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Researchers are studying whether the medicines calderasib and subcutaneous pembrolizumab can be used together to treat non-small cell lung cancer (NSCLC) in people with a specific KRAS G12C mutation. The main goal is to find out if patients receiving calderasib plus pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. Participants will be randomly assigned to one of two groups: one group will receive pembrolizumab and berahyaluronidase alfa as a subcutaneous injection every 6 weeks for up to about 2 years plus calderasib pills daily until treatment needs to stop. The other group will receive the same pembrolizumab and berahyaluronidase alfa injections plus chemotherapy drugs (pemetrexed with either carboplatin or cisplatin) delivered by intravenous infusion at specific days during the treatment cycles. Throughout the study, participants will be closely monitored for how long they live without cancer progression, overall survival, response to treatment, and quality of life using questionnaires and other assessments. The study will track side effects and any reasons for stopping treatment over several years, with evaluations continuing for up to about 81 months. This long-term follow-up helps researchers understand the safety and impact of these treatments over time.

Researchers are evaluating the efficacy and safety of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with the same chemotherapy for first-line treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) at 1% or higher. This Phase III, randomized, double-blind, global study focuses on patients with squamous mNSCLC without actionable genomic mutations and assesses these treatments over approximately five years. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle, combined with carboplatin and paclitaxel or nab-paclitaxel chemotherapy. Chemotherapy is given up to 4 cycles, with nab-paclitaxel administered on Days 1, 8, and 15 of each cycle. After chemotherapy, patients continue with the assigned immunotherapy drug. The study compares these two treatment regimens as first-line therapy. During the study, participants undergo regular assessments including imaging to measure tumor response, survival, and disease progression up to about five years. Researchers also monitor physical functioning, quality of life, lung cancer symptoms, and drug pharmacokinetics and immunogenicity. Safety is closely followed, and overall survival and progression-free survival are the primary outcomes measured to evaluate the treatments' impact.

Researchers are evaluating the safety and effects of L606 in people with high blood pressure in the lungs caused by interstitial lung disease, known as pulmonary hypertension associated with interstitial lung disease (PH-ILD, WHO Group 3). This phase 3 study aims to see if L606 helps people walk further in six minutes and to monitor how long it takes for their condition to worsen. The study is sponsored by Liquidia Technologies, Inc. and includes close monitoring for side effects to ensure safety. Participants are randomly assigned to receive either L606, delivered as a liposomal form of treprostinil via a nebulizer, or a placebo that looks like L606 but contains no active medicine. After the initial blinded phase, those who join may enter an open-label extension where everyone receives L606. This helps researchers compare the effects of L606 versus placebo over time. During the study, participants will take the six-minute walk test to measure how far they can walk. Doctors will assess changes in walking distance at 16 and 24 weeks, and track serious events like hospitalization, lung transplant, or death. The study includes regular evaluations for side effects and safety. Participation lasts through the initial treatment and may continue into the extension phase, with ongoing monitoring.

Researchers are evaluating the safety and effectiveness of two doses of inhaled pirfenidone (AP01) compared to a placebo, alongside standard care, in people with progressive pulmonary fibrosis (PPF) over a 52-week period. This randomized, double-blind, placebo-controlled Phase 2b study aims to better understand treatment options for individuals with PPF, a condition characterized by worsening lung fibrosis despite existing therapies. Participants will be randomly assigned to one of three groups: a high dose of AP01 twice daily, a low dose of AP01 twice daily, or a placebo inhalation twice daily. The study involves taking inhaled treatments using a pirfenidone solution or placebo, with the goal to evaluate the impact of these treatments on lung function and disease progression over one year. Throughout the study, participants will undergo regular assessments including lung function tests, imaging scans, and quality of life evaluations. Researchers will monitor the effect of the treatments on lung fibrosis, respiratory symptoms, and safety measures. The total participation lasts for 52 weeks, during which participants will attend scheduled visits and complete various tests to track their health and response to the study treatments.

