Novocure has enrolled the first patient in a trial to assess the use of its electric-stimulation technology in conjunction with standard therapies to treat lung cancer patients who failed to respond to platinum-based chemotherapy.
The Phase 3 trial will look at whether Novocure’s Tumor Treating Fields (TTFields) technology, in combination with immune checkpoint inhibitors or Taxol (docetaxel), can help those with non-small cell lung cancer (NSCLC).
“We designed this trial to test TTFields with two of the currently available standard of care treatments for advanced NSCLC following failure of platinum-based therapy, opening the trial to more patients with this disease,” Dr. Eilon Kirson, the chief science officer and head of research and development at Novocure, said in a news release.
“We are excited about the potential of TTFields for the treatment of advanced NSCLC, and we are pleased to start this pivotal trial,” he added.
TTFields are low-intensity alternating electric fields. They activate cells programmed to kill proliferating cancer cells by preventing the tumor cells from dividing properly.
The noninvasive treatment applies transducer arrays to the surface of the skin in the region surrounding the tumor. A transducer changes electrical energy to ultrasound energy.
The TTFields delivery system is portable, allowing patients to perform normal daily activities.
Preclinical studies have suggested that TTFields may work in conjunction with certain taxanes to improve the effectiveness of immune checkpoint inhibitors. A taxane is a therapy that inhibits the division of tumor cells by binding to and interfering with the action of cell components known as microtubules.
A Phase 2 pilot EF-15 trial (NCT00749346) tested TTFields in combination with Alimta (pemetrexed) as a non-first-line treatment in 42 NSCLC patients. The combination led to a progression-free survival rate of more than five months and an overall survival rate of 13.8 months. The two figures exceeded Alimta’s historical results as a second-line treatment.
Importantly, 17% of the trial participants had a tumor type that typically does not respond to Alimta.
Based on the findings, Novocure designed the Phase 3 LUNAR trial (NCT02973789) to assess the safety and effectiveness of TTFields in combination with standard of care treatment — either immune checkpoint inhibitors or Taxol — in patients with advanced NSCLC who failed platinum-based chemotherapy.
The randomized, controlled, international trial is expected to enroll 512 participants with stage 3B or 4 cancer. Some of the participants will receive standard of care alone, and others a combination of TTFields and standard of care.
The study’s primary endpoint, or measuring stick, will be overall survival of patients receiving both TTFields and another therapy. Secondary measures will include progression-free survival, radiological response rate, quality of life, and the severity and frequency of adverse events.
“The start of LUNAR, our second ongoing Phase 3 trial beyond glioblastoma, further demonstrates our commitment to testing TTFields across a variety of solid tumor cancers and bringing our therapy to patients who may benefit from it,” Novocure CEO Asaf Danziger said. “We believe that treatment with TTFields is bigger than one cancer type. We are developing a profoundly different approach to cancer therapy that has the potential to improve the lives of people affected by a range of solid tumor cancers.”