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Researchers are evaluating new treatments for locally advanced non-small cell lung cancer NSCLC that cannot be surgically removed and has a specific gene mutation called KRAS G12C. This trial aims to find out if the combination of calderasib MK-1084 and durvalumab can help participants live longer without their cancer growing or spreading compared to durvalumab with a placebo after they have completed chemotherapy and radiation therapy. Participants will be randomly assigned to receive either calderasib along with durvalumab or a placebo along with durvalumab. Calderasib is taken by mouth as a tablet, and durvalumab is given as an intravenous infusion. This study is double-blinded, meaning neither the participants nor the researchers know who receives the active drug or placebo. The treatment period will be followed by long-term monitoring. During the study, participants will have various assessments including survival monitoring up to approximately 9 years, evaluations of adverse events, response rates, and quality of life questionnaires. Researchers will also collect tumor tissue samples for biomarker analysis. The main measurement is progression-free survival, checked for up to about 6 years. Participants health and side effects will be closely tracked throughout and after treatment.

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.

Researchers are evaluating the safety, pharmacokinetics, and activity of divarasib either alone or combined with other anti-cancer treatments in adults with previously untreated advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. This study includes participants with locally advanced unresectable or metastatic NSCLC who have not received prior systemic treatment for their advanced disease. The trial is open-label and includes multiple phases to assess different dosing and combinations of therapies. Participants are assigned to different groups to receive divarasib daily by mouth, alone or combined with pembrolizumab given intravenously every three weeks. Some groups also receive a platinum-based chemotherapy carboplatin or cisplatin and pemetrexed alongside divarasib and pembrolizumab. Different dose levels of divarasib are being tested, with some participants randomized during an expansion phase to receive one of two combination dose levels. Treatment cycles last 21 days and treatments are given according to these schedules. Throughout the study, participants undergo regular monitoring for safety and treatment effects, including assessments of adverse events from baseline until 60 days after the last dose or until starting another cancer therapy. Researchers also evaluate response rates, duration of response, progression-free survival, and symptom changes over approximately five years. Tests include patient questionnaires about side effects and quality of life, as well as measurements of divarasib levels in the body. The study aims to identify recommended doses and assess responses, including in the central nervous system, with ongoing safety monitoring during and after treatment.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

Researchers are investigating whether intismeran autogene, combined with pembrolizumab and chemotherapy, can help treat people with metastatic squamous non-small cell lung cancer NSCLC who have not received prior treatment. The study aims to determine if this combination improves overall survival and delays cancer growth or spread compared to pembrolizumab and chemotherapy with a placebo. Intismeran autogene is designed to stimulate the immune system to attack the cancer. Participants are divided into two groups. In the induction phase, all receive pembrolizumab through intravenous IV infusion on Day 1 of a six-week cycle plus platinum-based chemotherapy every three weeks, combined with either paclitaxel or nab-paclitaxel, depending on the group. The study treatment or placebo is given by intramuscular IM injection on Days 1 and 22 during the second cycle of induction. During the maintenance phase, pembrolizumab is given every six weeks for up to 15 doses, and the study treatment or placebo is administered by IM injection on Days 1 and 22 every three weeks for up to 7 doses. Throughout the study, participants undergo regular assessments including imaging to measure cancer progression and survival. Researchers monitor overall survival and progression-free survival for up to about 42 months. Additional outcomes include response rates to treatment and adverse events. Participants are closely observed for safety, and the study lasts several years to evaluate long-term effects and benefits of the treatment combination.

