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Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the safety and effectiveness of Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma (HNSCC). This phase 3 randomized, double-blind, placebo-controlled study focuses on patients who have completed chemoradiation therapy with cisplatin and radiation and have no distant metastatic disease. The study requires confirmation of PD-L1 positive tumor status and specific testing for oropharyngeal carcinoma cases. Participants will receive either Dostarlimab or a placebo as an intravenous infusion following their chemoradiation treatment. The study monitors these treatments as sequential therapy to assess their impact on disease progression. Treatments are administered in a controlled, blinded manner to compare outcomes between the two groups effectively. During the study, participants will be followed for up to approximately five years to measure event-free survival, with evaluations conducted by blinded independent central review. Assessments will include monitoring for safety, disease status, and any adverse events throughout the study period. This long-term follow-up aims to provide comprehensive data on the effectiveness and safety of Dostarlimab as post-chemoradiation therapy in this patient population.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the effectiveness and safety of combining ficlatuzumab with cetuximab compared to cetuximab alone in adults with recurrent or metastatic human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). This phase 3 study focuses on participants whose cancer has returned or spread and who have previously been treated with anti-PD-1/PD-L1 immune checkpoint inhibitors and platinum-based chemotherapy. The main goal is to see if the combination improves progression-free survival and overall survival. Participants will be randomly assigned to one of three groups: two groups will receive different doses of ficlatuzumab plus cetuximab, and the third group will receive a placebo plus cetuximab. Treatments involve infusions of biological agents, with ficlatuzumab being a monoclonal antibody targeting hepatocyte growth factor (HGF) and cetuximab being an epidermal growth factor receptor (EGFR) antagonist. The study will enroll about 410 participants and is double-blinded, meaning neither participants nor researchers know who is receiving ficlatuzumab or placebo. During the study, participants will be monitored regularly through imaging scans (CT or MRI) to measure tumor response, along with physical exams and laboratory tests. Researchers will track overall survival from the time of randomization until death from any cause, which may take approximately 44 months. Safety assessments and compliance with study procedures will also be closely observed throughout the trial.

Researchers are evaluating Risvutatug rezetecan (Ris-Rez), a new medicine that targets specific proteins called B7-H3 on cancer cells to reduce the cancer's ability to grow and spread. This study focuses on participants with relapsed extensive-stage small cell lung cancer (ES-SCLC) who have previously received platinum-based systemic therapy combined with a PD-(L)1 inhibitor. The trial aims to compare how well Ris-Rez works versus the standard treatment topotecan in shrinking tumors or making them disappear, and whether Ris-Rez helps participants live longer. The study also assesses the safety and tolerability of Ris-Rez compared to topotecan and gathers information on side effects of both treatments. Participants will be randomly assigned to receive either Ris-Rez, administered as a biological treatment, or topotecan, given as a drug treatment. The study is a phase 3, multicenter, randomized, open-label clinical trial. Both treatments will be provided according to the study protocol, and participants will be monitored carefully throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response using RECIST 1.1 criteria and overall survival for up to approximately 113 weeks. Researchers will also evaluate participants' organ function, performance status, and side effects. Safety monitoring includes checking for cardiovascular health, infections, bleeding, and lung conditions. The study requires participants to provide informed consent and comply with study procedures and restrictions throughout their involvement.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with locally advanced, unresectable, or metastatic stomach or gastroesophageal junction (GEJ) cancer. This study focuses on cancer cells that are HER2-negative but positive for the Claudin 18.2 protein and PD-L1, exploring how well zolbetuximab helps the immune system attack the tumor alongside immunotherapy and chemotherapy. The trial is a phase 3, randomized, double-blind study designed to compare the overall survival of participants receiving zolbetuximab with pembrolizumab and chemotherapy versus those receiving a placebo with pembrolizumab and chemotherapy. Participants receive study treatment in 6-week cycles, with zolbetuximab or placebo given by infusion every 2 or 3 weeks. Chemotherapy regimens include either CAPOX (capecitabine tablets and oxaliplatin infusion) or mFOLFOX6 (infusions of 5-fluorouracil, folinic acid, and oxaliplatin) administered on schedules matching the cycles. Pembrolizumab is infused every 3 or 6 weeks. Treatment continues until cancer worsens, is not tolerated, or another therapy is needed, with pembrolizumab given for up to 2 years. After initial cycles, some chemotherapy drugs are adjusted to only include oral capecitabine or certain infusions. During the study, participants visit the clinic for treatments, health checks, and scans to monitor cancer changes and side effects. Researchers also track medical problems related to the treatments and may collect tumor samples if cancer worsens. After stopping treatment, participants have follow-up visits and scans every 9 to 12 weeks, along with telephone check-ins every 3 months. The primary outcome measured is overall survival up to 72 months, with ongoing monitoring to evaluate safety and treatment effects.

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.