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Chemotherapy Combined With Immunotherapy vs Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

Primary Purpose

Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Carboplatin
Computed Tomography
Magnetic Resonance Imaging
Nab-paclitaxel
Paclitaxel
Pembrolizumab
Pemetrexed
Positron Emission Tomography
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Lung Non-Small Cell Carcinoma

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: STEP 1 REGISTRATION Patient must be ≥ 70 years of age Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49% Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible Absolute neutrophil count (ANC) ≥ 1,500/mcL (obtained within 14 days prior to Step 1 registration) Platelets ≥ 75,000/mcL (obtained within 14 days prior to Step 1 registration) Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration) Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration) Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration) Creatinine clearance (CrCL) ≥ 30 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration) Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Patient must be English or Spanish speaking to be eligible for the QOL component of the study NOTE: Sites cannot translate the associated QOL forms Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible STEP 2 RANDOMIZATION Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Arm A (pembrolizumab)

    Arm B (pembrolizumab, chemotherapy)

    Arm Description

    INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI at baseline and CT and/or PET on the trial at baseline and throughout the trial.

    See Detailed Description

    Outcomes

    Primary Outcome Measures

    Overall survival
    Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios. Comparison of OS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 0.025. Other comparisons of groups will be made using the log rank test and Cox modeling.

    Secondary Outcome Measures

    Progression free survival (PFS)
    Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios.
    Six month PFS
    Defined as the proportion of patients who remained alive and progression-free at 6 months. Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios.
    Best objective response
    Will be evaluated via RECIST 1.1 criteria. Best objective response rate is defined as the proportion of patients achieved complete response (CR) or partial response (PR) as best response from the start of the treatment until disease progression/recurrence or start of non-protocol therapy. Patients who do not start treatment and patients who do not have any follow-up disease evaluation and do not meet RECIST criteria for clinical progression are coded as not evaluable. Patients who are not evaluable are included in the calculation of response rates (as non-responders).
    Incidence of adverse events
    Toxicity will be determined using the Common Terminology Criteria for Adverse Events (CTCAE). Toxicity will be assessed by summaries by CTCAE grade.
    Evaluation of quality of life (QOL) measures
    Quality of life evaluations will be conducted using questionnaires at time of disease evaluation per Functional Assessment of Cancer Therapy (FACT)-Lung version 4. QOL assessment will be gathered and the changes in QOL between the two treatment arms will be compared using Wilcoxon rank sum test.

