RecruitingPhase 3

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

AZ

CA

FL

IL

IN

KS

MO

NC

NY

PA

TX

WA