Search Bar & Filters
Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.
Actively Recruiting
Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.
Actively Recruiting
Researchers are evaluating the effects of continuing cetuximab treatment beyond first-line progression in adults with metastatic colorectal cancer whose tumors have specific genetic characteristics, including RAS and BRAF wild-type status. This Phase 3 trial aims to compare chemotherapy combined with cetuximab against chemotherapy combined with bevacizumab to see if cetuximab continuation improves tumor response, progression-free survival, overall survival, and safety. The study builds on earlier trials suggesting potential benefits of cetuximab continuation in this patient group. Participants will receive a standard chemotherapy regimen, either FOLFOX or FOLFIRI, combined with either cetuximab or bevacizumab every two weeks. Cetuximab is administered as an intravenous infusion of 500 mg/m² every 14 days, while bevacizumab is given at 5 mg/kg every 14 days. Treatment continues until disease progression, unacceptable side effects, or withdrawal of consent. Tumor response will be regularly assessed using imaging scans according to RECIST criteria. Throughout the study, patients will undergo regular CT or MRI scans, laboratory tests, and clinical evaluations to monitor disease status and safety. Biological samples such as tumor tissue, blood, and stool will be collected for research on treatment resistance and the gut microbiome. The primary outcome is the overall response rate measured from randomization until progression, death, or study completion, with assessments continuing up to 48 months. Approximately 360 patients will participate across sites in Italy and Spain.
Actively Recruiting
Researchers are evaluating neladalkib (NVL-655) compared to alectinib in patients with treatment-na efve, ALK-positive advanced Non-Small Cell Lung Cancer (NSCLC). This Phase 3, multicenter, randomized, controlled, open-label study aims to show that neladalkib can prolong progression-free survival (PFS) better than alectinib in this patient group. Patients included have advanced or metastatic NSCLC confirmed to have ALK rearrangement and have not received prior systemic anticancer treatments for NSCLC. Participants will be randomly assigned in a 1:1 ratio to receive either oral neladalkib tablets or oral alectinib capsules. Each group will have approximately 225 patients. Treatment will be given as first-line therapy without prior ALK tyrosine kinase inhibitor use. The study monitors the patients over time to compare the effectiveness of these two drugs in controlling the disease. During the study, researchers will assess progression-free survival up to 5 years after the first patient is dosed, using blinded independent central review. Patients will have measurable disease and provide pretreatment tumor tissue for evaluation. Safety monitoring includes tracking heart rhythm, infections, and other health conditions. The study excludes patients with certain infections, recent major surgery, or other active cancers requiring therapy. This comprehensive follow-up aims to evaluate how well each treatment controls cancer progression and its safety over time.