Trial Title:
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
NCT ID:
NCT06216301
Condition:
Metastatic Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Conditions: Keywords:
NSCLC
Metastatic
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
NovoTTF-200T
Description:
The NovoTTF-200T is a portable, battery operated system intended for continuous home use,
which delivers TTFields at a frequency of 150kHz to the subject by means of insulated
transducer arrays. TTFields physically disrupt the rapid cell division exhibited by
cancer cells. The physical disruption induced by TTFields can lead to to downstream
immunogenic cell death.
Drug: Pembrolizumab. Pembrolizumab is an immune checkpoint inhibitor that helps the
immune system recognize and attack cancer cells.
Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the
treatment of non-small cell lung cancer.
Arm group label:
Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab is an immune checkpoint inhibitor that helps the immune system recognize
and attack cancer cells.
Arm group label:
Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy
Arm group label:
Arm 2: Pembrolizumab and Platinum-based Chemotherapy
Intervention type:
Drug
Intervention name:
Platinum based chemotherapy
Description:
Platinum-based chemotherapy is a standard chemotherapy regimen commonly used in the
treatment of non-small cell lung cancer
Arm group label:
Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based Chemotherapy
Arm group label:
Arm 2: Pembrolizumab and Platinum-based Chemotherapy
Summary:
This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using
TTFields, delivered by the NovoTTF-200T device, concomitantly administered with
pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell
lung cancer that has spread to other parts of the body. The primary goals of the study
are to assess overall survival and progression-free survival. Secondary objectives
include analyzing outcomes based on the specific histology (subtype) of the lung cancer.
Detailed description:
LUNAR-2 is a pivotal, randomized, open-label study that aims to evaluate the
effectiveness and safety of Tumor Treating Fields (TTFields) concomitantly administered
with pembrolizumab and platinum-based chemotherapy for the treatment of metastatic
non-small cell lung cancer (NSCLC).
The primary objectives of the study are to assess overall survival (OS) and
progression-free survival (PFS) in subjects treated with TTFields, pembrolizumab, and
platinum-based chemotherapy compared to those treated with pembrolizumab and
platinum-based chemotherapy alone. PFS will be evaluated by Response Evaluation Criteria
in Solid Tumors (RECIST) v1.1.
The secondary endpoints of this study will evaluate PFS and OS, stratified by the
specific histological subtype of NSCLC and PD-L1 Tumor Proportion Score (TPS).
The population will consist of subjects with an Eastern Cooperative Oncology Group (ECOG)
performance status of 0-1 and will be stratified as follow:
1. Histology - Squamous vs. non-squamous
2. PD-L1 expression level - TPS <1% vs. TPS 1-49% vs. TPS ≥50%
3. Prior treatment with immunotherapy - yes vs. no
The study will be conducted globally at approximately 130 participating sites. The study
device, NovoTTF-200T, is a portable, battery-operated system that delivers TTFields at a
frequency of 150kHz. It utilizes insulated transducer arrays to deliver electric forces
intended to disrupt cancer cell division.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- ≥22 years of age in the USA
≥18 years of age outside of the USA.
- Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the
American Joint Committee on Cancer [AJCC] criteria) non-squamous or squamous NSCLC.
- Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1.
- Have not received prior systemic treatment for their metastatic NSCLC. Subjects who
received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative
intent for non-metastatic disease are eligible if the therapy was completed at least
12 months prior to the development of metastatic disease.
- ECOG Performance Status (PS) of 0-1.
- Adequate hematologic and end-organ function
o For subjects not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN
(unless participant is receiving anticoagulant therapy as long as INR or aPTT is
within therapeutic range of intended use of anticoagulants).
- A female participant is eligible to participate if she is not pregnant, not
breastfeeding
- If male subject with a female partner(s) of child-bearing potential, must agree to
use an effective contraception
- All subjects must sign written informed consent.
Exclusion Criteria:
All individuals meeting any of the following exclusion criteria will be excluded from
study participation:
- Mixed small cell and NSCLC histology.
- EGFR sensitizing mutation and/or ALK translocation, and/or ROS1 and/or RET
targetable gene rearrangement, and/or METex14 skipping mutation, and/or NTRK1/2 gene
fusion directed therapy is indicated or planned for other targeted therapy, where
such testing and therapy is locally approved and available.
- Has received systemic therapy for metastatic disease.
- Had major surgery <3 weeks prior to randomization
- Received radiation therapy to the lung that is > 30 Gy within 6 months of
randomization.
- Has received prior radiotherapy within 2 weeks of randomization. Subjects must have
recovered from all radiation-related toxicities, not require corticosteroids, and
not have had radiation pneumonitis. A 1-week washout is permitted for palliative
radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Is expected to require any other form of antineoplastic therapy while on study.
- Has a known additional malignancy that is progressing or has required active
treatment within the past 3 years.
- Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma
of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in
situ) that have undergone potentially curative therapy are not excluded
- Has untreated or symptomatic Central Nervous System (CNS) metastases and/or
carcinomatous meningitis. Subjects with previously treated brain metastases may
participate provided they were treated before randomization and are clinically
stable and without requirement of steroid treatment for at least 3 days prior to
randomization.
- Has active autoimmune disease that has required systemic treatment in past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs).
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior randomization. Subjects with asthma
that require intermittent use of bronchodilators, inhaled steroids, or local steroid
injections would not be excluded from the study.
- Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody
or a small molecule targeting other immuno-regulatory receptors or mechanisms in the
12 months prior to randomization.
- Participation in another clinical study with an investigational agent or device
during the 4 weeks prior to randomization.
- Concurrent treatment with other experimental treatments for NSCLC while in the
study.
- Has a known sensitivity to any component of the planned systemic therapies
(pembrolizumab, cisplatin/carboplatin, pemetrexed/paclitaxel/nab-paclitaxel) .
- Pregnant or breastfeeding
- Admitted to an institution by administrative or court order.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
BRCR Global
Address:
City:
Plantation
Zip:
33324
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yerli Madriz
Phone:
561-447-0614
Phone ext:
102
Email:
ymadriz@brcrglobal.com
Contact backup:
Last name:
Barbara Hilewsky
Phone:
1-561-447-0614
Email:
brauliov@brcrglobal.com
Investigator:
Last name:
Jason Tache
Email:
Principal Investigator
Facility:
Name:
Cancer Treatment Centers of America (CTCA)
Address:
City:
Zion
Zip:
60099
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sylvia Schneiderman
Phone:
847-746-6983
Email:
sylvia.schneiderman@coh.org
Contact backup:
Last name:
Evan Pisick
Phone:
1-847-731-1648
Email:
RAP@ctca-hope.com
Investigator:
Last name:
Laura Farrington
Email:
Principal Investigator
Facility:
Name:
Franciscan Health Indianapolis
Address:
City:
Indianapolis
Zip:
46237
Country:
United States
Status:
Recruiting
Contact:
Last name:
Olivia Martin
Phone:
317-528-7822
Email:
oliva.martin@franciscanalliance.org
Contact backup:
Last name:
Sameer Ahmed
Phone:
317-859-5252
Email:
sameer.ahmed@franciscanalliance.org
Investigator:
Last name:
Michael Eaton
Email:
Principal Investigator
Start date:
July 31, 2024
Completion date:
October 2028
Lead sponsor:
Agency:
NovoCure GmbH
Agency class:
Industry
Source:
NovoCure Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06216301
