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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
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
NovoCure Ltd. ( NovoCure GmbH )

Study Description
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Brief Summary:

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

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Arm
Pembrolizumab and TTFields
 Device: NovoTTF-200T
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed, newly diagnosed unresectable stage III or metastatic (M1a) intrathoracic NSCLC without EGFR sensitizing mutation or ALK translocation
  • Age ≥ 22 years
  • Have a PD-L1 positive (TPS≥1%) tumor by local laboratory assessment
  • Measurable disease by RECIST 1.1
  • ECOG performance status of 0 to 1
  • Have not received prior systemic treatments for NSCLC.
  • Life expectancy of at least 3 months
  • Able to operate the NovoTTF-200T system

Exclusion Criteria:

  • Has an extrathoracic metastasis (i.e. M component is M1b or M1c)
  • Has an EGFR sensitizing mutation and/ or ALK translocation
  • If Stage III, can be treated with curative intent with either surgical resection and/or chemoradiation
  • Has received prior systemic anti-cancer therapy or prior radiotherapy for NSCLC (palliative radiotherapy is allowed)
  • Being unable to operate the NovoTTF-200T device independently or with the help of a caregiver
  • Pregnancy or breastfeeding
  • Significant illnesses not associated with the primary disease
  • Implanted electronic devices (e.g. pacemaker) in the upper torso
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Cabilia Pichardo, MD +1 603-436-2809 clinicaltrials@novocure.com

Locations
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Sponsors and Collaborators
NovoCure GmbH
Merck Sharp & Dohme LLC
More Information
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Additional Information:

Publications of Results:

Other Publications:
Lee SX, Wong ET, Swanson KD. Mitosis Interference of Cancer Cells by NovoTTF-100A Causes Decreased Cellular Viability. Cancer Res. 2013;73; 709. http://cancerres.aacrjournals.org/content/73/8%7B_%7DSupplement/709.abstract.
Bomzon Z, Urman N, Wenger C, et al. Transducer array layout optimization for treating lung-based tumors with TTFields. J Clin Oncol. 2015;33(suppl; abstr e18503). http://meetinglibrary.asco.org/content/147908-156.

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Responsible Party: NovoCure GmbH
ClinicalTrials.gov Identifier: NCT04892472    
Other Study ID Numbers: EF- 36
KEYNOTE-B36 ( Other Identifier: Merck Sharp & Dohme Corp )
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by NovoCure Ltd. ( NovoCure GmbH ):
Non-small cell lung cancer
NSCLC
Advanced non-small cell lung cancer
Metastatic non-small cell lung cancer
Immunotherapy
PDL-1 positive
Treatment
 Minimal toxicity
TTFields
Tumor Treating Fields
Novocure
Pembrolizumab
Merck
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents