Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT05940532
Status:
RECRUITING
Last Update Posted:
2023-07-11
First Post:
2023-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723018', 'term': 'sugemalimab'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 41}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-07', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-07-07', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'From the initiation of the first dose to 3 years', 'description': 'Objective response rate'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'From the initiation of the first dose to 3 years', 'description': 'Progression-free survival'}, {'measure': 'OS', 'timeFrame': 'From the initiation of the first dose to 3 years', 'description': 'Overall survival'}, {'measure': 'iORR', 'timeFrame': 'From the initiation of the first dose to 3 years', 'description': 'Objective response rate after induction therapy'}, {'measure': 'AEs', 'timeFrame': 'From the initiation of the first dose to 90 days after the last dose', 'description': 'Adverse events'}, {'measure': 'Measurement of Quality of Life with EORTC QLQ-C30 questionnaire', 'timeFrame': 'From the initiation of the first dose to 3 years', 'description': 'EORTC QLQ-C30 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome'}, {'measure': 'Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire', 'timeFrame': 'From the initiation of the first dose to 3 years', 'description': 'EORTC QLQ-LC13 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome'}, {'measure': 'Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire', 'timeFrame': 'From the initiation of the first dose to 3 years', 'description': 'The EQ-5D-5L VAS records the respondent\'s self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine"'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immunotherapy', 'chemotherapy', 'radiotherapy', 'surgery', 'non-small cell lung cancer'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.18 to 75 years old, both male and female;\n\n2.ECOG score: 0-1;\n\n3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;\n\n4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;\n\n5.Measurable lesions available;\n\n6.Major organ function is basically normal;\n\n7.Estimated survival time is at least 6 months;\n\n8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed mixed SCLC and NSCLC;\n2. Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);\n3. Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;\n4. Previous thoracic radiotherapy;\n5. Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;\n6. Systemic immunostimulant therapy before the first dose;\n7. Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;\n8. Subjects with autoimmune diseases;\n9. Other malignant tumors other than non-small cell lung cancer within 5 years before screening;\n10. Known or suspected interstitial pneumonia;\n11. Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;\n12. Severe cardiovascular and cerebrovascular diseases;\n13. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;\n14. Arteriovenous thrombotic events within 3 months before the first dose;\n15. Positive HIV test;\n16. Active hepatitis B or C;\n17. Evidence of active tuberculosis infection within 1 year before the first dose;\n18. Serious infection within 4 weeks before the first dose;\n19. History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;\n20. Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;\n21. Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;\n22. History of severe allergic reactions to other monoclonal antibodies/fusion proteins;\n23. Allergic to any component of the randomized treatment regimen;\n24. Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;\n25. Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;\n26. Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.'}, 'identificationModule': {'nctId': 'NCT05940532', 'briefTitle': 'A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Cancer Hospital'}, 'officialTitle': 'A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'HTOSG Lung 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional arm', 'description': 'Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.', 'interventionNames': ['Drug: Sugemalimab and Chemotherapy']}], 'interventions': [{'name': 'Sugemalimab and Chemotherapy', 'type': 'DRUG', 'description': 'Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles.\n\nSugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.', 'armGroupLabels': ['Interventional arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huai Liu, MD', 'role': 'CONTACT', 'email': 'liuhuai@hnca.org.cn', 'phone': '+8619918909231'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Huai Liu, MD', 'role': 'CONTACT', 'email': 'liuhuai@hnca.org.cn', 'phone': '+8619918909231'}], 'overallOfficials': [{'name': 'Hui Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the Department of Radiation Oncology'}, {'name': 'Huai Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the Department of Radiation Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunan Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}