NCT06216301 | RECRUITING | Metastatic Non-small Cell Lung Cancer

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

Sponsor:

Novocure GMBH

Brief 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.

Condition or disease

Metastatic Non-small Cell Lung Cancer

Intervention/treatment

NovoTTF-200T

Pembrolizumab

Platinum based chemotherapy

Phase

PHASE3

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.

Study Type :	INTERVENTIONAL
Estimated Enrollment :	734 participants
Masking :	NONE
Primary Purpose :	TREATMENT
Official Title :	LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date :	2024-07-31
Estimated Primary Completion Date :	2028-10
Estimated Study Completion Date :	2028-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:	18 Years
Sexes Eligible for Study:	ALL
Accepts Healthy Volunteers:

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.

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

Location Details

NCT06216301

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Locations

RECRUITING

United States, Albama

Central Alabama Research

Birmingham, Albama, United States, 35209

RECRUITING

United States, Arizona

Western Regional Medical Center, LLC

Goodyear, Arizona, United States, 85338

RECRUITING

United States, California

St. Jude Herritage Medical Group

Fullerton, California, United States, 92835

RECRUITING

United States, California

Hoag Family Cancer Institute - Hoag Memorial Hospital

Newport Beach, California, United States, 92663

RECRUITING

United States, California

Sutter Institute for Medical Research

Sacramento, California, United States, 95816

RECRUITING

United States, Florida

Florida Cancer Affiliates - Ocala Oncology

Ocala, Florida, United States, 34474

RECRUITING

United States, Florida

BRCR Global

Plantation, Florida, United States, 33324

RECRUITING

United States, Illinois

Northwest Oncology & Hematology

Barrington, Illinois, United States, 60010

RECRUITING

United States, Illinois

Elmhurst Hospital Nancy Knowles Cancer Center

Elmhurst, Illinois, United States, 60126

RECRUITING

United States, Illinois

Edward Cancer Center

Naperville, Illinois, United States, 60540-6766

RECRUITING

United States, Illinois

Edward Cancer Center-Plainfield

Plainfield, Illinois, United States, 60585

RECRUITING

United States, Illinois

Cancer Treatment Centers of America (CTCA)

Zion, Illinois, United States, 60099

RECRUITING

United States, Indiana

Franciscan Health Indianapolis

Indianapolis, Indiana, United States, 46237

RECRUITING

United States, Kansas

University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

RECRUITING

United States, Missouri

University of Kansas Cancer Center - North

Kansas City, Missouri, United States, 64154

RECRUITING

United States, Missouri

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States, 64064

RECRUITING

United States, Missouri

University of Kansas Cancer Center - Overland Park

Overland, Missouri, United States, 66210

RECRUITING