[ { "adult": true, "allocation": [ "Randomized" ], "blinding": [ "Open label" ], "combination_therapy": true, "completion_date": "2029-12-01", "control": true, "crossover": false, "description": "A Phase 3, randomized, open-label study comparing the efficacy and safety of ifinatamab deruxtecan (I-DXd) versus treatment of physician's choice in participants with relapsed extensive-stage small cell lung cancer (SCLC).", "design_diagram": { "arms": [ { "arm_id": "arm_1", "description": "12 mg/kg IV Q3W", "name": "Ifinatamab deruxtecan (I-DXd)" }, { "arm_id": "arm_2", "description": "Topotecan, amrubicin, or lurbinectedin per local SoC", "name": "Treatment of Physician's Choice (TPC)" } ], "blocks": [ { "arms": [ "arm_1", "arm_2" ], "details": "Participants randomized to receive either I-DXd or Treatment of Physician's Choice", "end_week": 0, "name": "Randomization", "start_week": 0, "type": "randomization" }, { "arms": [ "arm_1" ], "details": "Ifinatamab deruxtecan 12 mg/kg IV on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity", "end_week": 192, "name": "Treatment Period", "start_week": 0, "type": "treatment" }, { "arms": [ "arm_2" ], "details": "Treatment of Physician's Choice (topotecan, amrubicin, or lurbinectedin) per local standard-of-care until disease progression or unacceptable toxicity", "end_week": 192, "name": "Treatment Period", "start_week": 0, "type": "treatment" } ] }, "disease_class_ids": [ "GD-01", "GD-01-03", "GD-01-03-02", "GD-01-03-02-02", "GD-13", "GD-13-11" ], "disease_ids": [ "6808091ac55176ca19a41b36" ], "disease_ontology_version": "v4", "diseases": [ "small cell lung cancer (SCLC)" ], "double_blind": false, "drug": [ "ifinatamab deruxtecan" ], "drug_effect": "Disease-modifying therapy", "eligibility": { "age": { "min": 18 }, "cardiovascular_disease_exclusion": true, "comment": "Participants must have a chemotherapy-free interval of >=30 days and at least 1 measurable lesion according to RECIST v1.1.", "corneal_disease_exclusion": true, "disease_progression_required": true, "ecog": { "max": 1, "min": 0 }, "eligibility_summary": "Adults with relapsed extensive-stage small cell lung cancer who have received exactly one prior platinum-based line of therapy, with ECOG PS 0-1, excluding those with prior B7-H3 targeted agents, topoisomerase I inhibitors, or history of interstitial lung disease.", "exclusion_prior_therapies": [ "orlotamab", "enoblituzumab", "B7-H3 targeted agents", "topoisomerase I inhibitor", "topotecan", "amrubicin", "lurbinectedin" ], "exclusion_prior_topoisomerase_inhibitor": true, "gender": "Both", "interstitial_lung_disease_exclusion": true, "primary_diagnosis": "extensive-stage small cell lung cancer", "prior_lines_therapy": 1 }, "first_posted": "2024-01-12", "has_comparator": true, "has_designations": true, "has_results": false, "has_success_data": false, "industry_collaborators": true, "last_updated": "2026-08-06", "lead_sponsor": false, "line_of_treatment": [ "subsequent" ], "main_drug_id": [ "67c1af9cd5adeadf28e3a787" ], "moa": [ "antagonist" ], "modalities": [ "Monoclonal Antibodies", "Antibody-Drug Conjugates (ADCs)", "Small Molecules" ], "modality_class_ids": [ "GM-04020000", "GM-04000000", "GM-01000000", "GM-04020100", "GM-04020110", "GM-04010000" ], "multi_arm": false, "nct_id": "NCT06203210", "official_status": "Recruiting", "open_label": true, "pharmacokinetics": true, "phase": "3", "placebo": false, "primary_completion_date": "2028-01-30", "primary_endpoints": [ "Overall Survival (OS)" ], "randomized": true, "registry": "ctg", "sponsor_ids": [ "666c7d93999fb54d484e3a0d" ], "sponsors": [ "Daiichi Sankyo Co., Ltd." ], "start_date": "2024-05-21", "status": "Active", "status_verified_date": "2026-08", "study_code": "IDeate-Lung02", "target_class_ids": [ "GT-54", "GT-54-22" ], "target_ids": [ "675b7470df06b1e6c720945f", "680389902c09a077cc7ec38a" ], "targets": [ "B7-H3" ], "therapy_type": "targeted", "title": "Ifinatamab Deruxtecan (I-DXd) vs Treatment of Physician's Choice in Relapsed Small Cell Lung Cancer", "trial_id": "NCT06203210" }, { "administration_setting": "outpatient", "adult": true, "allocation": [ "Randomized" ], "blinding": [ "Open label" ], "combination_therapy": false, "completion_date": "2027-05-31", "control": true, "crossover": false, "description": "A Phase 3, randomized, open-label study comparing the efficacy and safety of the B7-H3-targeted ADC HS-20093 versus topotecan in patients with relapsed small cell lung cancer (SCLC) who have progressed on or after first-line platinum-based chemotherapy.", "design_diagram": { "$schema": "http://json-schema.org/draft-07/schema#", "arms": [ { "arm_id": "Arm_1", "description": "HS-20093 8.0 mg/kg IV Q3W", "name": "HS-20093" }, { "arm_id": "Arm_2", "description": "Topotecan SOC", "name": "Topotecan" } ], "blocks": [ { "arms": [ "Arm_1", "Arm_2" ], "details": "Screening for eligibility including measurable lesions and recovery from prior toxicity.", "end_week": 0, "name": "Screening", "start_week": -4, "type": "screening" }, { "arms": [ "Arm_1", "Arm_2" ], "details": "1:1 Randomization", "end_week": 0, "name": "Randomization", "start_week": 0, "type": "randomization" }, { "arms": [ "Arm_1" ], "details": "HS-20093 8.0 mg/kg IV on Day 1 of each 21-day cycle until progression.", "end_week": 234, "name": "Treatment Phase", "start_week": 0, "type": "treatment" }, { "arms": [ "Arm_2" ], "details": "Topotecan administered per drug label until progression.", "end_week": 234, "name": "Treatment Phase", "start_week": 0, "type": "treatment" }, { "arms": [ "Arm_1", "Arm_2" ], "details": "Follow-up for Overall Survival up to approximately 4.5 years.", "end_week": 234, "name": "Survival Follow-up", "start_week": 234, "type": "follow_up" } ], "title": "Clinical Trial Design Schema", "type": "object" }, "disease_class_ids": [ "GD-01", "GD-01-03", "GD-01-03-02", "GD-13", "GD-13-11" ], "disease_ids": [ "6808091ac55176ca19a41b36" ], "disease_ontology_version": "v4", "diseases": [ "small cell lung cancer (SCLC)" ], "double_blind": false, "drug": [ "risvutatug rezetecan" ], "drug_effect": "Disease-modifying therapy", "eligibility": { "active_infection": false, "age": { "min": 18 }, "biomarkers": [], "comment": "Excludes patients with a chemotherapy-free interval <= 30 days.", "contraception": true, "contraception_required": true, "ecog": { "max": 1, "min": 0 }, "eligibility_summary": "Patients with histologically or cytologically confirmed limited or extensive SCLC who have progressed on or after first-line platinum-based regimens, have an ECOG PS of 0-1, and have not received prior B7-H3 targeted agents or topoisomerase I inhibitors.", "ethnicities": [], "exclusion_mutations": [], "exclusion_prior_therapies": [ "anti-B7 homologue 3 (B7-H3) targeted agents", "topoisomerase I inhibitor", "ADC that consists of topoisomerase I inhibitor" ], "gender": "Both", "healthy_otherwise": false, "healthy_volunteers": false, "inclusion_mutations": [], "life_expectancy": { "max": null, "min": 0.23 }, "liver_disease_exclusion": false, "malignancy_history": true, "medications": [], "pregnancy_exclusion": true, "prior_therapies": [ "platinum-based regimen" ], "recovery_from_prior_therapy_toxicity": false, "washout_period": 4 }, "first_posted": "2024-07-12", "has_comparator": true, "has_designations": true, "has_results": false, "has_success_data": false, "industry_collaborators": true, "inpatient": false, "last_updated": "2024-10-16", "lead_sponsor": false, "line_of_treatment": [ "subsequent" ], "main_drug_id": [ "693f4d75d91942c1924b64bd" ], "moa": [ "blocker", "antagonist" ], "modalities": [ "Antibody-Drug Conjugates (ADCs)" ], "modality_class_ids": [ "GM-04000000", "GM-04020000", "GM-04020110", "GM-04020100" ], "multi_arm": false, "nct_id": "NCT06498479", "official_status": "Recruiting", "open_label": true, "pharmacokinetics": true, "phase": "3", "placebo": false, "primary_completion_date": "2026-09-30", "primary_endpoints": [ "Overall survival" ], "randomized": true, "registry": "ctg", "run_in_period": false, "sponsor_ids": [ "666c7e7d999fb54d484e3e6c" ], "sponsors": [ "Hansoh Pharmaceutical Group" ], "start_date": "2024-07-04", "status": "Active", "status_verified_date": "2024-10", "target_class_ids": [ "GT-27-01", "GT-27", "GT-54", "GT-54-22" ], "target_ids": [ "680389902c09a077cc7ebcec", "675b725a3870252f399a54d5", "680389902c09a077cc7eda7a" ], "targets": [ "TOP1", "B7-H3" ], "therapy_type": "targeted", "title": "HS-20093 vs Topotecan in Relapsed Small Cell Lung Cancer", "trial_id": "NCT06498479", "washout": true }, { "administration_setting": "outpatient", "adult": true, "allocation": [ "Randomized" ], "blinding": [ "Open label" ], "combination_therapy": false, "completion_date": "2029-01-31", "control": true, "crossover": false, "description": "A Phase 3 study evaluating HS-20093 as consolidation therapy compared to active surveillance in patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy.", "design_diagram": { "$schema": "http://json-schema.org/draft-07/schema#", "arms": [ { "arm_id": "1", "description": "HS-20093 8.0 mg/kg IV Q3W", "name": "HS-20093" }, { "arm_id": "2", "description": "No active drug intervention", "name": "Active Surveillance" } ], "blocks": [ { "arms": [ "1", "2" ], "details": "Eligibility assessment", "end_week": 0, "name": "Screening", "start_week": 0, "type": "screening" }, { "arms": [ "1", "2" ], "details": "Randomized allocation", "end_week": 0, "name": "Randomization", "start_week": 0, "type": "randomization" }, { "arms": [ "1" ], "details": "HS-20093 8.0 mg/kg IV Q3W until progression/toxicity", "end_week": null, "name": "Treatment Phase", "start_week": 1, "type": "treatment" }, { "arms": [ "2" ], "details": "Active surveillance until progression", "end_week": null, "name": "Active Surveillance", "start_week": 1, "type": "treatment" } ], "title": "Clinical Trial Design Schema", "type": "object" }, "disease_class_ids": [ "GD-01", "GD-01-03", "GD-01-03-02", "GD-01-03-02-01", "GD-13", "GD-13-11" ], "disease_ids": [ "6808091ac55176ca19a41b36" ], "disease_ontology_version": "v4", "diseases": [ "small cell lung cancer (SCLC)" ], "double_blind": false, "drug": [ "risvutatug rezetecan" ], "drug_effect": "Disease-modifying therapy", "eligibility": { "active_infection": false, "age": { "min": 18 }, "biomarkers": [], "chronic": false, "comment": "Excludes patients with mixed SCLC/NSCLC or large cell neuroendocrine carcinoma.", "contraception": true, "disease_progression_required": false, "ecog": { "max": 1, "min": 0 }, "eligibility_summary": "Adult patients with limited-stage small cell lung cancer (LS-SCLC) who have not progressed after chemoradiotherapy, have ECOG PS 0-1, and no prior B7-H3 targeted therapy.", "ethnicities": [], "exclusion_mutations": [], "exclusion_other_malignancies": true, "exclusion_prior_therapies": [ "B7-H3 target therapy", "Traditional Chinese medicine" ], "gender": "Both", "healthy_otherwise": false, "healthy_volunteers": false, "histology": [ "small cell lung cancer" ], "inclusion_mutations": [], "life_expectancy": { "min": 0.23 }, "medications": [], "pregnancy_exclusion": true, "prior_therapies": [ "chemoradiotherapy" ], "recovery_from_prior_therapy_toxicity": true, "severe_bleeding": false, "severe_thrombosis": false }, "first_posted": "2024-07-30", "has_comparator": true, "has_designations": true, "has_results": false, "has_success_data": false, "industry_collaborators": true, "inpatient": false, "last_updated": "2024-07-30", "lead_sponsor": false, "line_of_treatment": [ "subsequent" ], "main_drug_id": [ "693f4d75d91942c1924b64bd" ], "moa": [ "blocker", "antagonist" ], "modalities": [ "Antibody-Drug Conjugates (ADCs)" ], "modality_class_ids": [ "GM-04000000", "GM-04020000", "GM-04020110", "GM-04020100" ], "multi_arm": false, "nct_id": "NCT06526624", "official_status": "Not yet recruiting", "open_label": true, "pharmacokinetics": false, "phase": "3", "placebo": false, "primary_completion_date": "2027-11-30", "primary_endpoints": [ "Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC)", "Overall survival (OS)" ], "randomized": true, "registry": "ctg", "run_in_period": false, "sponsor_ids": [ "666c7e7d999fb54d484e3e6c" ], "sponsors": [ "Hansoh Pharmaceutical Group" ], "start_date": "2024-09-30", "status": "Active", "status_verified_date": "2024-07", "target_class_ids": [ "GT-27-01", "GT-27", "GT-54", "GT-54-22" ], "target_ids": [ "680389902c09a077cc7ebcec", "675b725a3870252f399a54d5", "680389902c09a077cc7eda7a" ], "targets": [ "TOP1", "B7-H3" ], "therapy_type": "targeted", "title": "HS-20093 vs Active Surveillance in LS-SCLC", "trial_id": "NCT06526624", "washout": false }, { "adult": true, "allocation": [ "Randomized" ], "biomarkers": [ "B7-H3" ], "blinding": [ "Open label" ], "combination_therapy": false, "completion_date": "2030-12-01", "control": true, "crossover": false, "description": "A Phase III study comparing the efficacy and safety of YL201 versus topotecan hydrochloride in subjects with relapsed small cell lung cancer.", "design_diagram": { "arms": [ { "arm_id": "arm_1", "description": "YL201 monotherapy intravenously on Day 1 of each 3-week cycle", "name": "YL201" }, { "arm_id": "arm_2", "description": "Topotecan hydrochloride intravenously, on Days 1 to 5 of each 3-week cycle", "name": "topotecan hydrochloride for injection" } ], "blocks": [ { "arms": [ "arm_1", "arm_2" ], "details": "YL201 IV Q3W vs Topotecan IV Days 1-5 Q3W until PD, unacceptable toxicity, or withdrawal.", "end_week": 156, "name": "Treatment Period", "start_week": 0, "type": "treatment" } ] }, "disease_class_ids": [ "GD-01", "GD-01-03", "GD-01-03-02", "GD-13", "GD-13-11" ], "disease_ids": [ "6808091ac55176ca19a41b36" ], "disease_ontology_version": "v4", "diseases": [ "small cell lung cancer (SCLC)" ], "double_blind": false, "drug": [ "YL201" ], "drug_effect": "Disease-modifying therapy", "eligibility": { "active_infection": false, "age": { "max": 75, "min": 18 }, "biomarkers": [ "B7-H3" ], "comment": "Subjects must be willing to provide tumor tissue for detection of B7-H3 expression.", "ecog": { "max": 1, "min": 0 }, "eligibility_summary": "Adults 18-75 with relapsed SCLC after first-line platinum-based therapy, ECOG PS 0-1, life expectancy >= 3 months, adequate organ function. Excludes prior B7-H3 targeted therapy, prior topoisomerase I inhibitors, active CNS metastases, and active HBV/HCV.", "exclusion_other_malignancies": true, "exclusion_prior_therapies": [ "B7-H3-targeted therapy", "topoisomerase I inhibitor", "ADC consisting of a topoisomerase I inhibitor" ], "exclusion_prior_topoisomerase_inhibitor": true, "gender": "Both", "hcv": false, "life_expectancy": { "min": 0.25 }, "pregnancy_exclusion": true, "prior_lines_therapy": 1, "prior_therapies": [ "platinum-based therapy" ] }, "first_posted": "2024-09-25", "has_comparator": true, "has_designations": true, "has_results": false, "has_success_data": false, "industry_collaborators": true, "last_updated": "2026-09-02", "lead_sponsor": false, "line_of_treatment": [ "subsequent" ], "main_drug_id": [ "67f6ac683623f1d2313f644d" ], "moa": [ "antagonist" ], "modalities": [ "Small Molecules", "Antibody-Drug Conjugates (ADCs)", "Engineered Antibody Formats", "Monoclonal Antibodies" ], "modality_class_ids": [ "GM-04020000", "GM-04000000", "GM-01000000", "GM-04020100", "GM-04020110" ], "multi_arm": false, "nct_id": "NCT06612151", "official_status": "Active, not recruiting", "open_label": true, "pharmacokinetics": true, "phase": "3", "placebo": false, "primary_completion_date": "2027-12-01", "primary_endpoints": [ "To compare the OS of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC." ], "randomized": true, "registry": "ctg", "run_in_period": false, "sponsor_ids": [ "666c7f5b999fb54d484e43b4" ], "sponsors": [ "MediLink Therapeutics" ], "start_date": "2024-12-17", "status": "Active", "status_verified_date": "2026-05", "target_class_ids": [ "GT-27-01", "GT-27", "GT-54", "GT-54-22" ], "target_ids": [ "675b7470df06b1e6c720945f", "69d84f475e9db611712e00ea", "675b725a3870252f399a54d5" ], "targets": [ "TOP1", "B7-H3" ], "therapy_type": "targeted", "title": "YL201 vs Topotecan in Relapsed Small Cell Lung Cancer", "trial_id": "NCT06612151" }, { "administration_setting": "outpatient", "adult": true, "allocation": [ "Randomized" ], "blinding": [ "Open label" ], "combination_therapy": true, "completion_date": "2028-04", "control": true, "crossover": false, "description": "A Phase 3 randomized study comparing MHB088C (anti-B7-H3 ADC) versus physician's choice of chemotherapy in patients with relapsed extensive-stage small cell lung cancer.", "design_diagram": { "$schema": "http://json-schema.org/draft-07/schema#", "arms": [ { "arm_id": "arm1", "description": "MHB088C 2 mg/kg IV on D1, D15 q4w", "name": "MHB088C" }, { "arm_id": "arm2", "description": "Physician's Choice of Topotecan, Irinotecan, or Paclitaxel", "name": "TPC" } ], "blocks": [ { "arms": [ "arm1", "arm2" ], "details": "Assessment of eligibility criteria including imaging and lab tests.", "end_week": 4, "name": "Screening Period", "start_week": 0, "type": "screening" }, { "arms": [ "arm1", "arm2" ], "details": "Participants randomized to MHB088C or TPC.", "end_week": 4, "name": "Randomization", "start_week": 4, "type": "randomization" }, { "arms": [ "arm1" ], "details": "MHB088C 2 mg/kg IV on Day 1 and 15 of each 28-day cycle until progression/toxicity.", "end_week": null, "name": "Treatment Phase", "start_week": 4, "type": "treatment" }, { "arms": [ "arm2" ], "details": "TPC (Topotecan, Irinotecan, or Paclitaxel) per label until progression/toxicity.", "end_week": null, "name": "Treatment Phase", "start_week": 4, "type": "treatment" }, { "arms": [ "arm1", "arm2" ], "details": "Follow-up for survival up to approximately 5 years.", "end_week": null, "name": "Follow-up", "start_week": null, "type": "follow_up" } ], "title": "Clinical Trial Design Schema", "type": "object" }, "disease_class_ids": [ "GD-01", "GD-01-03", "GD-01-03-02", "GD-01-03-02-02", "GD-13", "GD-13-11" ], "disease_ids": [ "6808091ac55176ca19a41b36" ], "disease_ontology_version": "v4", "diseases": [ "small cell lung cancer (SCLC)" ], "double_blind": false, "drug": [ "MHB088C" ], "drug_effect": "Disease-modifying therapy", "eligibility": { "active_infection": false, "age": { "min": "18 years" }, "contraception_required": true, "ecog": { "max": 1, "min": 0 }, "eligibility_summary": "Adults with relapsed extensive-stage SCLC who have progressed after platinum-based and PD-1/L1 therapy (max 2 prior lines). Excludes patients with prior topo I inhibitor treatment, symptomatic brain metastases, or severe pulmonary disease.", "exclusion_other_malignancies": true, "exclusion_prior_topoisomerase_inhibitor": true, "exclusion_therapies": [ "prior B7-H3-targeted therapy" ], "gender": "Both", "histology": [ "small cell lung cancer" ], "life_expectancy": { "min": 0.25 }, "liver_disease_exclusion": false, "pregnancy_exclusion": true, "prior_lines_therapy": 1, "prior_therapies": [ "platinum-based therapy", "PD-1/L1 systemic therapy" ], "washout_period": 4 }, "first_posted": "2025-05-01", "has_comparator": true, "has_designations": false, "has_results": false, "has_success_data": false, "industry_collaborators": true, "inpatient": false, "last_updated": "2025-06-18", "lead_sponsor": false, "line_of_treatment": [ "subsequent" ], "main_drug_id": [ "67f826b54afab6023b2ab93d" ], "moa": [ "antagonist" ], "modalities": [ "Monoclonal Antibodies", "Antibody-Drug Conjugates (ADCs)", "Small Molecules" ], "modality_class_ids": [ "GM-04020000", "GM-04000000", "GM-01000000", "GM-04020100", "GM-04020110", "GM-04010000" ], "multi_arm": false, "nct_id": "NCT06954246", "official_status": "Recruiting", "open_label": true, "pharmacokinetics": true, "phase": "3", "placebo": false, "primary_completion_date": "2027-05", "primary_endpoints": [ "Overall Survival" ], "randomized": true, "registry": "ctg", "run_in_period": false, "sponsor_ids": [ "666c8059999fb54d484e4a00" ], "sponsors": [ "Qilu Pharmaceutical" ], "start_date": "2025-06-04", "status": "Active", "status_verified_date": "2025-04", "target_class_ids": [ "GT-27-01", "GT-27", "GT-54", "GT-54-22" ], "target_ids": [ "675b7470df06b1e6c720945f", "680389902c09a077cc7ec3e8", "675b725a3870252f399a54d5" ], "targets": [ "TOP1", "B7-H3" ], "therapy_type": "targeted", "title": "MHB088C vs TPC in Relapsed SCLC", "trial_id": "NCT06954246", "washout": false }, { "adult": true, "allocation": [ "Randomized" ], "blinding": [ "Open label" ], "combination_therapy": false, "completion_date": "2029-09-28", "control": true, "crossover": false, "description": "Phase 3 study evaluating Risvutatug rezetecan (Ris-Rez) compared to topotecan in participants with relapsed small cell lung cancer (SCLC).", "design_diagram": { "arms": [ { "arm_id": "arm_1", "description": "Experimental arm receiving Risvutatug rezetecan", "name": "Ris-Rez" }, { "arm_id": "arm_2", "description": "Active comparator arm receiving Topotecan", "name": "Topotecan" } ], "blocks": [ { "arms": [ "arm_1", "arm_2" ], "details": "Participants receive either Ris-Rez or Topotecan until disease progression or unacceptable toxicity.", "end_week": 139, "name": "Treatment Period", "start_week": 0, "type": "treatment" } ] }, "disease_class_ids": [ "GD-01", "GD-01-03", "GD-01-03-02", "GD-01-03-02-02", "GD-13", "GD-13-11" ], "disease_ids": [ "6808091ac55176ca19a41b36" ], "disease_ontology_version": "v4", "diseases": [ "small cell lung cancer (SCLC)" ], "double_blind": false, "drug": [ "risvutatug rezetecan" ], "drug_effect": "Disease-modifying therapy", "eligibility": { "active_infection": false, "age": { "min": "18 years" }, "comment": "Excludes complex or transformed SCLC, limited stage SCLC at diagnosis, symptomatic brain metastases, interstitial lung disease, and significant pulmonary disease.", "disease_progression_required": true, "ecog": { "max": 1, "min": 0 }, "eligibility_summary": "Adults with extensive-stage small cell lung cancer who have progressed after 1 prior platinum-based systemic therapy with a PD-(L)1 inhibitor, excluding those with prior TOPO1-inhibitor ADC or B7-H3 targeted treatments.", "exclusion_hiv": true, "exclusion_prior_topoisomerase_inhibitor": true, "exclusion_therapies": [ "treatments targeting B7-H3" ], "gender": "Both", "hcv": false, "histology": [ "extensive-stage small cell lung cancer" ], "primary_diagnosis": "small cell lung cancer", "prior_lines_therapy": 1, "prior_therapies": [ "platinum-based systemic therapy", "PD-(L)1 inhibitor" ] }, "first_posted": "2025-08-01", "has_comparator": true, "has_designations": true, "has_results": false, "has_success_data": false, "industry_collaborators": true, "last_updated": "2026-08-31", "line_of_treatment": [ "subsequent" ], "main_drug_id": [ "693f4d75d91942c1924b64bd" ], "moa": [ "blocker", "antagonist" ], "modalities": [ "Antibody-Drug Conjugates (ADCs)" ], "modality_class_ids": [ "GM-04000000", "GM-04020000", "GM-04020110", "GM-04020100" ], "multi_arm": false, "nct_id": "NCT07099898", "official_status": "Recruiting", "open_label": true, "pharmacokinetics": true, "phase": "3", "placebo": false, "primary_completion_date": "2027-11-05", "primary_endpoints": [ "Overall Survival (OS)" ], "randomized": true, "registry": "ctg", "sponsor_ids": [ "666c7d00999fb54d484e372c" ], "sponsors": [ "GSK" ], "start_date": "2025-08-11", "status": "Active", "status_verified_date": "2026-08", "target_class_ids": [ "GT-27-01", "GT-27", "GT-54", "GT-54-22" ], "target_ids": [ "680389902c09a077cc7ebcec", "675b725a3870252f399a54d5", "680389902c09a077cc7eda7a" ], "targets": [ "TOP1", "B7-H3" ], "therapy_type": "targeted", "title": "Risvutatug rezetecan vs Topotecan in Relapsed SCLC", "trial_id": "NCT07099898" }, { "adult": true, "allocation": [ "Randomized" ], "blinding": [ "Open label" ], "combination_therapy": true, "completion_date": "2030-04", "control": true, "crossover": false, "description": "A Phase III study comparing YL201 + serplulimab versus carboplatin + etoposide + serplulimab as first-line treatment in patients with extensive-stage small cell lung cancer.", "design_diagram": { "$schema": "http://json-schema.org/draft-07/schema#", "arms": [ { "arm_id": "arm_1", "description": "YL201 2.0 mg/kg IV Q3W + Serplulimab 300mg IV Q3W", "name": "YL201 in combination with serplulimab" }, { "arm_id": "arm_2", "description": "Carboplatin AUC 5 IV Q3W + Etoposide 100 mg/m2 IV Q3W (4 cycles) + Serplulimab 300mg IV Q3W", "name": "Carboplatin and etoposide in combination with serplulimab" } ], "blocks": [ { "arms": [ "arm_1", "arm_2" ], "details": "Arm 1: YL201 + Serplulimab until progression/toxicity (Serplulimab max 2 years). Arm 2: Carboplatin + Etoposide + Serplulimab for 4 cycles, then Serplulimab maintenance up to 2 years.", "end_week": 104, "name": "Treatment Phase", "start_week": 0, "type": "treatment" } ], "title": "Clinical Trial Design Schema" }, "disease_class_ids": [ "GD-01", "GD-01-03", "GD-01-03-02", "GD-01-03-02-02", "GD-13", "GD-13-11" ], "disease_ids": [ "6808091ac55176ca19a41b36" ], "disease_ontology_version": "v4", "diseases": [ "small cell lung cancer (SCLC)" ], "double_blind": false, "drug": [ "YL201" ], "drug_effect": "Disease-modifying therapy", "eligibility": { "active_infection": false, "age": { "min": 18 }, "ecog": { "max": 1, "min": 0 }, "eligibility_summary": "Adults with treatment-naïve extensive-stage small cell lung cancer, ECOG 0-1, life expectancy >= 3 months, adequate organ function. Excludes active brain metastases, severe cardiovascular disease, ILD, active autoimmune disease, active infections (HIV, HBV, HCV, TB, syphilis), and history of other primary malignancies within 5 years.", "exclusion_hiv": true, "exclusion_other_malignancies": true, "gender": "Both", "hcv": false, "life_expectancy": { "min": 0.25 }, "pregnancy_exclusion": true, "primary_diagnosis": "extensive-stage small cell lung cancer", "prior_lines_therapy": 0 }, "first_posted": "2026-07-31", "has_comparator": true, "has_designations": true, "has_results": false, "has_success_data": false, "industry_collaborators": true, "last_updated": "2026-08-24", "lead_sponsor": false, "line_of_treatment": [ "first-line" ], "main_drug_id": [ "67f6ac683623f1d2313f644d" ], "moa": [ "antagonist" ], "modality_class_ids": [ "GM-04020000", "GM-04000000", "GM-01000000", "GM-04020100", "GM-04020110" ], "multi_arm": false, "nct_id": "NCT07739758", "official_status": "Recruiting", "open_label": true, "pharmacokinetics": true, "phase": "3", "placebo": false, "primary_completion_date": "2029-06", "primary_endpoints": [ "Overall survival (OS)", "Progression-free survival (PFS) as assessed by BIRC" ], "randomized": true, "registry": "ctg", "run_in_period": false, "sponsor_ids": [ "666c7f5b999fb54d484e43b4" ], "sponsors": [ "MediLink