Clinical Trial 23565

• Overview

  Study Title:

  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

  Summary:

  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.

  Objective:

  To test the effectiveness and safety of TTFields, delivered using the NovoTTF-200T device, concomitant with pembrolizumab and platinumbased chemotherapy in subjects with metastatic non-small cell lung cancer (NSCLC)

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy

  Medications:

  Alimta (Pemetrexed); Nab-paclitaxel (Abraxane); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); Taxol (paclitaxel); carboplatin (); cisplatin (); paclitaxel ()

• Inclusion Criteria

  Inclusion Criteria:
  • 22 years of age or older
  • 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 participant with a female partner(s) of child-bearing potential, must agree to use an effective contraception
  • All participants must sign written informed consent.
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria:
  • 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 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 less than 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. Patients 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: Patients 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 untreated or symptomatic Central Nervous System (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they were treated before randomization and are clinically stable and without requirement of steroid treatment for at least 3 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. Patients 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.
  • Other criteria may apply

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