    Full Information

    First Posted
    October 21, 2023
    Last Updated
    October 21, 2023
    Sponsor
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06096844
    Brief Title
    Chemotherapy Combined With Immunotherapy vs Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
    Official Title
    A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 8, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2026 (Anticipated)
    Study Completion Date
    June 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.
    Detailed Description
    PRIMARY OBJECTIVE: I. To evaluate whether there is an improvement in overall survival (OS) with chemotherapy combined with pembrolizumab compared to single agent pembrolizumab in this vulnerable older adult patient population. SECONDARY OBJECTIVES: I. To evaluate any difference in progression free survival (PFS) with chemotherapy combined with pembrolizumab as compared to single agent pembrolizumab. II. To evaluate the difference in PFS rate at 3 months and at 6 months with chemotherapy combined with pembrolizumab as compared to single agent pembrolizumab. III. To evaluate the difference in best objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria to assess whether chemotherapy combined with pembrolizumab results in improved response rates compared to treatment with single agent pembrolizumab. IV. To evaluate toxicity in those treated with chemotherapy combined with pembrolizumab compared to those treated with single agent pembrolizumab. V. To evaluate patient reported quality of life (QOL) evaluations between treatment arms. EXPLORATORY OBJECTIVES: I. To compare safety and tolerability between treatment arms including but not limited to number of additional lab draws, scan appointments, infusion visits, falls, emergency department visits, and hospitalization related to treatment toxicity. II. To explore factors within the pre-treatment geriatric assessment (GA) as predictors of toxicity and outcomes. To describe changes between the intended chemotherapy treatment planned versus treatment given and referrals placed by treating provider based on GA results. III. To evaluate the assessment of a novel, composite fPFS score using disease progression/functional impairment assessment as a potential correlate to OS in this vulnerable population. IV. To evaluate the correlation of 6-months PFS with OS as a potential surrogate of OS benefit. V. To evaluate the correlation of 6-months PFS with OS as a potential surrogate of OS benefit. VI. To assess elective dose intensity of chemotherapy of patients who receive doublet chemotherapy versus single agent chemotherapy. EXPLORATORY CORRELATIVE OBJECTIVE: I. To relate gut microbe abundances to treatment outcomes, toxicity, and geriatric assessments. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: INDUCTION: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity. ARM B: INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Patients also receive investigator's choice of a chemotherapy regimen: 1) Pemetrexed IV over 10 minutes + carboplatin IV over 30-60 minutes on day 1 of each cycle; 2) Nab-paclitaxel IV over 30 on days 1, 8, and 15 of each cycle + carboplatin IV over 30-60 minutes on day 1 of each cycle; 3) Paclitaxel IV over 1 hour on day 1, 8, and 15 of each cycle or over 3 hours on day 1 of each cycle + carboplatin IV over 30-60 minutes on day 1 of each cycle; 4) Nab-paclitaxel IV over 30 minutes on days 1, 8 and 15 of each cycle; 5) Paclitaxel IV over 3 hours on day 1 of each cycle or over 1 hour on days 1, 8, and 15 of each cycle; or 6) Pemetrexed IV over 10 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity. All patients undergo magnetic resonance imaging (MRI) at baseline and computed tomography (CT) and/or positron emission tomography (PET) on the trial at baseline and throughout the trial. After completion of study treatment, patients are followed up every 3 months if < 2 years from randomization and every 6 months if 2-5 years from Step 1 registration.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    304 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A (pembrolizumab)
    Arm Type
    Active Comparator
    Arm Description
    INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI at baseline and CT and/or PET on the trial at baseline and throughout the trial.
    Arm Title
    Arm B (pembrolizumab, chemotherapy)
    Arm Type
    Experimental
    Arm Description
    See Detailed Description
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Other Intervention Name(s)
    Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
    Intervention Description
    Given IV
    Intervention Type
    Procedure
    Intervention Name(s)
    Computed Tomography
    Other Intervention Name(s)
    CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
    Intervention Description
    Undergo CT scan
    Intervention Type
    Procedure
    Intervention Name(s)
    Magnetic Resonance Imaging
    Other Intervention Name(s)
    Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
    Intervention Description
    Undergo MRI
    Intervention Type
    Drug
    Intervention Name(s)
    Nab-paclitaxel
    Other Intervention Name(s)
    ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Paclitaxel Nanoparticle Albumin-bound, Paclitaxel Protein-Bound, Protein-bound Paclitaxel
    Intervention Description
    Given IV
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Other Intervention Name(s)
    Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
    Intervention Description
    Given IV
    Intervention Type
    Biological
    Intervention Name(s)
    Pembrolizumab
    Other Intervention Name(s)
    BCD-201, Keytruda, Lambrolizumab, MK-3475, Pembrolizumab Biosimilar BCD-201, SCH 900475
    Intervention Description
    Given IV
    Intervention Type
    Drug
    Intervention Name(s)
    Pemetrexed
    Other Intervention Name(s)
    MTA, Multitargeted Antifolate, Pemfexy
    Intervention Description
    Given IV
    Intervention Type
    Procedure
    Intervention Name(s)
    Positron Emission Tomography
    Other Intervention Name(s)
    Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
    Intervention Description
    Undergo PET
    Intervention Type
    Other
    Intervention Name(s)
    Quality-of-Life Assessment
    Other Intervention Name(s)
    Quality of Life Assessment
    Intervention Description
    Ancillary studies
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire Administration
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    Overall survival
    Description
    Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios. Comparison of OS will use a logrank test stratified on the randomization stratification factors with a one-sided type I error rate of 0.025. Other comparisons of groups will be made using the log rank test and Cox modeling.
    Time Frame
    From randomization to death from any cause, and patients who are alive at the time of final analysis will be censored at the last date of contact, assessed up to 5 years
    Secondary Outcome Measure Information:
    Title
    Progression free survival (PFS)
    Description
    Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios.
    Time Frame
    From randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death from any cause, whichever occurs first, assessed up to 5 years
    Title
    Six month PFS
    Description
    Defined as the proportion of patients who remained alive and progression-free at 6 months. Will be estimated using the Kaplan-Meier method, and Cox proportional hazards models will be used to estimate hazard ratios.
    Time Frame
    From randomization to documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first, assessed at 6 months
    Title
    Best objective response
    Description
    Will be evaluated via RECIST 1.1 criteria. Best objective response rate is defined as the proportion of patients achieved complete response (CR) or partial response (PR) as best response from the start of the treatment until disease progression/recurrence or start of non-protocol therapy. Patients who do not start treatment and patients who do not have any follow-up disease evaluation and do not meet RECIST criteria for clinical progression are coded as not evaluable. Patients who are not evaluable are included in the calculation of response rates (as non-responders).
    Time Frame
    Up to 5 years
    Title
    Incidence of adverse events
    Description
    Toxicity will be determined using the Common Terminology Criteria for Adverse Events (CTCAE). Toxicity will be assessed by summaries by CTCAE grade.
    Time Frame
    Up to 2 years
    Title
    Evaluation of quality of life (QOL) measures
    Description
    Quality of life evaluations will be conducted using questionnaires at time of disease evaluation per Functional Assessment of Cancer Therapy (FACT)-Lung version 4. QOL assessment will be gathered and the changes in QOL between the two treatment arms will be compared using Wilcoxon rank sum test.
    Time Frame
    Baseline up to 6 months
    Other Pre-specified Outcome Measures:
    Title
    Gut microbe abundances
    Description
    Will relate gut microbe abundances to treatment outcomes, toxicity, and geriatric assessments.
    Time Frame
    Baseline and after 4 cycles of initial treatment (Cycles = 21 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: STEP 1 REGISTRATION Patient must be ≥ 70 years of age Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49% Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible Absolute neutrophil count (ANC) ≥ 1,500/mcL (obtained within 14 days prior to Step 1 registration) Platelets ≥ 75,000/mcL (obtained within 14 days prior to Step 1 registration) Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration) Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration) Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration) Creatinine clearance (CrCL) ≥ 30 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration) Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Patient must be English or Spanish speaking to be eligible for the QOL component of the study NOTE: Sites cannot translate the associated QOL forms Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible STEP 2 RANDOMIZATION Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Megan A Baumgart
    Organizational Affiliation
    ECOG-ACRIN Cancer Research Group
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    "NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."
    IPD Sharing URL
    https://grants.nih.gov/policy/sharing.htm

    Learn more about this trial

    Chemotherapy Combined With Immunotherapy vs Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

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