LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
LUNAR-2 tests the safety and effects of TTFields treatment from the NovoTTF-200T device, given with pembrolizumab and platinum-based chemotherapy. It is for adults with non-small cell lung cancer that has spread to other parts of the body. The study looks at how long people live and how long they live without their cancer getting worse.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 22 or older in the U.S., or age 18 or older outside the U.S.
- Have stage 4 non-small cell lung cancer confirmed by a tissue or cell test.
- Have cancer in the chest that the study team can assess.
- Have had no whole-body drug treatment for cancer that has spread. Earlier treatment aimed at curing cancer before it spread is allowed if it ended at least 12 months before the cancer spread.
- Be fully active or able to do light work despite some limits on hard physical activity.
- Have blood counts, blood clotting tests, and organ function that meet study requirements.
- Not be pregnant or breastfeeding. Men with partners who could become pregnant must agree to use effective birth control.
- Sign a written form agreeing to take part.
Who can't join
- Have a mix of small cell and non-small cell lung cancer, or certain cancer gene changes for which targeted treatment is indicated or planned and locally approved and available.
- Have already had whole-body drug treatment for cancer that has spread, or be expected to need other cancer treatment during the study.
- Have had major surgery within 3 weeks, lung radiation over 30 Gy within 6 months, or other radiation within 2 weeks before study group assignment. Some short courses of radiation to ease symptoms allow a 1-week gap. Radiation side effects must have cleared, with no need for steroids and no past radiation-related lung swelling.
- Have another cancer that is growing or needed treatment in the past 3 years. Some treated skin cancers and cancers that have not spread beyond their starting layer are allowed.
- Have cancer spread to the brain or spinal cord that causes symptoms, or to their lining. Spread without symptoms or previously treated brain tumors may be allowed if stable and no steroids are needed for at least 7 days.
- Have an illness in which the immune system attacks the body that needed whole-body treatment in the past 2 years, a weakened immune system, or recent use of certain medicines that suppress it. Some asthma treatments are allowed.
- Have used certain immune-based cancer treatments in the past 12 months, joined a study of an experimental drug or device within 4 weeks, or be receiving another experimental lung cancer treatment.
- Have a known sensitivity to any planned study drug, be pregnant or breastfeeding, or have been placed in an institution by a court or government order.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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.
Study sites (38)
AL
- Central Alabama Research · Birmingham, AL 35209Lorie Szymela · Study contact · 205-949-1907 · lszymela@centralalabamaresearch.comMore trials in Birmingham
AZ
- Western Regional Medical Center, LLC · Goodyear, AZ 85338Janiece Denaro · Study contact · 1- 623-207-3196 · Janiece.Denaro@ctca-hope.comMore trials in Goodyear
CA
- St. Jude Herritage Medical Group · Fullerton, CA 92835Larissa Ulloa · Study contact · 800-627-8106 · larissa.lacson@providence.orgMore trials in Fullerton
- Hoag Family Cancer Institute - Hoag Memorial Hospital · Newport Beach, CA 92663Patrice Jones · Study contact · 949-764-5501 · Patrice.Jones@hoag.orgMore trials in Newport Beach
- Sutter Institute for Medical Research · Sacramento, CA 95816Clara Dunn · Study contact · 1-916-454-6931 · Clara.Dunn@sutterhealth.orgMore trials in Sacramento
FL
- Baptist MD Anderson Cancer Center, Baptist Health · Jacksonville, FL 32207Vanessa Tolsa · Study contact · 305-915-6496 · vanessa.tolsa@bmcjax.comJohn Vu · Principal investigatorMore trials in Jacksonville
- Florida Cancer Affiliates - Ocala Oncology · Ocala, FL 34474Megan Cerrato · Study contact · 352-547-1943 · Megan.Cerrato@usoncology.comMore trials in Ocala
- Moffitt Cancer Center · Tampa, FL 33612Maya Douglas · Study contact · 813-745-0969 · maya.douglas@moffitt.orgMore trials in Tampa
IL
- Northwest Oncology & Hematology · Barrington, IL 60010Khalada Admad · Study contact · 224-273-8971 · khalada.ahmad@ascension.orgMore trials in Barrington
- Elmhurst Hospital Nancy Knowles Cancer Center · Elmhurst, IL 60126Jessica Schnase · Study contact · 630-646-6029 · Jessica.Schnase@EEHealth.orgMore trials in Elmhurst
- Edward Cancer Center · Naperville, IL 60540-6766Jessica Schnase · Study contact · 630-646-6029 · Jessica.Schnase@EEHealth.orgMore trials in Naperville
- Cancer Treatment Centers of America (CTCA) · Zion, IL 60099Sylvia Schneiderman · Study contact · 1-847-746-6983 · sylvia.schneiderman@coh.orgMore trials in Zion
IN
- Parkview Packnett Family Cancer Institute · Fort Wayne, IN 46845Brian Chang, Dr. · Study contact · 1-833-724-8326 · brian2.chang@parkview.comBrian Chang · Principal investigatorMore trials in Fort Wayne
- Franciscan Health Indianapolis · Indianapolis, IN 46237Olivia Martin · Study contact · 317-528-7822 · Olivia.martin@franciscanalliance.orgMore trials in Indianapolis
KS
- University of Kansas Cancer Center · Westwood, KS 66205KUCC Navigation · Study contact · 913-588-3671 · kucc_navigation@kumc.eduMore trials in Westwood
MO
- Luminis Health Radiation Oncology - Anne Arundel Health System · Annapolis, MO 21401Rachael Niedelman · Study contact · 443 659 8685 ext. 802 · rniedelman@velocityclinical.comMore trials in Annapolis
- University of Kansas Cancer Center - North · Kansas City, MO 64154KUCC Navigation · Study contact · 913-588-3671 · kucc_navigation@kumc.eduMore trials in Kansas City
- University of Kansas Cancer Center - Lee's Summit · Lee's Summit, MO 64064KUCC Navigation · Study contact · 913-588-3671 · kucc_navigation@kumc.eduMore trials in Lee's Summit
- University of Kansas Cancer Center - Overland Park · Overland, MO 66210KUCC Navigation · Study contact · 913-588-3671 · kucc_navigation@kumc.eduMore trials in Overland
NC
- WakeMed Health & Hospitals · Cary, NC 27518Taylor Childress · Study contact · 919-350-1700 ext. 14842 · tchildress@wakemed.orgMore trials in Cary
NY
- New York Cancer & Blood Specialists (NYCBS) · New Hyde Park, NY 11042Laura Parisi · Study contact · 631-675-5146 · lparisi@nycancer.comMore trials in New Hyde Park
- New York Cancer & Blood Specialists (NYCBS) · New York, NY 10028Laura Parisi · Study contact · 631-675-5146 · lparisi@nycancer.comMore trials in New York
- University of Rochester Medical Center · Rochester, NY 14642Sierra Napoli · Study contact · 585-276-0648 · Sierra_Napoli@URMC.Rochester.eduMore trials in Rochester
- New York Cancer & Blood Specialists (NYCBS) · Shirley, NY 19967Laura Parisi · Study contact · 631-675-5146 · lparisi@nycancer.comMore trials in Shirley
- New York Cancer & Blood Specialists (NYCBS) · The Bronx, NY 10469Laura Parisi · Study contact · 631-675-5146 · lparisi@nycancer.comMore trials in The Bronx
PA
- Abramson Cancer Center · Philadelphia, PA 19104Ryan Roddy · Study contact · 267-408-3199 · ryan.roddy@pennmedicine.upenn.eduMore trials in Philadelphia
- AHN Cancer Center · Pittsburgh, PA 15212Ariel Lopez-Chavez · Study contact · 412-518-5025 · clinicaltrials@ahn.orgMore trials in Pittsburgh
TX
- Old Parkland Hospital Hematology Oncology Clinic · Dallas, TX 75235Ebele Mbanugo · Study contact · 214-645-0326 · ebele.mbanugo@utsouthwestern.eduMore trials in Dallas
- UT Southwestern Medical Center · Dallas, TX 75235Ebele Mbanugo · Study contact · 214-645-0326 · ebele.mbanugo@utsouthwestern.eduMore trials in Dallas
- DHR Health Oncology Institute · Edinburg, TX 78539Edgar Lopez · Study contact · 956-362-2394 · ed.lopez@dhr-rgv.comMore trials in Edinburg
- Houston Methodist Cancer Center · Houston, TX 77030Nicole Barrios · Study contact · 713-441-5607 · nkbarrios@houstonmethodist.orgJun Zhang · Principal investigatorMore trials in Houston
- Methodist Richardson Cancer Center · Richardson, TX 75082Crystee Cooper · Study contact · 214-947-1280 · ClinicalResearch@mhd.comMore trials in Richardson
- Jason Bates at University of Texas Health Science Center · San Antonio, TX 78229Epp Goodwin · Study contact · 210-450-5798 · goodwine@uthscsa.eduMore trials in San Antonio
WA
- MultiCare Regional Cancer Center · Auburn, WA 98001Stacey Macon · Study contact · 1-253-403-0791 · Stacey.macon@multicare.orgMore trials in Auburn
- MultiCare Regional Cancer Center · Gig Harbor, WA 98335Stacey Macon · Study contact · 1-253-403-0791 · Stacey.macon@multicare.orgMore trials in Gig Harbor
- MultiCare Regional Cancer Center · Puyallup, WA 98372Stacey Macon · Study contact · 1-253-403-0791 · Stacey.macon@multicare.orgMore trials in Puyallup
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown · Spokane, WA 99218Rachel Smith · Study contact · 1-509-838-2531 · rachel.smith@multicare.orgMore trials in Spokane
- MultiCare Institute for Research & Innovation · Tacoma, WA 98405Stacey Macon · Study contact · 1-253-403-0791 · Stacey.macon@multicare.orgMore trials in Tacoma