Udaipur

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the effectiveness, safety, and tolerability of mavorixafor in people aged 12 and older who have congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders. These participants experience repeated and/or serious infections due to low neutrophil levels. The study aims to show clinical benefit by increasing circulating neutrophils and reducing infection rates. Participants will continue their existing treatments, which may include granulocyte-colony stimulating factor (G-CSF), immunoglobulin replacement, prophylactic antibiotics, or observation without active treatment. They will be randomly assigned to receive either mavorixafor or a placebo, with both drugs given according to a set schedule. The study is double-blind and placebo-controlled, conducted across multiple centers. During the study, researchers will monitor participants for up to 52 weeks, focusing on the annual infection rate and the number of participants achieving a positive response in absolute neutrophil count. Participants will undergo regular assessments, including blood tests to measure neutrophil levels and evaluations for infections. The study includes safety monitoring and requires participants to maintain stable doses of their background therapies unless safety concerns arise.

Researchers are evaluating how well etavopivat works to reduce the number of vaso-occlusive crises (painful blood vessel blockages) in adolescents and adults living with sickle cell disease. The study also aims to assess if etavopivat can decrease organ damage, improve exercise tolerance, and reduce fatigue. This is a global Phase 3 study involving participants aged 12 years and older with confirmed sickle cell disease. The study is randomized, double-blind, and placebo-controlled to ensure accurate evaluation of the treatment effects. Participants will receive either etavopivat or a matching placebo by mouth. Which treatment they receive is determined randomly. The study will last about two years, during which participants will take the assigned medication and be monitored closely. Etavopivat is an investigational drug currently under evaluation in multiple studies for sickle cell disease. During the study, participants will have regular assessments including documentation of vaso-occlusive crisis events, blood tests, and physical evaluations. Researchers will track the number of crises that require medical attention over a 52-week period, as well as measures of organ health, exercise ability, and fatigue. Safety and overall health will be monitored throughout the study, with the total participation time lasting approximately two years.

Researchers are evaluating the impact of a group-based life skills and health empowerment program called TARANG for young, married women in Rajasthan, India. The study aims to compare the TARANG intervention with standard health information to see if it reduces unintended pregnancies and increases contraceptive use. This cluster randomized trial focuses on women aged 18 to 25 years who have recently married and moved into their husbands' homes. The TARANG intervention includes 14 group sessions led by trained moderators covering relationship navigation, sexual and reproductive health awareness, challenging gender norms, and life skills to improve decision-making and social mobility. Additional sessions include four light-touch meetings for mothers-in-law and one in-person session plus ongoing WhatsApp content for husbands. The control group will receive the standard health information. The intervention is designed to empower women and their families to reduce unintended pregnancies. Participants will be assessed on rates of unintended pregnancy and modern contraceptive use at 6 and 18 months after enrollment. Researchers will collect information through surveys and monitor participants' reproductive behaviors. Households will be recruited door-to-door, and follow-up will ensure the study tracks outcomes over time. The study seeks to understand if the TARANG program can delay pregnancy and support family planning among newly married women.

Researchers are evaluating the safety and effectiveness of LY4268989 compared to a placebo in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on participants who have had UC for at least 3 months and have specific disease activity scores. The study aims to understand how well LY4268989 works in treating this condition over a long period. Participants will receive either LY4268989 or a placebo, both administered orally. The study includes a treatment period lasting up to approximately 108 weeks, not including the screening phase. Participants are monitored to assess their response to the medication, including whether they achieve clinical remission based on the Modified Mayo Score (mMS). During the study, researchers will conduct various assessments to monitor disease activity and participant safety. They will track the percentage of participants achieving clinical remission at Week 10 and among those who responded at Week 10, the remission status at Week 52. The study involves regular evaluations, including endoscopic confirmation of disease activity and safety monitoring over the entire duration.

Researchers are investigating whether olomorasib combined with pembrolizumab is more effective than pembrolizumab plus placebo for participants with resected KRAS G12C-mutant non-small cell lung cancer (NSCLC) in part A. In part B, they are assessing if olomorasib combined with durvalumab is more effective than durvalumab plus placebo for participants with unresectable KRAS G12C-mutant NSCLC. This Phase 3 study may last up to 3 years for each participant.

Researchers are investigating oral squamous cell carcinoma, particularly cases with advanced nodal disease (N2-N3), to determine the benefit of adding induction chemotherapy before surgery. This phase 3, multicenter, randomized controlled trial focuses on patients with operable oral cancer presenting at an advanced stage, aiming to improve disease-free survival and overall outcomes by better selecting patients likely to respond to treatment. The study addresses limitations of earlier trials that included heterogeneous patient groups and stages, which may have affected results. Participants are randomly assigned to one of two treatment groups: the standard arm receives surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, while the experimental arm receives two cycles of TPF or TPX induction chemotherapy before surgery, then the same adjuvant treatment. The chemotherapy regimens include docetaxel, cisplatin, and 5-fluorouracil or capecitabine, administered in specific dosing schedules over a three-week cycle. Patients showing disease progression but still resectable may proceed to surgery, while others may receive alternative treatments. During the study, participants will be monitored for disease-free survival over two years, with further follow-up extending to five years. Researchers will also evaluate overall survival, treatment response rates, toxicity, compliance, postoperative complications, and quality of life. Tissue samples from oral cancer will be collected for future research. The study aims to enroll 346 patients aged 18 to 75 with adequate organ function and performance status, assessing the impact of induction chemotherapy on long-term outcomes.