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LUNAR-2: TTFields with Pembrolizumab + Chemotherapy for Metastatic NSCLC

This study, called LUNAR-2, is investigating a new approach for metastatic non-small cell lung cancer (NSCLC), which is lung cancer that has spread. It combines three treatments: NovoTTF-200T (a device that uses electric fields to disrupt cancer cells), pembrolizumab (an immunotherapy that helps your immune system fight cancer), and platinum-based chemotherapy (a standard cancer treatment). The study aims to see if this combination is more effective and safer than pembrolizumab and chemotherapy alone. To join, you must be at least 18 years old (or 22 in the USA) with stage 4 NSCLC. The main goals are to measure how long people live (overall survival) and how long they live without their cancer growing (progression-free survival). The study is currently recruiting participants.

Study design
This is a randomized, open-label study comparing the new treatment combination to standard treatment. It plans to enroll 734 participants globally.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 6 years to assess overall survival and progression-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06216301

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
NovoCure GmbH
~734 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:NovoTTF-200TPembrolizumabPlatinum based chemotherapy

At a glance

Recruiting sites
98 of 98 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over up to 6 years
+1 more outcome measured

Conditions

Metastatic Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

98 sites across 36 states
France8
Italy8
Texas6
Germany6
Spain6
New York5
Washington5
Illinois4

Who to contact

Lorie Szymela
[email protected]
205-949-1907
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥22 years of age in 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
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

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.

What this trial measures

  • Overall Survival (OS)up to 6 years

    To compare OS in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to OS of those treated with pembrolizumab and platinum-based chemotherapy alone (superiority analysis).

  • Progression Free Survival (PFS)up to 6 years

    To compare PFS per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to PFS of those treated with pembrolizumab and platinum-based chemotherapy alone (superiority analysis)