Researchers are evaluating the effects of ROC-101 in adults with Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension associated with Interstitial Lung Disease (ILD-PH). This Phase 2a, open-label, single-arm study aims to assess the safety, tolerability, and efficacy of oral ROC-101 in combination with standard of care (SOC) therapy. The study focuses on patients classified under World Health Organization (WHO) Group I PAH or Group III ILD-PH, monitoring clinical and hemodynamic parameters. Participants will receive ROC-101 orally once daily, starting at 10 mg with a planned increase to 40 mg daily during a 24-week treatment period alongside their SOC therapy. Following this main phase, participants may continue in a long-term extension phase until the study program ends or regulatory approval is obtained. Evaluations include detailed hemodynamic measurements taken during right heart catheterization (RHC) and monitoring of adverse events. Throughout the study, participants will undergo various assessments including pulmonary function tests, 6-minute walk distance evaluations, and multiple heart catheterization measurements to track changes in pulmonary vascular resistance and other cardiac functions. Safety will be closely monitored by recording adverse events. Participants are expected to comply with study procedures and contraceptive guidelines as applicable, with total participation lasting beyond 24 weeks if they join the extension phase.

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations: encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous (IV) infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

Researchers are studying the treatment LTP001 to assess its safety, tolerability, and how the body processes it in healthy adults (Part A). They are also evaluating the safety and effectiveness of LTP001 in people diagnosed with pulmonary arterial hypertension (PAH) in Part B, followed by a safety extension phase. This research aims to better understand the treatment's impact on PAH and is sponsored by Novartis Pharmaceuticals. In Part A, healthy adult volunteers receive single and multiple ascending doses of LTP001 or a matching placebo in a randomized, double-blind setup. Part B involves participants with PAH who are randomized to receive different doses of LTP001 or placebo alongside their standard PAH treatment. The study includes a treatment period of up to 24 weeks, followed by an extended safety monitoring period lasting up to 106 weeks. Participants will undergo various assessments including monitoring for adverse events, evaluation of pulmonary vascular resistance, six-minute walk tests, and measurements of biomarkers like NT-proBNP. Blood samples will be collected to study drug levels and how it is metabolized. Safety and functional status will be checked regularly throughout both parts of the study, with participant involvement lasting over 2 years for long-term follow-up.

Researchers are evaluating how well active surveillance helps doctors monitor patients with low-risk germ cell tumors after surgical removal. The study also compares chemotherapy treatments using carboplatin versus cisplatin in pediatric, adolescent, and young adult patients with metastatic standard risk germ cell tumors. It aims to determine overall survival, event-free survival, and side effects such as hearing loss among these patients. The study includes patients with low-risk stage I ovarian immature teratoma or stage I non-seminoma or seminoma germ cell tumors who undergo observation. Patients with standard risk tumors are randomly assigned to receive one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin, given intravenously on specific days over cycles repeating every 21 days. Treatments continue for up to 3 or 4 cycles if no disease progression or unacceptable side effects occur. Throughout treatment and observation, patients undergo imaging scans, blood sample collection, tumor biopsies if needed, and pulmonary function tests. Participants will be followed with regular imaging and blood tests to monitor tumor response and recurrence, including CT, MRI, and chest x-rays. Follow-up visits occur every 2 months for the first year, then every 3 to 6 months through year 2, every 6 months for years 3 to 5, and annually up to 10 years. The study also assesses hearing outcomes, body composition, tumor marker decline, neuropathy, and serum microRNA over time to better understand treatment effects and patient quality of life.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy treatment can improve outcomes for adults with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial compares standard chemotherapy alone to chemotherapy combined with durvalumab. Previous evidence suggests patients with this specific cancer profile may respond better to chemotherapy and immunotherapy, so this study aims to see if durvalumab helps prevent cancer from returning. Participants are first screened with MammaPrint testing on tumor tissue to confirm MP2 status. Those eligible are then randomly assigned to one of two treatment groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously during specific cycles. Mammography is done during screening, and optional tumor tissue and blood samples are collected throughout the study. During the trial, participants undergo regular assessments including mammograms, tissue biopsies, and blood tests to monitor response and safety. Researchers measure event-free survival, pathologic complete response, residual cancer burden, distant relapse-free survival, and overall survival for up to 10 years after treatment. Quality of life is also evaluated through questionnaires during and after treatment. Participants are followed long-term to track outcomes and side effects.