[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658066":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":48,"studyPopulation":41,"armGroups":49,"interventions":60,"overallOfficials":82,"centralContacts":87,"locations":41,"responsibleParty":96,"collaborators":41,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":41,"studyType":112,"phases":113,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":122,"whyStopped":41,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":41},{"fullName":5,"class":6},"Genfleet Therapeutics (Shanghai) Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":41},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events","The incidence of DLT events","First 21 days",{"measure":14,"description":15,"timeFrame":16},"Phase II:Objective Response Rate (ORR)","Assessed by investigators according to RECIST 1.1","From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months",{"measure":18,"description":19,"timeFrame":20},"Phase Ib:Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)","The incidence and severity of AEs and SAEs，according to NCI CTCAE，v6.0","From the first dose until 30 days after the last dose, assessed up to 36 months",[22,25,28,31,34,38],{"measure":23,"description":24,"timeFrame":16},"DCR","Disease Control Rate (DCR)",{"measure":26,"description":27,"timeFrame":16},"DoR","Duration of Response assessed by investigators",{"measure":29,"description":30,"timeFrame":16},"TTR","Time To Response assessed by investigators",{"measure":32,"description":33,"timeFrame":16},"PFS","Progression-Free Survival (PFS) per Response Evaluation Criteria according to RECIST 1.1, as Determined by investigators",{"measure":35,"description":36,"timeFrame":37},"OS","Overall Survival","From the first dose until date of death from any cause, assessed up to 36 months",{"measure":39,"description":40,"timeFrame":20},"Phase II: Incidence and Severity of AE and SAE","Incidence and Severity of AE and SAE，Assessed according to CTCAE 6.0",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"NA","SINGLE_GROUP","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE","This open-label, multicenter Phase Ib\u002FII study enrolls participants with locally advanced or metastatic non-squamous NSCLC with RAS mutation or KRAS amplification, who have not received prior systemic anti-cancer therapy for advanced disease.\n\nIn Phase Ib, dose escalation of GFH276 will be performed in assigned arm to identify the recommended Phase 2 dose (RP2D) based on dose-limiting toxicity (DLT) and the overall safety profile. After RP2D determination, participants will be enrolled in Phase II to further evaluate the anti-tumor efficacy and long-term safety of each combination regimen. Study-related assessments will include tumor imaging, laboratory tests, adverse event monitoring, and pharmacokinetic sampling throughout the treatment period.\n\nParticipants will continue their assigned study treatment until confirmed disease progression, intolerable toxicity, withdrawal of consent, or study closure.",[50],{"label":51,"type":52,"description":53,"interventionNames":54},"GFH276 ±Tislelizumab + AP","EXPERIMENTAL","GFH276 once daily; Tislelizumab 200 mg, IV; AP: Pemetrexed 500 mg\u002Fm², IV; Cisplatin\u002FCarboplatin 75 mg\u002Fm²\u002FAUC=5, IV, every 3 weeks",[55,56,57,58,59],"Drug: GFH276","Drug: with or without Tislelizumab","Drug: Pemetrexed","Drug: Cisplatin","Drug: Carboplatin",[61,66,70,74,78],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":41},"DRUG","GFH276","Oral GFH276, administered at specified dose on schedule.",[51],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":41},"with or without Tislelizumab","Tislelizumab 200 mg, intravenous infusion, once every 3 weeks.or without Tislelizumab",[51],{"type":62,"name":71,"description":72,"armGroupLabels":73,"otherNames":41},"Pemetrexed","Pemetrexed 500 mg\u002Fm², intravenous infusion, once every 3 weeks.",[51],{"type":62,"name":75,"description":76,"armGroupLabels":77,"otherNames":41},"Cisplatin","Cisplatin 75 mg\u002Fm², intravenous infusion, once every 3 weeks.",[51],{"type":62,"name":79,"description":80,"armGroupLabels":81,"otherNames":41},"Carboplatin","Carboplatin at AUC=5, intravenous infusion, once every 3 weeks.",[51],[83],{"name":84,"affiliation":85,"role":86},"Ziming Li, MD","Shanghai Chest Hospital","PRINCIPAL_INVESTIGATOR",[88,93],{"name":89,"role":90,"phone":91,"phoneExt":41,"email":92},"Li Bai","CONTACT","+86 2168821388","lbai@genfleet.com",{"name":94,"role":90,"phone":91,"phoneExt":41,"email":95},"Pingping Zhang","ppzhang@genfleet.com",{"type":97,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100658066","phase-1-this-is-a-multicenter-open-label-phase-iii-study-to-explore-the-safety-tolerability-pharmacokinetics-pk-and-preliminary-efficacy-of-gfh276-in-patients-with-advanced-nsclc-harboring-a-ras-mutation-100658066",false,"NCT07846358","This is a Multicenter, Open-label, Phase I\u002FII Study to Explore the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of GFH276 in Patients With Advanced NSCLC Harboring a RAS Mutation.","A Phase Ib\u002FII, Multicenter, Open-Label Study To Evaluate Safety, Efficacy And Pharmacokinetics Of GFH276 In Combination With Tislelizumab, Pemetrexed And Platinum (Carboplatin Or Cisplatin) As First-Line Therapy In Participants With Locally Advanced Or Metastatic Non-Squamous Non-Small-Cell Lung Cancer Harboring RAS Mutation","GFH276X1203","Inclusion Criteria:\n\n1. Histologically\u002Fcytologically confirmed locally advanced or metastatic non squamous NSCLC (AJCC 8th edition Stage IIIB-IV).\n2. Confirmed RAS mutation or KRAS amplification；tumor cell PD L1 test report available\n3. No prior systemic anti-tumor therapy for advanced disease\n4. At least 1 measurable lesion outside the central nervous system (CNS) per RECIST v1.1\n5. ECOG performance status 0 or 1\n6. Life expectancy\\>3 months\n7. Willing to provide written informed consent\n8. Fertile participants must use effective contraception\n9. Adequate organ function\n\nExclusion Criteria:\n\n1. Other active malignancy within 3 years\n2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor\n3. History of active clinically significant cardiovascular dysfunction\n4. Known to harbor other targetable driver gene alterations\n5. Presence of active infection (HIV, HBV, HCV,)\n6. Prior anti-tumor therapy within 28 days or 5 half-lives\n7. Diagnosis of unstable thrombotic events requiring therapeutic intervention within 3 months prior to the first dose of study treatment.\n8. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.\n9. History of central nervous system (CNS)disease\n10. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.\n11. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.\n12. Active autoimmune disease requiring systemic treatment.","ALL","18 Years","75 Years",{"count":110,"type":111},84,"ESTIMATED","INTERVENTIONAL",[114,115],"PHASE1","PHASE2","This is an open-label, multicenter Phase Ib\u002FII clinical study evaluating GFH276 in combination with tislelizumab plus pemetrexed\u002Fplatinum based regimen as first-line therapy in participants with locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) harboring RAS mutation or KRAS amplification.",[118,119],"RAS Mutation","Non-small Cell Lung Cancer (NSCLC)",[63,118,121],"Non-small cell lung cancer (NSCLC)","NOT_YET_RECRUITING","2026-09-22",{"date":125,"type":126},"2026-09-29","ACTUAL",{"date":128,"type":111},"2026-11",{"date":130,"type":111},"2028-12",{"name":5,"class":6}]