Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-09 @ 4:37 AM
Study NCT ID:
NCT03833934
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eizzo@alcmi.org', 'phone': '941-713-1225', 'title': 'Ericka Izzo, Clinical Project Manager', 'organization': 'Addario Lung Cancer Medical Institute (ALCMI)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data not applicable for this study', 'description': 'Adverse event data not applicable for this study', 'eventGroups': [{'id': 'EG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of ALK Fusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '32 months', 'description': 'To determine the prevalence of the ALK gene fusion in the cohort of patients with ALK-positive NSCLC with progression', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'ALK Fusion Allelic Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '32 months', 'description': "To determine the relative percentage of the ALK fusion within the cohort's gene pool", 'unitOfMeasure': 'percentage of the ALK fusion', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with detected ALK fusion'}, {'type': 'PRIMARY', 'title': 'Overall Prevalence of ALK Resistance Mechanism Among Patients With the ALK Fusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '32 months', 'description': 'To determine the overall prevalence of ALK resistance mechanism in patients with detectable ALK fusion in plasma as determined per plasma NGS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with detected ALK fusion'}, {'type': 'PRIMARY', 'title': 'Type of Resistance Mechanism: One or More Secondary ALK Kinase Domain Resistance Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '32 months', 'description': 'To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with detected ALK fusion'}, {'type': 'PRIMARY', 'title': 'Type of ALK Resistance Mechanism: Both ALK Resistance Mutations and Bypass Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '32 months', 'description': 'To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with detected ALK fusion'}, {'type': 'PRIMARY', 'title': 'Prevalance of ALK Restance Mechanism: Bypass Track Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '32 months', 'description': 'To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with detected ALK fusion'}, {'type': 'SECONDARY', 'title': 'Changed Treatment for NSCLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '32 months', 'description': 'Initiated a new ALK tyrosine kinase inhibitor for treatment of NSCLC following enrollment in the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with at least 3 months of follow-up time'}, {'type': 'SECONDARY', 'title': 'Treatment Outcome: >50% Reduction of ALK Fusion Allelle Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '32 months', 'description': 'New ALK TKI treatment resulted in \\>50% reduction of ALK fusion allelle frequency', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had additional optional blood draw following initiation of new ALK TKI therapy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were referred by means of their treating physician or social media to a study website (https://alcmi.net/research/spacewalk-study/) and completed a contact form indicating their interest in participating in the study and answered a prescreening questionnaire. If the patients indicated they have ALK-positive NSCLC and are progressing on an ALK TKI, they were contacted by the study staff who then released access to an online consent form to the patient.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ALK-positive NSCLC With Progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '81'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Region of Enrollment, Study conducted in United States', 'unitOfMeasure': 'participants'}, {'title': 'Subjects diagnosed with Advanced ALK positive NSCLC with progression', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-15', 'size': 569646, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-07T11:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood specimens will be tested for genetic mutations in ALK and other genes that may be important for lung cancer. The participant and their doctor will receive a copy of the test results. The test results will describe the gene alterations that are detected in the blood sample. The assay covers a region of the ALK gene and other lung cancer genes where resistance alterations can occur.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2019-01-28', 'resultsFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-16', 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of ALK Fusion', 'timeFrame': '32 months', 'description': 'To determine the prevalence of the ALK gene fusion in the cohort of patients with ALK-positive NSCLC with progression'}, {'measure': 'ALK Fusion Allelic Frequency', 'timeFrame': '32 months', 'description': "To determine the relative percentage of the ALK fusion within the cohort's gene pool"}, {'measure': 'Overall Prevalence of ALK Resistance Mechanism Among Patients With the ALK Fusion', 'timeFrame': '32 months', 'description': 'To determine the overall prevalence of ALK resistance mechanism in patients with detectable ALK fusion in plasma as determined per plasma NGS'}, {'measure': 'Type of Resistance Mechanism: One or More Secondary ALK Kinase Domain Resistance Mutations', 'timeFrame': '32 months', 'description': 'To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS'}, {'measure': 'Type of ALK Resistance Mechanism: Both ALK Resistance Mutations and Bypass Resistance', 'timeFrame': '32 months', 'description': 'To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS'}, {'measure': 'Prevalance of ALK Restance Mechanism: Bypass Track Resistance', 'timeFrame': '32 months', 'description': 'To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS'}], 'secondaryOutcomes': [{'measure': 'Changed Treatment for NSCLC', 'timeFrame': '32 months', 'description': 'Initiated a new ALK tyrosine kinase inhibitor for treatment of NSCLC following enrollment in the study'}, {'measure': 'Treatment Outcome: >50% Reduction of ALK Fusion Allelle Frequency', 'timeFrame': '32 months', 'description': 'New ALK TKI treatment resulted in \\>50% reduction of ALK fusion allelle frequency'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALK positive'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '34590008', 'type': 'RESULT', 'citation': 'Lawrence MN, Tamen RM, Martinez P, Sable-Hunt A, Addario T, Barbour P, Shaffer T, Hosseini SA, Bertucci C, Lim LP, Hong F, Michael K, Simon GR, Riess JW, Awad MM, Oxnard GR. SPACEWALK: A Remote Participation Study of ALK Resistance Leveraging Plasma Cell-Free DNA Genotyping. JTO Clin Res Rep. 2021 Feb 3;2(4):100151. doi: 10.1016/j.jtocrr.2021.100151. eCollection 2021 Apr.'