Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) (KEYNOTE B36)
|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: NCT04892472|
Recruitment Status : Recruiting
First Posted : May 19, 2021
Last Update Posted : June 3, 2022
This is a multicenter, single arm, open-label study of Tumor Treating Fields (TTFields) at 150 kHz to the thorax using the NovoTTF-200T System concomitant with IV pembrolizumab in subjects previously untreated for their advanced or metastatic intrathoracic, PD-L1 positive non-small cell lung cancer (NSCLC). The primary objective is to evaluate the objective response rate (ORR) by RECIST 1.1 in subjects with TPS ≥1 percent.
The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Device: NovoTTF-200T||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EF-36/Keynote B36: A Pilot, Single Arm, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Intrathoracic Non-small Cell Lung Cancer|
|Actual Study Start Date :||July 12, 2021|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||August 2024|
Experimental: Study Arm
Pembrolizumab and TTFields
All patients enrolled in the study will receive TTFields treatment, delivered for at least 18 hours a day on average using NovoTTF-200T together with pembrolizumab, a standard immunotherapy agent, which is delivered intravenously.
Other Name: Drug: Pembrolizumab
- Objective Response Rate (ORR) [ Time Frame: 24 months ]ORR will be measured from the date of enrollment to date of progression (in months) based on RECIST 1.1 criteria. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent as a Secondary Outcome
- Overall survival (OS) [ Time Frame: 24 months ]Survival will be measured from date of enrollment until date of death. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent
- Progression Free Survival (PFS) [ Time Frame: 24 months ]The analysis will be estimated proportions of patients who are progression-free based on the RECIST 1.1 criteria following the time of enrollment. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent
- Progression Free Survival at 6 months (PFS6) [ Time Frame: 6 months ]The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RECIST 1.1 criteria following the time of enrollment
- 1-year survival rates [ Time Frame: 12 months ]The analyses will be performed based on estimated proportions of patients who are alive at one year following enrollment
- Duration of response (DOR) [ Time Frame: 24 months ]The analysis will be defined as the time from response to progression/death (P/D) based on RECIST 1.1 criteria
- Disease control rate (DCR) [ Time Frame: 24 months ]Will be defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response (CR), partial response (PR), and stable disease (SD) by RECIST 1.1
- Safety and Tolerability: adverse events (AEs) [ Time Frame: 24 months ]Will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with TTFields concomitant with pembrolizumab, as well as their association with study treatments
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): NCT04892472
|Contact: Cabilia Pichardo, MD||+1 email@example.com|