A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
RecruitingResearchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereAurora, Colorado, United States + 47 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
RecruitingMulticenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).
PhasePhase 3
TypeInterventional
Age18 Years
WhereBeverly Hills, California, United States + 206 more
SponsorOSE Immunotherapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT06667076 · Carcinoma, Non-Small-Cell Lung
RecruitingThe primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).
PhasePhase 2
TypeInterventional
Age18 Years
WhereDaphne, Alabama, United States + 200 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Small Cell Lung Cancer Community Engagement to Eliminate Research Discepancies
RecruitingThis study will evaluate if a direct-to-patient, de-centralized, remote approach will improve clinical research outreach and engagement for patients with SCLC, in the context of a bio-specimen collection study. The study will also assess self-reported preferences and needs of patients with SCLC, regarding choosing and accessing novel therapies in research or standard clinical care settings and supportive gaps in this area, through an initial and 3 month follow up survey.
Phase—
TypeObservational
Age18 Years
WhereMultiple Locations, Alabama, United States + 51 more
SponsorAddario Lung Cancer Medical Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 52 more
SponsorIambic Therapeutics, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
NCT06465069 · Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor
RecruitingThe purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 32 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
NCT05150691 · HER2-positive Advanced Solid Tumor
RecruitingThis is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereCerritos, California, United States + 101 more
SponsorDualityBio Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer
RecruitingThe study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WhereSt. Petersburg, Florida, United States + 23 more
SponsorMerus B.V.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
NCT06051695 · Solid Tumor, Adult,
Colorectal Cancer, NSCLC
RecruitingThe goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose that is safe for patients Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: Enrollment and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen Tmod CAR T cells at the assigned dose
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 11 more
SponsorA2 Biotherapeutics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereOrange, California, United States + 20 more
SponsorTaiho Pharmaceutical Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
NCT03452774 · Cancer, Metastatic,
Cancer, Cancer of Pancreas
RecruitingInternational registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention.
Phase—
TypeObservational
AgeAny
WhereBirmingham, Alabama, United States + 67 more
SponsorMassive Bio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
NCT07109726 ·
Breast Cancer, Endometrial Cancer,
Ovarian Cancer RecruitingThis is a Phase 1/2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT/PI3K/PTEN pathway alterations.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereOrlando, Florida, United States + 14 more
SponsorTerremoto Biosciences Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In
NCT06745908 · NSCLC Stage IV
RecruitingThis is a randomized, two-cohort, open-label, phase 3, clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (cohort A) or prior failed Health Authority-approved antiprogrammed death-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) CPI and docetaxel (cohort B) versus docetaxel monotherapy (cohorts A and B). For each cohort, enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. For cohort A, the randomization will be stratified by geographical region (North America vs Europe vs Asia vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (epidermal growth factor receptor \[EGFR\]/anaplastic lymphoma kinase \[ALK\]/ROS proto-oncogene 1, receptor tyrosine kinase \[ROS1\] vs Other AGA vs No AGA). For cohort B, the randomization will be stratified by geographical region (Americas vs Asia Pacific \[PAC\] vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (Yes vs No).
PhasePhase 3
TypeInterventional
Age18 Years – 90 Years
WhereSpringdale, Arkansas, United States + 18 more
SponsorImmunityBio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
NCT07217171 · Bladder Cancer, Squamous Cell Carcinoma of the Lung, Esophageal Squamous Cell Carcinoma
RecruitingThe goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 9 more
SponsorEvolveImmune United, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
NCT06500455 ·
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Digestive System Carcinoma
RecruitingThis phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
PhasePhase 3
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 262 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
RecruitingA first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 34 more
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
RecruitingFirst in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 35 more
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
RecruitingThe objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBeverly Hills, California, United States + 38 more
SponsorSystImmune Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
RecruitingThis is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations,uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). Patients will be enrolled and dosed according to the most current protocol. This study is made of two Parts. Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations, or uncommon mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations, classical mutations, or uncommon mutations.
PhasePhase 1
TypeInterventional
Age18 Years
WhereSacramento, California, United States + 6 more
SponsorAvistone Biotechnology Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)
RecruitingResearchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.
PhasePhase 2
TypeInterventional
Age18 Years
WhereTampa, Florida, United States + 46 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts