Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT05055167
Status:
UNKNOWN
Last Update Posted:
2021-09-24
First Post:
2021-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Envafolimab as First-line Treatment of Aged Patients in Advanced 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': 'C000718749', 'term': 'envafolimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '48 months', 'description': 'The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of Almonertinib to the end of study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer Stage IV']}, 'descriptionModule': {'briefSummary': 'Explore the efficacy and safety of Envafolimab in first line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer with high PD-L1 expression, view to providing better treatment options for elderly patients with high PD-L1 expression and improving the survival and prognosis of patients .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent.\n* Age strictly at least 70 years.\n* Cytologically or histologically proven NSCLC(adenocarcinoma, epidermoid carcinoma, large-cell carcinoma) of locally advanced (stage IIIb/IIIc), metastatic, or relapsing (stage IV) according to the American Joint Committee on Cancer Staging Handbook.\n* Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region.\n* No previous systemic chemotherapy for lung cancer.\n* PD-L1≥50% in tissue samples detected by immunohistochemistry.\n* PS 0 or 1.\n* Life expectancy sup 12 weeks.\n* Normal hematologic function.\n\nExclusion Criteria:\n\n* EGFR-sensitive mutations or ALK rearrangements\n* Previous treatment with immune checkpoint inhibitors\n* Presence of symptomatic brain metastases；\n* Chinese patent medicine with anti-lung cancer indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for the local use of pleural effusion control) for systemic treatment；\n* Another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ；\n* Concurrent administration of one or several other antitumor therapies；\n* Concurrent participation in another clinical trial；\n* Active autoimmune disease requiring systemic treatment occurred within 2 years prior to initial；\n* Systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to initial administration；\n* Contraindication to the study drugs；\n* Has not fully recovered from toxicity and/or complications caused by any intervention prior to the commencement of treatment (i.e., grade 1 or baseline, excluding fatigue or hair loss);\n* A history of human immunodeficiency virus (HIV) infection;\n* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the research center);\n* Active HCV infected;\n* Recent vaccination within 30 days before the first administration (cycle 1, day 1);\n* Other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, NYHA class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections).'}, 'identificationModule': {'nctId': 'NCT05055167', 'briefTitle': 'Envafolimab as First-line Treatment of Aged Patients in Advanced NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xiamen University'}, 'officialTitle': 'A Phase II Study of Envafolimab as First-line Treatment of Aged Patients With High PD-L1 Expression Stage in Advanced Non-small-cell Lung Cancer(NSCLC)', 'orgStudyIdInfo': {'id': 'SMA-NSCLC-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Envafolimab', 'description': 'Elderly NSCLC Patients with high PD-L1 expression', 'interventionNames': ['Drug: Envafolimab']}], 'interventions': [{'name': 'Envafolimab', 'type': 'DRUG', 'description': 'single agent, 300mg Q3W IH until disease progressed', 'armGroupLabels': ['Envafolimab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'First affiliated Hospital of Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}