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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.
Actively Recruiting
Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.
Actively Recruiting
Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.
Actively Recruiting
Researchers are evaluating whether continuing cetuximab treatment beyond first-line progression can improve outcomes in adults with metastatic colorectal cancer who have tumors that are RAS and BRAF wild-type. This Phase 3 clinical trial aims to compare chemotherapy combined with cetuximab versus chemotherapy combined with bevacizumab, focusing on tumor response, progression-free survival, overall survival, and safety. The study builds on prior trials suggesting potential benefits of cetuximab continuation in this patient group. Participants will be randomly assigned to receive either FOLFOX or FOLFIRI chemotherapy combined with cetuximab experimental group or bevacizumab control group. Treatments are given every two weeks, with cetuximab administered as a 120-minute intravenous infusion at 500 mgm and bevacizumab at 5 mgkg. Therapy continues until disease progression, unacceptable side effects, or patient withdrawal. Tumor response will be assessed by independent review using RECIST criteria. During the study, patients undergo regular CT or MRI scans, laboratory tests, and clinical evaluations. Biological samples such as tumor tissue, blood, and stool are collected for research on resistance mechanisms and the gut microbiome. The primary measure is the overall response rate assessed up to 48 months, with secondary outcomes including overall survival, progression-free survival, and safety monitored throughout treatment and up to 30 days after the last dose. Participation lasts through treatment and follow-up periods up to several years.
Actively Recruiting
Researchers are studying the effectiveness of neladalkib NVL-655 compared to alectinib in patients with advanced Non-Small Cell Lung Cancer NSCLC that tests positive for Anaplastic Lymphoma Kinase ALK and who have not received prior treatment. This Phase 3 trial aims to determine if neladalkib can better prolong the time patients live without disease progression. The study involves patients with advanced or metastatic ALK-positive NSCLC and is sponsored by Nuvalent Inc. Participants will be randomly assigned to one of two groups one group will take neladalkib 150 mg orally once daily, and the other will take alectinib 600 mg orally twice daily. Both treatments are given as oral pills, and the study compares these two drugs directly. Patients will be followed for up to 5 years after starting treatment to assess outcomes. During the trial, patients will undergo regular assessments including tumor measurements based on RECIST 1.1 criteria, brain imaging to monitor intracranial progression, and laboratory tests. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, adverse events, and patient-reported quality of life and lung cancer symptoms. The study will last until December 2029, with close follow-up to evaluate long-term effects and safety.