734 Participants Needed

TTFields + Pembrolizumab + Chemotherapy for Lung Cancer

(LUNAR-2 Trial)

Recruiting at 109 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment combination for individuals with advanced non-small cell lung cancer that has metastasized. The study tests whether adding TTFields (an electrical field therapy delivered by a device) to pembrolizumab (an immune therapy) and chemotherapy can extend patient survival and delay cancer progression. Participants are divided into two groups: one receives all three treatments, while the other receives only pembrolizumab and chemotherapy. This trial targets those who have not yet undergone treatment for their metastatic lung cancer. As a Phase 3 trial, it represents the final step before FDA approval, providing patients an opportunity to access potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are expected to need other cancer treatments while in the study or if you are on certain immunosuppressive therapies.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the NovoTTF-200T device, which uses Tumor Treating Fields (TTFields), is generally easy for patients to handle. Studies have found that it does not typically cause side effects affecting the whole body, making it a promising addition to lung cancer treatments.

Pembrolizumab, a type of immune therapy, also has a good safety record. It has been used for various cancers and already has FDA approval for other conditions. Most people tolerate it well, although some may experience side effects like tiredness or a rash.

Platinum-based chemotherapy, another part of the treatment, is commonly used and well-studied. It is known to cause side effects like nausea or hair loss, but these can usually be managed with supportive care.

Overall, researchers have studied the combination of these treatments to ensure they are as safe as possible for patients with advanced lung cancer.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine innovative technology with established cancer therapies to tackle lung cancer. Unlike the standard treatment of pembrolizumab and platinum-based chemotherapy, one treatment arm includes Tumor Treating Fields (TTFields) using the NovoTTF-200T device. TTFields is a novel approach that uses electric fields to disrupt cancer cell division, potentially enhancing the effectiveness of existing therapies. By integrating TTFields with pembrolizumab and chemotherapy, researchers hope to improve outcomes for patients by targeting cancer cells through multiple mechanisms.

What evidence suggests that this trial's treatments could be effective for advanced non-small cell lung cancer?

Research has shown that adding TTFields therapy to pembrolizumab and platinum-based chemotherapy can improve treatment outcomes for non-small cell lung cancer. In this trial, participants in Arm 1 will receive TTFields using the NovoTTF-200T device alongside pembrolizumab and platinum-based chemotherapy. TTFields use electric fields to target cancer cells. One study found that patients lived longer when TTFields were added to pembrolizumab compared to using pembrolizumab alone. Another report noted that this combination extended patients' lives by an additional 1.67 years and improved their quality of life compared to using pembrolizumab without TTFields. Additionally, the LUNAR study found a significant improvement in overall survival when TTFields were included. Overall, this combination appears promising for extending life and improving outcomes in patients with advanced lung cancer. Participants in Arm 2 will receive pembrolizumab and platinum-based chemotherapy without TTFields.23467

Are You a Good Fit for This Trial?

This trial is for adults with advanced non-small cell lung cancer that has spread, who are in good physical condition (able to perform daily activities without significant limitations) and have not had previous systemic treatment for their metastatic disease. Women must not be pregnant or breastfeeding, and men must agree to use contraception.

Inclusion Criteria

I am fully active or can carry out light work.
I am 22 years old or older.
I am not pregnant or breastfeeding.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TTFields using the NovoTTF-200T device, pembrolizumab, and platinum-based chemotherapy

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 6 years

What Are the Treatments Tested in This Trial?

Interventions

  • NovoTTF-200T
  • Pembrolizumab
  • Platinum-based Chemotherapy
Trial Overview The LUNAR-2 study tests the combination of TTFields delivered by NovoTTF-200T device with pembrolizumab and platinum-based chemotherapy. It aims to see if this mix can improve survival times for patients compared to current treatments, focusing on different subtypes of lung cancer.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: NovoTTF-200T, Pembrolizumab, and Platinum-based ChemotherapyExperimental Treatment3 Interventions
Group II: Arm 2: Pembrolizumab and Platinum-based ChemotherapyActive Control2 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
🇪🇺
Approved in European Union as KEYTRUDA for:
🇬🇧
Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

NovoCure GmbH

Lead Sponsor

Trials
16
Recruited
3,700+

Published Research Related to This Trial

In a real-life study of 121 patients with advanced non-squamous non-small cell lung cancer, the combination of pembrolizumab and chemotherapy resulted in a median progression-free survival of 9 months and overall survival of 20.6 months, demonstrating its efficacy as a first-line treatment.
The treatment was generally well-tolerated, with manageable side effects; however, 17.5% of patients experienced grade 3-4 adverse events, and there were two treatment-related deaths, indicating the need for careful monitoring during therapy.
Pembrolizumab plus pemetrexed-carboplatin combination in first-line treatment of advanced non-squamous non-small cell lung cancer: a multicenter real-life study (CAP29).Renaud, E., Ricordel, C., Corre, R., et al.[2023]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.
While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma.Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

Citations

NCT02973789 | Effect of Tumor Treating Fields (TTFields) ...Alternating electric fields (tumor-treating fields therapy) can improve chemotherapy treatment efficacy in non-small cell lung cancer both in vitro and in vivo.
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39931252/
Estimating the Cost-Effectiveness of Tumor Treating Fields ...TTFields therapy plus an ICI had 1.67 additional life years and 1.21 additional QALYs compared to an ICI alone, with an ICER of $58,764 per QALY ...
LUNAR-2: Pivotal, randomized, open-label study of tumor ...A pivotal, global, randomized, trial investigating the efficacy and safety of TTFields concomitant with pembrolizumab (P) and platinum-based chemotherapy (C)
LUNAR - NSCLC Clinical TrialUpdate: The LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over ...
Novocure Announces Presentations on Tumor Treating ...A striking 82% of the 710 patients surveyed opted to use TTFields therapy and demonstrated sustained health-related quality of life, except for more itchy skin, ...
The pivotal Phase 3 METIS trial enrolled ...The trial met its primary endpoint, showing a statistically significant delay in time to first intracranial progression for patients who ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/41033612/
Tumor Treating Fields (TTFields) therapy after stereotactic ...Results: Patients (N=298) were followed for a median of 8.6 (0.07-85.2) months. TTFields significantly delayed TTIP (HR 0.72 [95% CI 0.53-0.98]; ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security