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Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the efficacy and safety of combining ficlatuzumab with cetuximab compared to cetuximab alone in people with recurrent or metastatic RM HPV-negative head and neck squamous cell carcinoma HNSCC. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants who have not responded to prior anti-PD-1PD-L1 immune checkpoint inhibitors and platinum-based chemotherapy. The goal is to see if adding ficlatuzumab improves survival outcomes in this patient group. Participants are assigned to one of three groups two groups receive different doses of intravenous ficlatuzumab plus cetuximab on days 1 and 15 of each 28-day cycle, while the third group receives a placebo plus cetuximab on the same schedule. The study will enroll about 410 participants and compare progression-free survival and overall survival among these groups. Treatment cycles continue until disease progression or other study endpoints. During the study, participants will undergo regular imaging scans CT or MRI to assess tumor response every 8 weeks during the first year, then every 12 weeks in years 2 and 3, and every 6 months thereafter. Researchers will monitor safety, quality of life, and immune responses, including antidrug antibodies. The study period spans approximately 44 months with ongoing evaluations from randomization until death or last response assessment.

Researchers are evaluating Risvutatug Rezetecan Ris-Rez, a new medicine targeting specific proteins on cancer cells, in adults with relapsed extensive-stage small cell lung cancer ES-SCLC. This phase 3 study aims to compare how well Ris-Rez works versus the standard treatment, topotecan, by measuring cancer shrinkage, disappearance, and overall survival. The study also monitors safety, side effects, and tolerability of both treatments. Participants will be randomly assigned to receive either Ris-Rez or topotecan. Both treatments will be administered as part of the study to assess their effects. The study will follow participants for up to approximately 139 weeks to evaluate multiple outcomes including survival, tumor response, disease progression, and brain metastasis control. During the study, participants will have regular evaluations including scans, laboratory tests, vital signs, electrocardiograms, and performance status assessments. Researchers will track adverse events, laboratory changes, and participant experiences with the study drugs. The main outcome measured is overall survival up to about 113 weeks, with additional long-term monitoring of other health and disease measures throughout the study.

Researchers are evaluating zolbetuximab combined with pembrolizumab and chemotherapy in adults with stomach or gastroesophageal junction GEJ cancer. This study focuses on cancers that do not have the HER2 protein but do express Claudin 18.2. The goal is to understand how well zolbetuximab works with pembrolizumab and chemotherapy compared to a placebo with pembrolizumab and chemotherapy in people with advanced or metastatic disease that cannot be removed by surgery or has spread to other parts of the body. Participants will be randomly assigned to receive either zolbetuximab or a placebo, both given via intravenous infusion every 2 or 3 weeks, alongside pembrolizumab infusions every 3 or 6 weeks. Chemotherapy will be administered using one of two regimens, CAPOX or modified FOLFOX6, over multiple cycles lasting about 42 days each. Treatment continues until the cancer worsens, side effects prevent further use, or another therapy is needed. Pembrolizumab may be given for up to 2 years. During the study, participants will visit the clinic for infusions and health monitoring, including scans to check cancer status. Medical problems and treatment side effects will be recorded. After treatment ends, participants will continue to have regular health checks and scans every 9 to 12 weeks, along with phone check-ins every 3 months. The study will measure overall survival, disease progression, response rates, and safety over several years, with up to 72 months of follow-up for some outcomes.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.