A Phase 3 trial is recruiting 450 participants at clinics worldwide to test whether nintedanib, used in combination with the standard chemotherapy drugs Alimta (pemetrexed) and Platinol (cisplatin) in patients with a certain type of lung cancer, achieves better results compared to chemotherapy alone.
The study, initiated by Boehringer Ingelheim, is exploring the use of nintedanbi in treating patients with unresectable pleural mesothelioma of the epithelioid type. The Phase 3 trial aims to confirm Phase 2 data that showed patients treated with the combination therapy lived 64 percent longer without their cancer progressing, compared to those treated with chemotherapy alone.
Boehringer Ingelheim researchers, along with their collaborators at clinical centers, described the design and rationale for the trial in the article, “LUME-Meso: Design and Rationale of the Phase III Part of a Placebo-Controlled Study of Nintedanib and Pemetrexed/Cisplatin Followed by Maintenance Nintedanib in Patients with Unresectable Malignant Pleural Mesothelioma,” published in the journal Clinical Lung Cancer.
The trial, called LUME-Meso (NCT01907100) was initially designed as a Phase 2 trial, comparing the nintedanib combination to chemotherapy in a blinded manner. But as an internal data monitoring committee reviewed the data, they recommended extending the study in a larger, Phase 3 part.
The recruited patients will not have received any earlier treatment and will be randomized to receive either nintedanib in combination with Alimta and Platinol or the two chemotherapy drugs alone.
Participants will receive chemotherapy on day one and nintedanib for the remaining days in a 21-day cycle. They will receive a maximum of six cycles. Those who do not progress during the treatment will receive either nintedanib or placebo in a maintenance part of the treatment, which will continue either until the cancer progresses or until they experience unacceptable side effects.
While progression-free survival — the time a patient lives without his or her cancer progressing — is the study’s main outcome measure, researchers will also explore how the treatment affects overall survival.
In addition, researchers will gather samples for the analysis of biomarkers — factors produced by the tumor that can tell scientists something about the cancer’s severity, prognosis, or susceptibility to treatment.
Phase 2 results showed that participants treated with the three-drug combo had a progression-free survival of 9.4 months, compared with 5.7 months in the chemotherapy control group.
Those with epithelioid-type cancer benefited even more, with a median progression-free survival of 9.7 months. Overall survival was also better with the nintedanib combination. Meanwhile, safety was similar in the two groups.
The study is currently recruiting, and interested patients can find information about locations and contacts on this section of the trial page.
Nintedanib is approved for the treatment of non-small-cell lung cancer both in the U.S. and Europe under the brand name Vargatef. In addition, the drug is marketed as Ofev for use in patients with pulmonary fibrosis.