Immenhausen

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously completed treatment with the drug nerandomilast. The study aims to understand how well participants tolerate long-term treatment with nerandomilast and whether it helps improve lung function or delays worsening symptoms, hospitalizations, or death. This is a phase 3 open-label extension trial sponsored by Boehringer Ingelheim. Participants will take nerandomilast tablets daily for up to 1 year and 10 months. They may continue their usual treatments for pulmonary fibrosis alongside the study treatment. There is no placebo group, and all participants receive nerandomilast during this extension period. Throughout the study, participants will visit their doctors regularly for health check-ups and lung function tests. Researchers will closely monitor any side effects and changes in lung function, particularly forced vital capacity FVC, over nearly two years. The study will track time until symptom worsening, hospital visits, or death to assess the treatments long-term safety and effects.

Researchers are evaluating rilvegostomig compared with pembrolizumab monotherapy as a first-line treatment for people with metastatic non-small cell lung cancer mNSCLC whose tumors have high PD-L1 expression. This Phase III, global, randomized, and double-blind study aims to assess the efficacy and safety of these treatments in this patient population. The trial is sponsored by AstraZeneca and focuses on patients with specific tumor characteristics and no certain genetic mutations. Participants will receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study has two treatment arms one for the investigational drug rilvegostomig and one for the active comparator pembrolizumab. Both treatments are given as monotherapy to understand their effects as initial therapy in this cancer setting. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately 5 years. Additional assessments include tumor response, duration of response, time to second progression or death, drug pharmacokinetics, immunogenicity, and patient-reported outcomes related to physical function, quality of life, and lung cancer symptoms. The study involves regular evaluations to track treatment effects and safety over an extended period.

Researchers are evaluating the effectiveness and safety of combining divarasib and pembrolizumab compared to pembrolizumab with pemetrexed and carboplatin or cisplatin for first-line treatment in adults with KRAS G12C-mutated advanced or metastatic non-squamous non-small cell lung cancer NSCLC. This phase III study focuses on patients who have not received prior systemic treatment for this type of lung cancer and aims to provide new options for this specific mutation. Participants are randomly assigned to one of two groups. One group receives an oral daily dose of divarasib along with pembrolizumab given by intravenous infusion every three weeks. The other group receives pembrolizumab combined with pemetrexed and either carboplatin or cisplatin, also administered intravenously every three weeks. Treatments continue according to the study schedule to assess how well each combination works and their safety profiles. Throughout the study, participants will be closely monitored for progression-free survival and overall survival for up to approximately five years. Additional assessments include tumor response, quality of life related to lung cancer symptoms, duration of response, and side effects reported by patients. Safety is also tracked by recording adverse events and their impact on daily activities. This comprehensive monitoring helps researchers understand the full effects of the treatments over time.

Researchers are evaluating the anti-tumor activity and safety of amivantamab given as a subcutaneous co-formulation with recombinant human hyaluronidase PH20 rHuPH20 in participants with advanced or metastatic non-small cell lung cancer NSCLC, including those with specific EGFR mutations. This Phase 2, open-label study includes multiple cohorts with different treatment histories and EGFR mutation types to better understand how amivantamab works in combination with other therapies and to assess its safety profile. Participants receive amivantamab subcutaneously at varying doses based on body weight and specific treatment cohorts. Some cohorts combine amivantamab with oral lazertinib or intravenous chemotherapy drugs such as carboplatin and pemetrexed, administered on different schedules ranging from every two to three weeks in 21- or 28-day cycles. Additional treatments like prophylactic anticoagulation may also be given in certain cohorts. Participants may have the option to enter a long-term extension phase to continue receiving study treatments. During the study, participants undergo regular evaluations including tumor assessments based on RECIST criteria and safety monitoring through adverse event tracking and laboratory tests. Researchers will measure objective response rates and other outcomes up to 1 year and 6 months, and for some cohorts, safety will be monitored for up to nearly 5 years. Participants quality of life and treatment satisfaction are also assessed. The total duration of participation varies according to cohort and treatment response, with follow-up continuing after treatment completion.

Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan I-DXd compared with treatments chosen by physicians for adults with relapsed extensive-stage small cell lung cancer SCLC. This Phase 3 randomized study aims to see if I-DXd can improve objective response rates and prolong overall survival compared to other standard treatments. The study also examines other factors such as patient-reported outcomes, immunogenicity, B7-H3 protein expression, and pharmacokinetics of I-DXd. Participants are randomly assigned to one of two groups. One group receives I-DXd at a dose of 12 mgkg intravenously on Day 1 of each 21-day cycle until unacceptable side effects, disease progression, or withdrawal. The other group receives one of three treatmentstopotecan, lurbinectedin, or amrubicinbased on the doctors choice and local guidelines, continuing until treatment criteria for stopping are met. No placebo is used, and the study is open-label. During the study, participants will have tumor assessments and survival monitored up to about five years. Evaluations include measuring tumor response by independent review and investigators, progression-free survival, duration of response, quality of life questionnaires, safety monitoring for adverse events, and tests of drug levels in the blood. Participants will be followed for disease progression, treatment effects, and survival throughout the study period, which may last several years.

