Late-Phase Clinical Trials

This phase 3 study is comparing palazestrant plus ribociclib with letrozole plus ribociclib for adults with ER-positive, HER2-negative advanced breast cancer. It is enrolling women and men who have not received prior systemic anti-cancer treatment for advanced disease. Participants will be randomly assigned to one of the two treatment arms in a double-blind design.

Merus study of bispecific antibody MCLA-158 in patients with advanced solid tumors including colorectal.

This phase 3 study compares sacituzumab govitecan with standard treatment after prior platinum-based therapy for extensive-stage small cell lung cancer. Researchers are evaluating overall survival. The UCS listing indicates that the study is recruiting.

This phase 3 study is comparing IDRX-42 (also known as GSK6042981) with sunitinib in adults with gastrointestinal stromal tumors (GIST) that have spread or cannot be removed with surgery. Participants must have already received imatinib. The study is evaluating how well the treatment works and how safe it is.

AstraZeneca global study of Volrustomig (MEDI5752) in unresected locally advanced head and neck squamous cell carcinoma following chemoradiotherapy.

This phase 3 trial compares BGB-43395 with standard CDK4/6 inhibitors, each combined with letrozole, for advanced or metastatic HR+/HER2- breast cancer. It evaluates effectiveness and safety in participants who have not received systemic treatment for advanced or metastatic disease.

This phase 3 study is testing ivonescimab versus pembrolizumab as a first treatment for people with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression. The study is looking at outcomes such as overall survival and progression-free survival. Participants must be adults with stage IV NSCLC and no prior systemic treatment for metastatic disease.

This is a phase 2/3, multicenter study for people with first-line non-small cell lung cancer (NSCLC). Participants are randomized to receive BNT327 (pumitamig) with chemotherapy, and the study includes two substudies based on tumor subtype. The trial is recruiting and is designed to evaluate safety, effectiveness, and pharmacokinetics.

This phase 3 study is testing pasritamig (JNJ-78278343) plus best supportive care versus placebo plus best supportive care in people with metastatic castration-resistant prostate cancer. The main goal is to see whether pasritamig helps people live longer. It is recruiting participants at multiple centers in the United States.

This phase 3 study is testing whether ivonescimab plus FOLFOX works better than bevacizumab plus FOLFOX as a first treatment for metastatic colorectal cancer. The trial is randomized, double-blind, and active-controlled, and it includes about 600 participants who have not previously received systemic therapy for metastatic disease. Treatment is given intravenously, followed by maintenance therapy for up to 2 years.

Guardant Health observational study of residual cancer detection using liquid biopsy across multiple cancer types including bladder, NSCLC, breast, melanoma, and others.

This phase 2 study is evaluating INCB123667 in people with platinum-resistant ovarian cancer that overexpresses Cyclin E1. The study is looking at the safety and effectiveness of this treatment in participants who have already received prior therapy. It is a single-arm study, so all participants receive the study drug.

This phase 3 trial is evaluating trastuzumab deruxtecan plus bevacizumab versus bevacizumab alone as first-line maintenance treatment for HER2-expressing advanced high-grade ovarian cancer. Participants must have newly diagnosed stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer and have already received standard bevacizumab with platinum-based chemotherapy. A safety run-in phase is planned before randomization.

This phase 3 study is testing whether setidegrasib, given with standard chemotherapy, can help people with metastatic pancreatic cancer that has a KRAS G12D mutation. Participants are assigned by chance to receive setidegrasib or placebo along with mFOLFIRINOX or NALIRIFOX, which the study doctor selects. The main goal is to see whether the study treatment helps people live longer and to assess safety.