TTFields + Pembrolizumab + Chemotherapy for Lung Cancer
(LUNAR-2 Trial)
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.12345Why 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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TTFields using the NovoTTF-200T device, pembrolizumab, and platinum-based chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NovoTTF-200T
- Pembrolizumab
- Platinum-based Chemotherapy
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
NovoCure GmbH
Lead Sponsor