Researchers are evaluating the combination of Navlimetostat BMS-986504, pembrolizumab, and chemotherapy compared to placebo plus pembrolizumab and chemotherapy in participants with first-line metastatic non-small cell lung cancer NSCLC who have a homozygous MTAP deletion. This randomized phase 23 study focuses on metastatic NSCLC participants with no prior systemic treatment for metastatic disease and aims to assess clinical benefits of adding Navlimetostat to standard treatments. Participants are assigned to one of several study groups receiving either the combination of BMS-986504, pembrolizumab, and chemotherapy drugs including cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel or placebo with pembrolizumab and chemotherapy. Each drug is given at specified doses on specified days. The study uses a quadruple-blind method to compare these treatments over time. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, evaluations of progression-free survival and overall survival up to five years, and monitoring for treatment-related side effects. Researchers will also track the duration and timing of tumor responses and collect safety data up to 90 days after last treatment. The total participation duration may extend up to five years for long-term outcome assessments.

Researchers are evaluating Pumitamig compared to Durvalumab in people with unresectable stage III non-small cell lung cancer NSCLC who have completed platinum-based concurrent chemoradiation therapy without disease progression. This phase 3, randomized study aims to compare these treatments in participants with good performance status after prior therapy. The trial is sponsored by Bristol-Myers Squibb and focuses on progression-free survival as the main outcome. Participants will receive either Pumitamig or Durvalumab at specified doses on certain days as part of the study treatment. The study is open-label, meaning both the researchers and participants know which treatment is given. Treatment will follow completion of at least two cycles of platinum-based chemoradiation with a radiation dose of at least 54 Gy and no disease progression after that therapy. Throughout the study, participants will be regularly monitored with scans and assessed for progression-free survival by blinded independent central review using standard criteria. Other outcomes include overall survival, objective response, disease control rate, and duration of response, observed for up to approximately nine years. Safety and disease status will be closely followed to evaluate the treatments over time.

This research aims to assess the long-term safety and explore the effects of astegolimab in adults with chronic obstructive pulmonary disease COPD who have completed a 52-week treatment period in earlier studies named GB43311 or GB44332. The study is an open-label extension phase III trial sponsored by Hoffmann-La Roche, focusing on participants aged 40 to 90 years. Participants who qualify from the parent studies will receive astegolimab through subcutaneous injections every two weeks throughout the study duration. This open-label extension allows all participants to receive the active drug without placebo comparison. During the study, researchers will monitor participants for any adverse events up to 12 weeks after the last dose, focusing on the safety of astegolimab. Participants will be regularly assessed to track any side effects and overall health changes related to their COPD condition while on this treatment. The study began in June 2023 and will continue until July 2034, allowing for long-term observation.

Small cell lung cancer SCLC is a fast-growing cancer that often spreads early to various parts of the body such as lymph nodes, liver, bones, adrenal glands, and brain. This research is evaluating the safety, dosage, and disease activity changes of an investigational drug called ABBV-706 when given with atezolizumab, compared to the current standard treatment that includes etoposide, carboplatin, atezolizumab, and optionally lurbinectedin. The study is a phase 2 trial involving about 180 adults with untreated extensive stage SCLC. Participants will be randomly assigned to receive one of two doses of ABBV-706 combined with atezolizumab or the standard of care treatment. All treatments are given intravenously and continue until the best ABBV-706 dose is identified. The study includes a safety lead-in phase and an expansion phase, with the entire study lasting up to about 69.5 months. The standard care group may receive etoposide, carboplatin, atezolizumab, and optionally lurbinectedin. During the study, participants will visit hospitals or clinics regularly for medical assessments, blood tests, questionnaires, and scans. Researchers will monitor safety by recording adverse events and evaluate how well the disease is controlled using progression-free survival and response rates over about 24 months. Overall survival will also be assessed. The study will closely track participants health and treatment effects throughout the 69.5-month period.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase 3 study includes participants who have had at least two moderate or one severe COPD exacerbations in the past year despite inhaled maintenance therapy. The goal is to better understand if tezepelumab can reduce the rate of COPD exacerbations and improve lung function and quality of life. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo for a treatment period lasting between 52 and 76 weeks. After the treatment phase, there is a 12-week off-treatment safety follow-up. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives the active medication or placebo. During the study, participants will have regular assessments including lung function tests, questionnaires about respiratory health and symptoms, and blood samples to measure drug levels and immune response. Researchers will track COPD exacerbation frequency, lung function changes, and symptom improvements. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods, with total participation lasting up to approximately 88 weeks.