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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00952 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| LUN0088 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
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This phase II trial studies how well radical-dose image guided radiation therapy works in treating patients with non-small cell lung cancer that has spread to other places in the body who are undergoing immunotherapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radical-dose image guided radiation therapy to patients with non-small cell lung cancer may help to improve response to immunotherapy anti-cancer treatment.
PRIMARY OBJECTIVES:
I. Determine if progression-free survival at 24 weeks with this treatment combination is improved compared to historical controls who received immunotherapy without radiation therapy.
SECONDARY OBJECTIVES:
I. Assess acute (0-6 months) and late (> 6 months) grade 3-5 toxicity. II. Assess overall survival. III. Correlate circulating tumor deoxyribonucleic acid (DNA) (ratio of post-radiation therapy [RT] to pre-RT level) with radiographic response.
IV. Correlate immune markers in peripheral blood with radiographic response.
TERTIARY OBJECTIVES:
I. Analyze progression-free survival with immune-related response criteria. II. Measure time to discontinuation of study immunotherapy agent. III. Assess patterns of progression.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while undergoing standard of care immunotherapy.
Arm II: Patients who decline to undergo radiation therapy receive standard of care immunotherapy.
After completion of study treatment, patients are followed up at 30 days and every 6 months thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy plus Image-guided Radiation Therapy | Experimental | Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while continuing their prior treatment with the treating physician's choice of regular medical care immunotherapy. |
|
| Immunotherapy Alone (Regular Medical Care) | Active Comparator | Patients who decline to undergo radiation therapy will continue their prior treatment with the treating physician's choice of regular medical care immunotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image-guided Radiation Therapy | Radiation | Ablative treatment as 50 Gy in 5 or 10 fractions. Non-ablative treatment as 27 Gy in 3 fractions, or 40 Gy in 10 fractions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Defined as percentage of participants without disease progression or death at 24 weeks from date of study entry, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions Overall Response (OR): CR + PR | 24 weeks from study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Circulating Tumor Deoxyribonucleic Acid Levels as Measured Using CAncer Personalized Profiling by Deep Sequencing | Will correlate with radiographic response. Plasma biomarkers (e.g. cell free deoxyribonucleic acid level) will be summarized using medians and interquartile ranges; changes in biomarkers will be assessed using the Wilcoxon signed rank test. Correlation of biomarkers with radiographic response will be evaluated using a Wilcoxon rank sum test on patients with and without the event of interest. If feasible, these analyses will be supplemented by more formal analyses with the Cox model. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Tumor Response (Including Abscopal Responses) | Number of participants who experienced a tumor response, including abscopal responses, following image-guided radiation therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Inclusion Criteria:
Has stage IV non-small cell lung cancer, or initially stage I-III disease with distant metastatic recurrence
Age ≥ 18
Has been receiving anti-PD-1 or anti-PD-L1 immunotherapy for at least four weeks (refer to section 4.2.1)
Has had restaging imaging after initiation of immunotherapy, at least 4 weeks after pre-immunotherapy baseline imaging. CT or PET/CT of at least chest/upper abdomen must be performed within 4 weeks prior to registration. For patients with history of brain metastases, brain MRI or CT is required within 4 weeks of registration; for other patients brain MRI or CT is required within 12 weeks of registration. Diagnostic PET/CT performed as part of radiation simulation can be used as the restaging imaging.
