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Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, ALCHEMIST Chemo-IO Study

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ClinicalTrials.gov Identifier: NCT04267848
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE February 12, 2020
First Posted Date  ICMJE February 13, 2020
Last Update Posted Date July 12, 2021
Actual Study Start Date  ICMJE June 3, 2020
Estimated Primary Completion Date December 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
  • Disease free survival (DFS) [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
    Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. DFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.
  • Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
    Will be estimated using the Kaplan-Meier method, where the stratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2021)
  • DFS between combination pembrolizumab with standard of care versus (vs.) sequential pembrolizumab [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
  • OS between combination pembrolizumab with standard of care vs. sequential pembrolizumab [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
  • Incidence of adverse events [ Time Frame: Up to 10 years ]
    The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5. The frequency and percentage of grade 3+ adverse events will be compared between the 2 experimental treatment arms and the control as well as between the two experimental arms. We will also compare the rate of drug discontinuation due to adverse events between the experimental treatment arms and control, and between the two experimental arms. Comparisons between arms will be made by using the Chi-square test. Analysis of the overall adverse event rates, as well as specific events of interest will involve Chi-square tests or Fisher's exact tests.
  • DFS between each experimental pembrolizumab plus standard of care arms vs. standard of care [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
    Assessed by PD-L1 expression status (tumor proportion score >= 50% vs. tumor proportion score < 50%). Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.
  • OS between each experimental pembrolizumab plus standard of care arms vs. standard of care [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
    Assessed by PD-L1 expression status. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
  • DFS between combination pembrolizumab with standard of care vs. sequential pembrolizumab [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
  • OS between combination pembrolizumab with standard of care vs. sequential pembrolizumab [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
  • Incidence of adverse events [ Time Frame: Up to 10 years ]
    The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5. The frequency and percentage of grade 3+ adverse events will be compared between the 2 experimental treatment arms and the control as well as between the two experimental arms. We will also compare the rate of drug discontinuation due to adverse events between the experimental treatment arms and control, and between the two experimental arms. Comparisons between arms will be made by using the Chi-square test. Analysis of the overall adverse event rates, as well as specific events of interest will involve Chi-square tests or Fisher's exact tests.
  • DFS between each experimental pembrolizumab plus standard of care arms vs. standard of care by PD-L1 expression status [ Time Frame: From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion ]
    Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.
  • OS between each experimental pembrolizumab plus standard of care arms vs. standard of care by PD-L1 expression status [ Time Frame: From randomization to death from any cause, assessed up to 8 years after accrual completion ]
    Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, ALCHEMIST Chemo-IO Study
Official Title  ICMJE Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)
Brief Summary This phase III ALCHEMIST trial compares the addition of pembrolizumab to usual chemotherapy versus usual chemotherapy for the treatment of stage IB, II, or IIIA non-small cell lung cancer that has been removed by surgery. 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. Drugs used in chemotherapy, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, 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. The purpose of this trial is to find out if the addition of pembrolizumab to usual chemotherapy is better or worse than usual chemotherapy alone for non-small cell lung cancer.
Detailed Description

PRIMARY OBJECTIVES:

I. To compare the disease free survival (DFS) and overall survival (OS) (dual primary endpoints) between combination pembrolizumab plus standard of care (Arm C) versus (vs.) standard of care (Arm A) in patients with stage IB-IIIA non-small cell lung cancer.

II. To compare the DFS and OS (dual primary endpoints) between sequential pembrolizumab following standard of care (Arm B) vs. standard of care (Arm A) followed by observation in patients with stage IB-IIIA non-small cell lung cancer.

SECONDARY OBJECTIVES:

I. To compare the DFS and OS between combination pembrolizumab with standard of care (Arm C) vs. sequential standard of care followed by pembrolizumab (Arm B) in patients with stage IB-IIIA non-small cell lung cancer.

II. To compare the adverse event rates and drug discontinuation rates due to adverse events with the addition of pembrolizumab plus standard of care (combination and/or sequential; Arms B and C) vs. standard of care alone (Arm A) as well as Arm B versus Arm C in patients with stage IB-IIIA non-small cell lung cancer.

III. To compare the DFS and OS between pembrolizumab plus standard of care (combination and/or sequential; Arms B and C) vs. standard of care alone (Arm A) by PD-L1 expression status (tumor proportion score [TPS] >= 50% vs TPS < 50%) in patients with stage IB-IIIA non-small cell lung cancer.