Therapeutics" ], "start_date": "2026-08-18", "status": "Active", "status_verified_date": "2026-08", "target_class_ids": [ "GT-27-01", "GT-27", "GT-54", "GT-54-22" ], "target_ids": [ "675b7470df06b1e6c720945f", "69d84f475e9db611712e00ea", "675b725a3870252f399a54d5" ], "therapy_type": "targeted", "title": "YL201 + Serplulimab vs Carboplatin + Etoposide + Serplulimab in 1L ES-SCLC", "trial_id": "NCT07739758", "washout": false }, { "adult": true, "allocation": [ "Randomized" ], "blinding": [ "Open label" ], "combination_therapy": true, "completion_date": "2030-06-15", "control": true, "crossover": false, "description": "A Phase III, randomized, open-label study comparing QLC5508 + QL2107 versus Tislelizumab + platinum-based chemotherapy as first-line treatment in participants with extensive-stage small cell lung cancer.", "design_diagram": { "arms": [ { "arm_id": "arm_1", "description": "QLC5508 IV Q3W + QL2107 IV Q3W", "name": "QLC5508 + QL2107" }, { "arm_id": "arm_2", "description": "Tislelizumab IV Q3W + Carboplatin/Cisplatin IV Q3W + Etoposide IV Q3W", "name": "Tislelizumab + Chemotherapy" } ], "blocks": [ { "arms": [ "arm_1", "arm_2" ], "details": "Treatment continues until disease progression, unacceptable toxicity, or up to 2 years (for QL2107 and Tislelizumab). Chemotherapy up to 4 cycles.", "end_week": 104, "name": "Treatment Period", "start_week": 0, "type": "treatment" } ] }, "disease_class_ids": [ "GD-01", "GD-01-03", "GD-01-03-02", "GD-01-03-02-02", "GD-13", "GD-13-11" ], "disease_ids": [ "6808091ac55176ca19a41b36" ], "disease_ontology_version": "v4", "diseases": [ "small cell lung cancer (SCLC)" ], "double_blind": false, "drug": [ "QLC5508", "QL2107" ], "drug_effect": "Disease-modifying therapy", "eligibility": { "active_infection": false, "age": { "min": 18 }, "comment": "Requires at least one extracranial measurable lesion according to RECIST v1.1.", "contraception_required": true, "ecog": { "max": 1, "min": 0 }, "eligibility_summary": "Adults with previously untreated extensive-stage small cell lung cancer, ECOG 0-1, adequate organ function, and measurable disease. Excludes patients with active brain metastases, prior B7-H3 or topoisomerase I inhibitor therapy, or other active malignancies.", "exclusion_other_malignancies": true, "exclusion_prior_therapies": [ "B7-H3 targeted therapy", "topoisomerase I inhibitors" ], "exclusion_prior_topoisomerase_inhibitor": true, "gender": "Both", "histology": [ "small cell lung cancer" ], "life_expectancy": { "min": 0.23 }, "primary_diagnosis": "Extensive-Stage Small Cell Lung Cancer", "prior_lines_therapy": 0, "recovery_from_prior_therapy_toxicity": false }, "first_posted": "2026-09-03", "has_comparator": true, "has_designations": true, "has_results": false, "has_success_data": false, "industry_collaborators": true, "last_updated": "2026-09-03", "lead_sponsor": false, "line_of_treatment": [ "first-line" ], "main_drug_id": [ "69164a20fa3a26d1c7d63d9f", "67cad00aa9b233378a27a5f3" ], "moa": [ "antagonist" ], "modality_class_ids": [ "GM-04020000", "GM-04000000", "GM-04020100", "GM-04020110", "GM-04010000" ], "multi_arm": false, "nct_id": "NCT07802821", "official_status": "Not yet recruiting", "open_label": true, "pharmacokinetics": false, "phase": "3", "placebo": false, "primary_completion_date": "2029-03-15", "primary_endpoints": [ "Overall survival (OS)" ], "randomized": true, "registry": "ctg", "sponsor_ids": [ "666c8059999fb54d484e4a00" ], "sponsors": [ "Qilu Pharmaceutical" ], "start_date": "2026-10-15", "status": "Active", "status_verified_date": "2026-08", "target_class_ids": [ "GT-11-01", "GT-11", "GT-54", "GT-54-22" ], "target_ids": [ "675b7470df06b1e6c720945f", "675b72853870252f399a5561" ], "therapy_type": "targeted", "title": "QLC5508 + QL2107 vs Tislelizumab + Chemotherapy in Extensive-stage Small Cell Lung Cancer", "trial_id": "NCT07802821" } ]