Most recent imaging shows measurable disease as defined by RECIST 1.1
Evaluation by a Stanford medical oncologist must show:
Has at least one extracranial tumor safely treatable with radical-dose radiation therapy and that has not been previously treated with radiation
ECOG performance status 0-2
Has the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gensheimer | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
Although the 'Immunotherapy Alone (Regular Medical Care)' arm was included in the study design, no participants were enrolled or assigned to this arm
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| ID | Title | Description |
|---|---|---|
| FG000 | Immunotherapy Plus Image-guided Radiation Therapy | Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while continuing their prior treatment with the treating physician's choice of regular medical care immunotherapy. Image-guided Radiation Therapy: Ablative treatment as 50 Gy in 5 or 10 fractions. Non-ablative treatment as 27 Gy in 3 fractions, or 40 Gy in 10 fractions. Immunotherapy (physician's choice for standard of care immunotherapy): Continue regular medical care immunotherapy. Other than being an anti-PD-1 or anti-PD-L1 immunotherapy, the agent, dose, and schedule is not specified by protocol. |
| FG001 | Immunotherapy Alone (Regular Medical Care) | Patients who decline to undergo radiation therapy will continue their prior treatment with the treating physician's choice of regular medical care immunotherapy. Immunotherapy (physician's choice for standard of care immunotherapy): Continue regular medical care immunotherapy. Other than being an anti-PD-1 or anti-PD-L1 immunotherapy, the agent, dose, and schedule is not specified by protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only participants were enrolled in Arm 1 (Immunotherapy plus Image-guided Radiation Therapy); therefore, no baseline data are available for Arm 2 (Immunotherapy Alone).
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| ID | Title | Description |
|---|---|---|
| BG000 | Immunotherapy Plus Image-guided Radiation Therapy | Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while continuing their prior treatment with the treating physician's choice of regular medical care immunotherapy. Image-guided Radiation Therapy: Ablative treatment as 50 Gy in 5 or 10 fractions. Non-ablative treatment as 27 Gy in 3 fractions, or 40 Gy in 10 fractions. Immunotherapy (physician's choice for standard of care immunotherapy): Continue regular medical care immunotherapy. Other than being an anti-PD-1 or anti-PD-L1 immunotherapy, the agent, dose, and schedule is not specified by protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Defined as percentage of participants without disease progression or death at 24 weeks from date of study entry, assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): ≥30% decrease in the sum of the longest diameter of target lesions Overall Response (OR): CR + PR | Posted | Count of Participants | Participants | 24 weeks from study entry |
|
4 years
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immunotherapy Plus Image-guided Radiation Therapy | Patients undergo radical-dose image guided radiation therapy daily for up to 10 days (within 2 weeks) while continuing their prior treatment with the treating physician's choice of regular medical care immunotherapy. Image-guided Radiation Therapy: Ablative treatment as 50 Gy in 5 or 10 fractions. Non-ablative treatment as 27 Gy in 3 fractions, or 40 Gy in 10 fractions. Immunotherapy (physician's choice for standard of care immunotherapy): Continue regular medical care immunotherapy. Other than being an anti-PD-1 or anti-PD-L1 immunotherapy, the agent, dose, and schedule is not specified by protocol. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other - Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
Several pre-specified biomarker and imaging outcomes were not analyzed due to lack of funding for laboratory processing or because analyses were deemed not scientifically relevant at the time of final review. No future analyses are planned for these measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Associate Professor, Radiation Oncology - Radiation Therapy | Stanford University | (650) 723-6171 | mgens@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 4, 2021 | Jun 15, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D061089 | Radiotherapy, Image-Guided |
| D007167 | Immunotherapy |
| D001691 | Biological Therapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D056747 | Immunomodulation |
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|
| Immunotherapy (physician's choice for standard of care immunotherapy) | Drug | Continue regular medical care immunotherapy. Other than being an anti-PD-1 or anti-PD-L1 immunotherapy, the agent, dose, and schedule is not specified by protocol. |
|
|
| Baseline (pre-treatment) |
| Change in Immune Marker Levels as Measured From Peripheral Blood Using Flow Cytometry Performed by the Human Immune Monitoring Core at Stanford University | Change in immune marker levels was measured using flow cytometry performed by the Human Immune Monitoring Core at Stanford University. These changes will correlate with radiographic response. | Pre-radiation (up to 14 days before RT) and post-radiation (up to 14 days after completion of RT) |