}]}, 'descriptionModule': {'briefSummary': "ALK-positive lung cancer is a subtype of lung cancer which carries a change in a gene called ALK (anaplastic lymphoma kinase). There are now many drugs for patients with ALK-positive lung cancer that slow cancer growth. However, after some time, just as bacteria evolve resistance to antibiotics, ALK-positive lung cancers evolve ways to avoid the therapies by developing new mutations so the drugs lost their effectiveness. These new mutations can potentially be treated with a different drug. For these new therapies, the range of mutations that can develop at resistance is not well understood.\n\nIt is now possible to detect the presence of mutations or changes in the genetic structure in lung cancer by analyzing a patient's blood for bits of material shed by tumor. This approach is often called a liquid biopsy. Recently, researchers have shown that looking at tumor molecules through liquid biopsies can provide doctors with some of the same information that tissue biopsies provide. For example, liquid biopsies can be used to detect mutations that cause drug resistance. Obtaining liquid biopsies on patients with ALK-positive lung cancers at resistance to therapy may help better understand the different mutations that develop and guide therapy decisions.\n\nIn this research study, a blood specimen will be collected and submitted for liquid biopsy analysis at a commercial diagnostic company. This company specializes in analyzing tumor material found in blood. Specifically, it will look for genetic changes in the ALK gene that could help understand why a cancer has developed drug resistance.\n\nThis research study is for lung cancer patients with ALK-positive lung cancer who had been on a newer ALK targeted treatment (such as ceritinib, alectinib, brigatinib, or lorlatinib) to determine whether they have developed ALK resistance mutations. The investigators will collect a blood sample to examine these mutations. Participants will not have to have a tissue biopsy to participate in this study. Participants do not have to visit Dana-Farber Cancer Institute (DFCI) to participate. All study procedures will be performed remotely.", 'detailedDescription': "SPACEWALK is an innovative remote consent and participation study using next-generation sequencing (NGS) of plasma cell-free DNA (cfDNA) to characterize resistance mechanisms arising in ALK-positive non-small cell lung cancer (NSCLC) after progression while on a next generation ALK tyrosine kinase inhibitor (TKI). Additionally, the study will capture the potential of genomic-driven resistance therapy approach for effecting outcomes in patients with advanced ALK-positive NSCLC and TKI resistance. Finally, the study will assess the role of repeat plasma NGS in evaluating drug response.\n\nThe study will accrue patients with advanced ALK-positive NSCLC on systemic progression (outside the brain) while on treatment with a next-generation ALK TKI. Any patient interested in the study will find information about the study on the study website. The patient will consent remotely through the study website and documentation of advanced ALK-positive NSCLC and systemic progression while on a next-generation ALK TKI. The study team will reach out to the patient to confirm eligibility and send a blood collection kit. In the study kit the study participants will find all the necessary materials for local blood draws, and collected specimens will be sent directly to the central study laboratory (Resolution Bioscience) for plasma NGS.\n\nPlasma NGS of cfDNA will involve sequencing of 19 genes, including ALK, permitting remote tumor genotyping. Plasma NGS analysis and results will be done following standard procedures of the Resolution Bioscience CLIA-certified laboratory. Results will be sent to study participants, their physicians and study team within 1-2 weeks. Plasma NGS reports will not include any specific treatment recommendations but will describe the presence of an ALK rearrangement, ALK resistance mutation, or other relevant mutations.\n\nStudy participants are followed remotely. The study coordinator will contact the participants weekly for 4 weeks after enrolled into the study to learn of any new treatment initiation and to release an additional plasma collection kit 2-4 weeks after starting treatment. Study participants will then be remotely contacted every 3 months to follow clinical outcomes on therapy for up to 2 years. If the cancer progresses on the participant's new treatment, the patient will have the option to provide a third blood specimen. Medical records and local imaging will be collected and studied.\n\nThe primary objective of the study is to characterize ALK TKI resistance to next-generation ALK TKIs in patients with advanced ALK-positive NSCLC. Secondarily, the investigators will assess the potential of plasma NGS to impact outcome on treatment by studying time to treatment discontinuation. Serial plasma NGS will also be assessed as a response biomarker. A total of 300 patients are planned to be enrolled, with the expectation that approximately 200 will have tumor-related mutations detected in plasma NGS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This research study is for lung cancer patients with ALK-positive lung cancer who had been on a newer ALK targeted treatment (such as ceritinib, alectinib, brigatinib, or larlatinib).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women older than 18 years at the time of consent.\n* Demonstration of having advanced ALK positive NSCLC.\n* Systemic progression (not CNS only progression) within the past 30 days while receiving a next generation ALK TKI.\n* Patient must not have started a new line of therapy before signing the informed consent form.\n* Willingness to provide a blood specimen prior to the initiation of a new line of treatment.\n* Willing to provide clinical and medical information to the study team as required.\n* Ability to read, write and communicate in English.\n* Ability to sign a web-based informed consent form.\n\nExclusion Criteria:\n\n* Participants who are unable to provide informed consent.\n* Participants who are 18 years of age or younger.\n* Participants who are unable to comply with the study procedures.\n* Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.\n* Participants who have previously enrolled to the study'}, 'identificationModule': {'nctId': 'NCT03833934', 'acronym': 'SPACEWALK', 'briefTitle': 'Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Addario Lung Cancer Medical Institute'}, 'officialTitle': 'ALCMI-011: Study of Plasma Next Generation Sequencing for Assessment, Characterization, Evaluation of Patients With ALK Resistance (SPACEWALK)', 'orgStudyIdInfo': {'id': 'ALCMI-011'}, 'secondaryIdInfos': [{'id': '5R21CA234816', 'link': 'https://reporter.nih.gov/quickSearch/5R21CA234816', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALK-positive NSCLC with progression', 'description': 'Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Geoffrey R Oxnard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addario Lung Cancer Medical Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}