LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
Recruiting · NCT06216301 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
- 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 and/or BRAF V600 mutations 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 symptomatic Central Nervous System (CNS) metastases and/or carcinomatous meningitis. Subjects with asymptomatic CNS metastases or with previously treated brain metastases may participate provided they were treated before randomization (if applicable) and are neurologically stable and without requirement of steroid treatment for at least 7 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.
Where it is running
60 locations listed across 13 US states.
- Central Alabama Research - Birmingham, Alabama, United States
- Western Regional Medical Center, LLC - Goodyear, Arizona, United States
- St. Jude Herritage Medical Group - Fullerton, California, United States
- Hoag Family Cancer Institute - Hoag Memorial Hospital - Newport Beach, California, United States
- Sutter Institute for Medical Research - Sacramento, California, United States
- Florida Cancer Affiliates - Ocala Oncology - Ocala, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Northwest Oncology & Hematology - Barrington, Illinois, United States
- Elmhurst Hospital Nancy Knowles Cancer Center - Elmhurst, Illinois, United States
- Edward Cancer Center - Naperville, Illinois, United States
- Cancer Treatment Centers of America (CTCA) - Zion, Illinois, United States
- Parkview Packnett Family Cancer Institute - Fort Wayne, Indiana, United States
- Franciscan Health Indianapolis - Indianapolis, Indiana, United States
- University of Kansas Cancer Center - Westwood, Kansas, United States
- Luminis Health Radiation Oncology - Anne Arundel Health System - Annapolis, Missouri, United States
- University of Kansas Cancer Center - North - Kansas City, Missouri, United States
- University of Kansas Cancer Center - Lee's Summit - Lee's Summit, Missouri, United States
- University of Kansas Cancer Center - Overland Park - Overland, Missouri, United States
- New York Cancer & Blood Specialists (NYCBS) - New Hyde Park, New York, United States
- New York Cancer & Blood Specialists (NYCBS) - New York, New York, United States
- University of Rochester Medical Center - Rochester, New York, United States
- New York Cancer & Blood Specialists (NYCBS) - Shirley, New York, United States
- New York Cancer & Blood Specialists (NYCBS) - The Bronx, New York, United States
- WakeMed Health & Hospitals - Cary, North Carolina, United States
- Abramson Cancer Center - Philadelphia, Pennsylvania, United States
- AHN Cancer Center - Pittsburgh, Pennsylvania, United States
- Old Parkland Hospital Hematology Oncology Clinic - Dallas, Texas, United States
- UT Southwestern Medical Center - Dallas, Texas, United States
- DHR Health Oncology Institute - Edinburg, Texas, United States
- Houston Methodist Cancer Center - Houston, Texas, United States
- Methodist Richardson Cancer Center - Richardson, Texas, United States
- Jason Bates at University of Texas Health Science Center - San Antonio, Texas, United States
- MultiCare Regional Cancer Center - Auburn, Washington, United States
- MultiCare Regional Cancer Center - Gig Harbor, Washington, United States
- MultiCare Regional Cancer Center - Puyallup, Washington, United States
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown - Spokane, Washington, United States
- MultiCare Institute for Research & Innovation - Tacoma, Washington, United States
- Emek Medical Center - Afula, Israel
- A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria - Alessandria, Italy
- Rijnstate Ziekenhuis - Arnhem, Netherlands
- Cantonal Hospital Baden - Baden, Switzerland
- Institut Catala d'Oncologia - Barcelona, Spain
- Humanitas Gavazzeni - Bergamo, Italy
- Evangelische Lungenklinik Berlin - Berlin, Germany
- Cliniques universitaires Saint-Luc - Brussels, Belgium
- Centre Hospitalier Intercommunal de Creteil - Créteil, France
- Farkasgyepui Tudogyogyintezet - Farkasgyepű, Hungary
- Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ferrara, Italy
- HFR Freiburg-Kantonsspital - Fribourg, Switzerland
- Medisch Centrum Leeuwarden (MCL) - Oncologisch Centrum Leeuwarden (OCL) - Friesland, Netherlands
- AZ Maria Middelares - Campus Maria Middelares - Ghent, Belgium
- University Hospital Giessen, ZIM IV - Giessen, Germany
- Bnai zion MC - Haifa, Israel
- Krankenhaus Martha-Maria Halle-Dolau - Halle, Germany
- St. Jansdal ziekenhuis - Harderwijk, Netherlands
- Thoraxklinik Heidelberg - Heidelberg, Germany
- Universitaetsklinik fuer Innere Medizin V Innsbruck - Innsbruck, Austria
- Bacs-Kiskun Varmegyei Oktatokorhaz - Kecskemét, Hungary
- CHU Limoges - Limoges, France
- Hospital Universitario Arnau de Vilanova - Lleida, Spain
Showing 60 of 98 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →