Who is eligible for clinical trial NCT06216301?

Participants must meet the protocol's inclusion criteria for Metastatic Non-small Cell Lung Cancer. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06216301 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-24

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC (NCT06216301)

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

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: NovoCure GmbH

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (19 items).

Location: Central Alabama Research — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

≥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.

Usually NOT eligible if any of the following apply:

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).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (98 Sites)

Showing the first 25 of 98 sites.

Central Alabama Research — Birmingham, Alabama
Western Regional Medical Center, LLC — Goodyear, Arizona
St. Jude Herritage Medical Group — Fullerton, California
Hoag Family Cancer Institute - Hoag Memorial Hospital — Newport Beach, California
Sutter Institute for Medical Research — Sacramento, California
Florida Cancer Affiliates - Ocala Oncology — Ocala, Florida
Moffitt Cancer Center — Tampa, Florida
Northwest Oncology & Hematology — Barrington, Illinois
Elmhurst Hospital Nancy Knowles Cancer Center — Elmhurst, Illinois
Edward Cancer Center — Naperville, Illinois
Cancer Treatment Centers of America (CTCA) — Zion, Illinois
Parkview Packnett Family Cancer Institute — Fort Wayne, Indiana
Franciscan Health Indianapolis — Indianapolis, Indiana
University of Kansas Cancer Center — Westwood, Kansas
Luminis Health Radiation Oncology - Anne Arundel Health System — Annapolis, Missouri
University of Kansas Cancer Center - North — Kansas City, Missouri
University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri
University of Kansas Cancer Center - Overland Park — Overland, Missouri
New York Cancer & Blood Specialists (NYCBS) — New Hyde Park, New York
New York Cancer & Blood Specialists (NYCBS) — New York, New York
University of Rochester Medical Center — Rochester, New York
New York Cancer & Blood Specialists (NYCBS) — Shirley, New York
New York Cancer & Blood Specialists (NYCBS) — The Bronx, New York
WakeMed Health & Hospitals — Cary, North Carolina
Abramson Cancer Center — Philadelphia, Pennsylvania

📞 Contact the Study Coordinator

Phone: (205) 949-1907

Email: lszymela@centralalabamaresearch.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