| Number of Participants With Acute (0-6 Months) and Late (> 6 Months) Grade 3-5 Toxicity | This outcome measured the number of participants who experienced Grade 3-5 acute (0-6 months) and late (>6 months) toxicities, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4, through up to 4 years after study entry. | Up to 4 years after study entry |
| Overall Survival | The electronic medical record was monitored for patient deaths. | Time from study entry to death, assessed up to 4 years after study entry |
| Up to 4 years |
| Progression Free Survival | Evaluated with immune-related Response Criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Pre-radiation (up to 14 days before RT) and post-radiation (up to 14 days after completion of RT) |
| Time to Discontinuation of Study Immunotherapy Agent | Time to discontinuation of study immunotherapy agent was measured. | Up to 4 years |
| BG001 | Immunotherapy Alone (Regular Medical Care) | Patients who decline to undergo radiation therapy will continue their prior treatment with the treating physician's choice of regular medical care immunotherapy. Immunotherapy (physician's choice for standard of care immunotherapy): Continue regular medical care immunotherapy. Other than being an anti-PD-1 or anti-PD-L1 immunotherapy, the agent, dose, and schedule is not specified by protocol. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Change in Circulating Tumor Deoxyribonucleic Acid Levels as Measured Using CAncer Personalized Profiling by Deep Sequencing | Will correlate with radiographic response. Plasma biomarkers (e.g. cell free deoxyribonucleic acid level) will be summarized using medians and interquartile ranges; changes in biomarkers will be assessed using the Wilcoxon signed rank test. Correlation of biomarkers with radiographic response will be evaluated using a Wilcoxon rank sum test on patients with and without the event of interest. If feasible, these analyses will be supplemented by more formal analyses with the Cox model. | Blood samples were collected for this outcome measure, however, no laboratory analysis was conducted due to lack of funding. No future analyses are planned. | Posted | Baseline (pre-treatment) |
|
|
| Secondary | Change in Immune Marker Levels as Measured From Peripheral Blood Using Flow Cytometry Performed by the Human Immune Monitoring Core at Stanford University | Change in immune marker levels was measured using flow cytometry performed by the Human Immune Monitoring Core at Stanford University. These changes will correlate with radiographic response. | Peripheral blood samples were collected at the pre-specified time points, but immune marker levels were not analyzed due to lack of funding for laboratory processing. No future analyses are planned. | Posted | Pre-radiation (up to 14 days before RT) and post-radiation (up to 14 days after completion of RT) |
|
|
| Secondary | Number of Participants With Acute (0-6 Months) and Late (> 6 Months) Grade 3-5 Toxicity | This outcome measured the number of participants who experienced Grade 3-5 acute (0-6 months) and late (>6 months) toxicities, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4, through up to 4 years after study entry. | Posted | Count of Participants | Participants | Up to 4 years after study entry |
|
|
|
| Secondary | Overall Survival | The electronic medical record was monitored for patient deaths. | Posted | Median | 95% Confidence Interval | months | Time from study entry to death, assessed up to 4 years after study entry |
|
|
|
| Other Pre-specified | Number of Participants With Tumor Response (Including Abscopal Responses) | Number of participants who experienced a tumor response, including abscopal responses, following image-guided radiation therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Count of Participants | Participants | Up to 4 years |
|
|
|
| Other Pre-specified | Progression Free Survival | Evaluated with immune-related Response Criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Imaging data were collected for assessment of progression-free survival using immune-related response criteria (iRRC); however, these data were not analyzed because the outcome was deemed not scientifically relevant at the time of final analysis. No future analyses are planned. | Posted | Pre-radiation (up to 14 days before RT) and post-radiation (up to 14 days after completion of RT) |
|
|
| Other Pre-specified | Time to Discontinuation of Study Immunotherapy Agent | Time to discontinuation of study immunotherapy agent was measured. | Posted | Median | Inter-Quartile Range | Months | Up to 4 years |
|
|
|
| 1 |
| 44 |
| 6 |
| 44 |
| 32 |
| 44 |
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Other - Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
|
| Papulopustular rash | Infections and infestations | Systematic Assessment |
|
| Toothache | General disorders | 1 | Systematic Assessment |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |