Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 10:51 PM
Study NCT ID:
NCT06947694
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000082082', 'term': 'Immune Checkpoint Inhibitors'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000074322', 'term': 'Antineoplastic Agents, Immunological'}, {'id': 'D000970', 'term': 'Antineoplastic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 427}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-04-20', 'studyFirstSubmitQcDate': '2025-04-20', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The remission rate of abscopal lesions', 'timeFrame': 'From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years', 'description': 'The remission rate of abscopal lesions. Immunotherapy is administered within less than 1 week after the start of radiotherapy. The time point for determining the abscopal effect is set as ≤ 4 cycles of immunotherapy. The assessment is carried out in accordance with the RECIST 1.1 (Appendix 1) and iPERCIST criteria.'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years'}, {'measure': 'OS', 'timeFrame': 'up to 5 years'}, {'measure': 'ORR', 'timeFrame': 'From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years'}, {'measure': 'DOR', 'timeFrame': 'From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years'}, {'measure': 'irAE', 'timeFrame': 'From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years', 'description': 'Adverse reactions related to immunotherapy'}, {'measure': 'QoF', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC Stage IV Without EGFR/ALK Mutation']}, 'descriptionModule': {'briefSummary': 'It is planned to carry out a multicenter umbrella study to find the optimal organ combination and the best radioimmunotherapy combination pattern, so as to improve the survival of NSCLC patients with multiple metastases. At the same time, by using multimodal omics data, machine learning will be employed to construct a prediction model for the abscopal effect, and explore the immunoregulation of organ-specific radiotherapy and biomarkers of the abscopal effect. The main objective is to find the optimal organ combination and the best radioimmunotherapy combination pattern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must meet all of the following inclusion criteria to be enrolled in this study:\n\n 1. Non-small cell lung cancer diagnosed initially through pathological histology.\n 2. There are 3-6 metastatic lesions.\n 3. No brain metastasis or the lesions are stable.\n 4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET genes. Note: The above English terms are all gene names).\n 5. ECOG (Eastern Cooperative Oncology Group) score: 0-1 point, with an expected, survival period of more than 3 months.\n 6. Aged between 18 and 75 years old.\n 7. Evaluated by PET-CT (including FDG and FMISO, not mandatory).\n 8. No contraindications for immunotherapy and radiotherapy.\n 9. The informed consent form has been signed.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria are not eligible for enrollment in this study:\n\n 1. Those with severe dysfunction of vital organs (heart, liver, kidney).\n 2. Those accompanied by other malignant tumors.\n 3. Those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months.\n 4. Those with a history of mental illness.\n 5. And other situations in which the researchers deem it inappropriate for the subjects to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06947694', 'briefTitle': 'A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'A Prospective, Multicenter, Umbrella Design Clinical Study on the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases', 'orgStudyIdInfo': {'id': 'XQonc-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Drug: chemotherapy + PD-1 inhibitors']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Drug: chemotherapy + PD-1 inhibitors']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'interventionNames': ['Drug: chemotherapy + PD-1 inhibitors']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'interventionNames': ['Drug: chemotherapy + PD-1 inhibitors']}, {'type': 'EXPERIMENTAL', 'label': 'Group E', 'interventionNames': ['Drug: chemotherapy + PD-1 inhibitors']}, {'type': 'EXPERIMENTAL', 'label': 'Group F', 'interventionNames': ['Drug: chemotherapy + PD-1 inhibitors']}, {'type': 'EXPERIMENTAL', 'label': 'Group G', 'interventionNames': ['Drug: chemotherapy + PD-1 inhibitors']}], 'interventions': [{'name': 'chemotherapy + PD-1 inhibitors', 'type': 'DRUG', 'otherNames': ['Radiotherapy'], 'description': 'The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8Gy \\* 3-10 fractions) for pulmonary lesions, lymph node lesions and visceral lesions in combination with the PD-1 inhibitors . During the follow-up, the PD-1 inhibitors will be maintained until the disease progresses or the toxicity is intolerable. The maximum duration of immunotherapy shall not exceed 2 years.', 'armGroupLabels': ['Group A']}, {'name': 'chemotherapy + PD-1 inhibitors', 'type': 'DRUG', 'otherNames': ['Radiotherapy'], 'description': 'The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for pulmonary lesions, lymph node lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.', 'armGroupLabels': ['Group B']}, {'name': 'chemotherapy + PD-1 inhibitors', 'type': 'DRUG', 'otherNames': ['Radiotherapy'], 'description': 'The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8Gy × 3-10 fractions) for pulmonary lesions, lymph node lesions and bone metastatic lesions in combination with the PD-1 inhibitors . During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.', 'armGroupLabels': ['Group C']}, {'name': 'chemotherapy + PD-1 inhibitors', 'type': 'DRUG', 'otherNames': ['Radiotherapy'], 'description': 'The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be maintained until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.', 'armGroupLabels': ['Group D']}, {'name': 'chemotherapy + PD-1 inhibitors', 'type': 'DRUG', 'otherNames': ['Radiotherapy'], 'description': 'The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for pulmonary lesions, visceral lesions and bone metastatic lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.', 'armGroupLabels': ['Group E']}, {'name': 'chemotherapy + PD-1 inhibitors', 'type': 'DRUG', 'otherNames': ['Radiotherapy'], 'description': 'The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.', 'armGroupLabels': ['Group F']}, {'name': 'chemotherapy + PD-1 inhibitors', 'type': 'DRUG', 'otherNames': ['Radiotherapy'], 'description': 'The patient receives 4 cycles of treatment with "chemotherapy + PD-1 inhibitors". If there is no disease progression, the patient will receive radiotherapy (radiation dose: 5-8 Gy × 3-10 fractions) for lymph node lesions, visceral lesions and other lesions in combination with the PD-1 inhibitors. During the follow-up, the PD-1 inhibitors will be continued until the disease progresses or the toxicity becomes intolerable. The maximum duration of immunotherapy shall not exceed 2 years.', 'armGroupLabels': ['Group G']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400037', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianguo Sun, Phd', 'role': 'CONTACT', 'email': 'sunjg09@aliyun.com', 'phone': '023-68774490'}], 'facility': 'the second affiliated hospital of Army medical university', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Jianguo Sun, MD', 'role': 'CONTACT', 'email': 'sunjg09@aliyun.com', 'phone': '023-68774490'}], 'overallOfficials': [{'name': 'Jianguo Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof', 'investigatorFullName': 'Jianguo Sun', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}}