.
- Disease Control Rate (DCR) [ Time Frame: 15 months ]Proportion of patients whose best overall response is either CR, PR, or SD.
- Overall Survival (OS) [ Time Frame: 27 months ]Time from the date of first study treatment administration to the date of death due to any cause.
- Duration of overall Response (DoR) [ Time Frame: 15 months ]Time from first documented response (CR or PR) until documented disease progression or death due to lung cancer.
- Evaluation of Safety profile [ Time Frame: Up to 100 days after last study treatment administration ]Incidence of all AEs, SAEs according to CTCAE v4.03.
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
|Contact: Transgene EU, Clinical Operations Department||+ 33 (0) 3 88 27 91 firstname.lastname@example.org|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28204|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|