Untreated PD-L1 non-small cell lung cancer (NSCLC). Patients with previously untreated, PD-L1-selected, locally advanced, unresectable, or metastatic NSCLC will be enrolled in a phase 3 study comparing pembrolizumab with the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD -1 checkpoint) wanted inhibitor). Participants will be treated until death or disease progression, whichever comes first, for up to approximately 39 months. The multinational study began recruiting on June 8 and is hoping to have 605 participants. US study centers are located in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary endpoint and quality of life (QoL) is followed. See Clinicaltrials.gov for more details.

Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, unresectable stage III NSCL are recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months after randomization, whichever comes first. Study enrollment began on June 17 at the Central Care Cancer Center in Bolivar, Missouri. OS and QoL over 16 months are secondary endpoints. See Clinicaltrials.gov for more details.

Limited stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, 8th edition) can participate in a phase 2 study in which the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone. The study lasts 30 months from the date of the first study enrollment. The investigators want to recruit 120 employees worldwide. US locations are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary endpoint. OS over 30 months is a secondary endpoint. QoL is not tracked. More details are available at Clinicaltrials.gov.

Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA will be recruited into a phase 3 study to test whether circulating cancer cells in the blood are determined by combining the standard treatment durvalumab with platinum doublet chemotherapy (carboplatin / Pemetrexed or carboplatin / paclitaxel). Patients will receive durvalumab for 1 year with or without four courses of chemotherapy. The study opened on August 25 at Stanford University in Stanford, California. OS over 2 years is a secondary endpoint. QoL is not assessed. More details are available at Clinicaltrials.gov.

Untreated Stage IV NSCLC. Patients with stage IV non-squamous NSCLC who were not treated for metastatic disease are being recruited into a phase 2 study of experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. The participants are treated for about 2 years. The objective response rate is the primary endpoint. OS over 4 years is a secondary endpoint. QoL is not assessed. The trial opened on September 30th in Arkansas, California, Minnesota, Ohio and Texas. More details are available at Clinicaltrials.gov.

Untreated metastatic NSCLC. Patients with metastatic squamous cell carcinoma or non-squamous cell NSCLC are being sought for a phase 3 study comparing a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both of which are given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until disease progression or unbearable side effects occur, or the participant / doctor decides to discontinue therapy. The pharmacokinetic performance of the drug is the primary endpoint. As a secondary endpoint, the OS is analyzed over a period of 5 years. QoL is not assessed. The international study has US locations in Florida, Montana, Tennessee, Texas and Virginia. More details are available at Clinicaltrials.gov.

All study information is from the National Institutes of Health’s US National Library of Medicine (online at Clinicaltrials.gov).

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