Researchers are evaluating whether adding zilovertamab vedotin to a standard treatment regimen can help people with previously untreated diffuse large B-cell lymphoma DLBCL live longer without the cancer growing or spreading. This phase 3 randomized study compares the combination of zilovertamab vedotin with rituximab plus cyclophosphamide, doxorubicin, and prednisone R-CHP against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone R-CHOP. The trial is sponsored by Merck Sharp & Dohme LLC and aims to improve treatment outcomes for people with this type of lymphoma. Participants receive treatment in cycles lasting 21 days, for up to 6 cycles approximately 4 months. One group receives zilovertamab vedotin plus rituximab or a rituximab biosimilar, cyclophosphamide, doxorubicin, and prednisone or prednisolone or methylprednisolone, while the comparison group receives rituximab or biosimilar, cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone or methylprednisolone. Both groups may receive 2 additional cycles of rituximab or biosimilar if they have high-risk DLBCL. All infusions are given intravenously on Day 1 of each cycle, with prednisone or similar drugs taken orally on Days 1-5 of each cycle. Throughout the study, participants are closely monitored for progression-free survival up to about 50 months, as well as other outcomes such as overall survival, response to treatment, adverse events, and quality of life changes. Assessments include clinical evaluations during treatment and follow-up periods, with safety monitoring continuing for up to 9 months. This comprehensive follow-up helps researchers understand the effects and tolerability of the treatments over time.

Researchers are evaluating zongertinib, an oral drug targeting HER2 mutations, to see if it can improve outcomes compared with standard adjuvant treatments in adults who have had complete surgical removal of Stage II-IIIB non-small cell lung cancer NSCLC with activating HER2 tyrosine kinase domain mutations. This Phase 3, global, randomized, open-label study involves participants who have already received appropriate perioperative systemic therapy, including neoadjuvant or adjuvant platinum-based chemotherapy, with or without immunotherapy. Participants are randomly assigned in equal numbers to receive either zongertinib once daily by mouth for up to 3 years or standard treatment, which may include approved adjuvant immunotherapy or observation depending on local guidelines and patient status. The study compares disease-free survival between these groups and also monitors safety and patient-reported outcomes. Tumor samples are collected centrally to confirm HER2 status. During the study, participants undergo regular assessments to monitor disease status, safety, and quality of life. The primary outcome is disease-free survival, tracked for up to 8 years and 5 months. Secondary outcomes include overall survival and occurrence of significant adverse events over up to 3 years. Participant involvement may last several years, with follow-up continuing after treatment to assess long-term outcomes and safety.

Researchers are investigating advanced small cell lung cancer SCLC in adults to determine if adding a medicine called obrixtamig to the standard treatment of atezolizumab, carboplatin, and etoposide improves survival compared to the standard treatment alone. Obrixtamig is a molecule designed to help the immune system fight cancer. The study also tests a new medical device that measures levels of the tumour marker DLL3. This is a phase III clinical trial sponsored by Boehringer Ingelheim, using a randomized design to compare treatments. Participants are randomly assigned to one of two groups. One group receives obrixtamig together with the standard treatment, while the other group receives only the standard treatment. All treatments are given through infusions into a vein. Participants receiving obrixtamig will stay overnight at the study site after their first two treatments. The study lasts up to three years, during which tumour size and health status are regularly checked. Throughout the study, participants visit the study site regularly for assessments. Doctors monitor tumour response and check for any side effects or unwanted reactions. The main outcome is overall survival measured up to 36 months. Additional outcomes include progression-free survival, symptom changes, response rates, and monitoring of treatment-related side effects. The study team closely tracks participant health and evaluates quality of life using questionnaires during the first year.

Researchers are evaluating the efficacy and safety of trimodulin as an additional treatment to standard care in hospitalized adults with severe community-acquired pneumonia sCAP who require invasive mechanical ventilation IMV. This phase III, randomized, placebo-controlled, double-blind study aims to compare trimodulin plus standard care against placebo plus standard care. The study also investigates detailed pharmacokinetic and pharmacodynamic properties of trimodulin. Participants will be randomly assigned to receive either trimodulin a human immunoglobulin solution containing IgM, IgA, and IgG or a placebo human albumin 1% via intravenous infusion once daily for five consecutive days alongside standard care. After treatment, participants will enter a follow-up phase lasting up to 23 days, including an end-of-follow-up visit or phone call on day 29. If still hospitalized after day 29, extended follow-up continues until discharge or day 90, followed by a closing visit or call around day 91. During the study, participants undergo various assessments including monitoring of mortality rates up to 28 and 90 days, changes in organ failure scores, clinical cure of pneumonia, ventilator and oxygen use, ICU and hospital stay durations, readmission rates, adverse events, lab tests, electrocardiograms, and vital signs. Safety evaluations and outcome measurements occur throughout treatment and follow-up, with total participation lasting up to approximately 90 days.