IV. To compare the DFS and OS between pembrolizumab plus standard of care (combination and/or sequential; Arms B and C) vs. standard of care alone (Arm A) in patients with stage IB-IIIA non-small cell lung cancer that receive at least 2 cycles of initial adjuvant chemotherapy.

QUALITY OF LIFE OBJECTIVES:

I. To compare patient-reported quality of life (QOL) one year after randomization as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core (C)30 between patients randomized to receive adjuvant chemotherapy followed by pembrolizumab (Arm B), and those randomized to receive adjuvant chemotherapy + observation (Arm A).

II. To compare patient reported QOL one year after randomization as assessed by EORTC QLQ-C30 between patients randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C) and those randomized to receive adjuvant chemotherapy + observation (Arm A).

III. To compare patient-reported QOL at completion of chemotherapy as assessed by the EORTC QLQ-C30 between patients randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C) and those randomized to receive adjuvant chemotherapy + observation or adjuvant chemotherapy followed by pembrolizumab (Arms A and B combined).

IV. To present longitudinal trajectories by arm of patient-reported dyspnea and coughing as assessed by the EORTC QLQ-Lung Cancer (LC13).

CORRELATIVE SCIENCE OBJECTIVES:

I. To compare the DFS and OS with the addition of pembrolizumab (combination and/or sequential) to standard of care platinum-based adjuvant therapy (Arms B and C) vs standard of care (Arm A) in the PD-L1 subgroup of patients with PD-L1 expression status (>= 1% vs < 1%).

II. To compare the DFS and OS with the addition of pembrolizumab (combination and/or sequential) to standard of care platinum-based adjuvant therapy (Arms B and C) vs. standard of care (Arm A) by tumor mutational burden status (high vs. low) in patients with stage IB-IIIA non-small cell lung cancer.

III. To identify a cell-free deoxyribonucleic acid (cfDNA) marker associated with high-risk of recurrence and improved DFS and OS with the addition of pembrolizumab to standard adjuvant chemotherapy (Arms B and C).

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A:

INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

CONTINUANCE THERAPY: Patients then undergo observation.

ARM B:

INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

CONTINUANCE THERAPY: Patients then receive pembrolizumab intravenously (IV) over 25-40 minutes on day 1. Treatment repeats every 21 days for 17 cycles or every 6 weeks for 16 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.

ARM C:

INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice and pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.

*ACCEPTABLE REGIMENS: DOUBLET I: Patients receive cisplatin IV over 1-2 hours and pemetrexed IV over 10 minutes on day 1 of each cycle.

DOUBLET II: Patients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1 of each cycle.

DOUBLET III: Patients receive cisplatin IV over 1-2 hours on day 1 of each cycle and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 of each cycle.

DOUBLET IV: Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1 of each cycle.

After completion of study treatment, patients are followed up at 6 weeks, then every 3 months for 2 years from randomization, every 6 months for years 2-4, and then annually for up to 10 years from randomization.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Non-Small Cell Carcinoma
  • Lung Non-Small Cell Squamous Carcinoma
  • Lung Non-Squamous Non-Small Cell Carcinoma
  • Stage IB Lung Cancer AJCC v7
  • Stage IB Lung Squamous Cell Carcinoma AJCC v7
  • Stage II Lung Cancer AJCC v7
  • Stage II Lung Squamous Cell Carcinoma AJCC v7
  • Stage IIA Lung Cancer AJCC v7
  • Stage IIA Lung Squamous Cell Carcinoma AJCC v7
  • Stage IIB Lung Cancer AJCC v7
  • Stage IIB Lung Squamous Cell Carcinoma AJCC v7
  • Stage IIIA Lung Cancer AJCC v7
  • Stage IIIA Lung Squamous Cell Carcinoma AJCC v7
Intervention  ICMJE
  • Drug: Carboplatin
    Given IV
    Other Names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carboplatinum
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • Nealorin
    • Novoplatinum
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Drug: Cisplatin
    Given IV
    Other Names:
    • Abiplatin
    • Blastolem
    • Briplatin
    • CDDP
    • Cis-diammine-dichloroplatinum
    • Cis-diamminedichloridoplatinum
    • Cis-diamminedichloro Platinum (II)
    • Cis-diamminedichloroplatinum
    • Cis-dichloroammine Platinum (II)
    • Cis-platinous Diamine Dichloride
    • Cis-platinum
    • Cis-platinum II
    • Cis-platinum II Diamine Dichloride
    • Cismaplat
    • Cisplatina
    • Cisplatinum
    • Cisplatyl
    • Citoplatino
    • Citosin
    • Cysplatyna
    • DDP
    • Lederplatin
    • Metaplatin
    • Neoplatin
    • Peyrone''s Chloride
    • Peyrone''s Salt
    • Placis
    • Plastistil
    • Platamine
    • Platiblastin
    • Platiblastin-S
    • Platinex
    • Platinol
    • Platinol- AQ
    • Platinol-AQ
    • Platinol-AQ VHA Plus
    • Platinoxan
    • Platinum
    • Platinum Diamminodichloride
    • Platiran
    • Platistin
    • Platosin
  • Drug: Gemcitabine Hydrochloride
    Given IV
    Other Names:
    • dFdCyd
    • Difluorodeoxycytidine Hydrochloride
    • FF 10832
    • FF-10832
    • FF10832
    • Gemcitabine HCI
    • Gemzar
    • LY-188011
    • LY188011
  • Other: Observation
    Undergo observation
    Other Names:
    • Inspection
    • Visual Inspection
  • Drug: Paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • Bristaxol
    • Praxel
    • Taxol
    • Taxol Konzentrat
  • Biological: Pembrolizumab
    Given IV
    Other Names:
    • Keytruda
    • Lambrolizumab
    • MK-3475
    • SCH 900475
  • Drug: Pemetrexed Disodium
    Given IV
    Other Names:
    • Alimta
    • Almita
    • LY231514
    • N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Active Comparator: Arm A (platinum doublet, observation)

    INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

    CONTINUANCE THERAPY: Patients then undergo observation.

    Interventions:
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Gemcitabine Hydrochloride
    • Other: Observation
    • Drug: Paclitaxel
    • Drug: Pemetrexed Disodium
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Experimental: Arm B (platinum doublet, sequential pembrolizumab)

    INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

    CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 17 cycles or every 6 weeks for 16 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.

    Interventions:
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Gemcitabine Hydrochloride
    • Drug: Paclitaxel
    • Biological: Pembrolizumab
    • Drug: Pemetrexed Disodium
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Experimental: Arm C (platinum doublet, combination pembrolizumab)

    INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice and pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

    CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.

    Interventions:
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Gemcitabine Hydrochloride
    • Drug: Paclitaxel
    • Biological: Pembrolizumab
    • Drug: Pemetrexed Disodium
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Sands JM, Mandrekar SJ, Kozono D, Oxnard GR, Hillman SL, Wigle DA, Govindan R, Carlisle J, Gray J, Salama JK, Raez L, Ganti A, Foster N, Malik S, Bradley J, Kelly K, Ramalingam SS, Stinchcombe TE. Integration of immunotherapy into adjuvant therapy for resected non-small-cell lung cancer: ALCHEMIST chemo-IO (ACCIO). Immunotherapy. 2021 Jun;13(9):727-734. doi: 10.2217/imt-2021-0019. Epub 2021 Apr 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2020)
1263
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2025
Estimated Primary Completion Date December 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously registered to A151216
  • Central and/or local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)
  • Central and/or local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)
  • Central and/or local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263

    • Note: Local testing results of EGFR and ALK by a local Clinical Laboratory Improvement Act (CLIA) certified laboratory is acceptable. The report must indicate the result as well as the CLIA number of the laboratory that performed the assay. Local result of PD-L1 by DAKO 22C3, Dako 28-8, EIL3N or SP263 are acceptable for enrollment on A081801. Patients with local results for EGFR, ALK and PD-L1 still need to be registered to A151216 and follow all the submissions requirements but do NOT need to wait for the results to proceed to A081801 registration
  • Completely resected stage IB (>= 4 cm), II or IIIA non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 7th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2010

    • Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population
  • Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery
  • Human immunodeficiency virus (HIV)-infected patients with a history of Kaposi sarcoma and/or multicentric Castleman disease on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 8 gm/dl
  • Calculated (Calc.) creatinine clearance >= 45 mL/min
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)

Exclusion Criteria:

  • No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis
  • No prior allogeneic tissue/solid organ transplant
  • Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
  • No current pneumonitis or history of (non-infectious) pneumonitis that required steroids
  • No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible
  • No hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
  • No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
  • No known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Guam,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04267848
Other Study ID Numbers  ICMJE NCI-2020-00751
NCI-2020-00751 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
A081801 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A081801 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
URL: https://grants.nih.gov/policy/sharing.htm
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacob M Sands Alliance for Clinical Trials in Oncology
PRS Account National Cancer Institute (NCI)
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP