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AzTrials

Lung Non-Small Cell CarcinomaPhase 2NCT04989283

Testing the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy Treatment During Radiation Therapy for Superior Sulcus Non-small Cell Lung Cancer

A Phase 2 study testing Atezolizumab, Biopsy and Biospecimen Collection in people with Lung Non-Small Cell Carcinoma and Stage IIB Lung Cancer AJCC v8, run by National Cancer Institute (NCI) at 46 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial tests the effect of atezolizumab given with usual chemotherapy during radiation therapy in treating patients with superior sulcus non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Biopsy and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
46 sitesUnited States
Study dates
9 Sep 2021to 10 May 2031
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • STEP 1 RANDOMIZATION: Participants must have histologically confirmed cT3/T4, N0/1, M0 non-small cell lung cancer (NSCLC) of the superior sulcus arising in the apex of the lung, involving apical chest wall structures (parietal pleura and beyond) above the level of the second rib
  • STEP 1 RANDOMIZATION: Participants must have eligibility affirmed by a thoracic surgeon, medical oncologist and radiation oncologist. Participant must be a candidate for surgical resection and chemoradiation therapy. The site treating investigator must sign off to indicate that eligibility has been affirmed by each specialist
  • STEP 1 RANDOMIZATION: Participants may have measurable or non-measurable disease. Measurable disease must be assessed within 28 days prior to Step 1 Randomization. Non-measurable disease must be assessed within 42 days prior to Step 1 Randomization. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form
  • STEP 1 RANDOMIZATION: Participants must have an MRI or CT scan of the brain (with contrast highly recommend) within 42 days prior to Step 1 Randomization
  • STEP 1 RANDOMIZATION: Participants must have a CT (chest with contrast highly recommended), contrast MRI (thoracic inlet), and FDG-PET/CT performed within 28 days prior to Step 1 Randomization
  • Note: DWI (Diffusion weighting imaging) is highly recommended on the MRI
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  • STEP 1 RANDOMIZATION: Participants may participate in concomitant non-therapeutic trials (e.g., palliative care assessment or quality of life studies)
  • STEP 1 RANDOMIZATION: History and physical exam must be obtained within 28 days of Step 1 Randomization
  • STEP 1 RANDOMIZATION: Participants must have Zubrod performance status of 0-1 documented within 28 days prior to Step 1 Randomization
  • STEP 1 RANDOMIZATION: Participants must be >= 18 years old
  • STEP 1 RANDOMIZATION: Leukocytes >= 3,000/uL (within 28 days prior to Step 1 Randomization)
  • STEP 1 RANDOMIZATION: Absolute neutrophil count >= 1,500/uL (within 28 days prior to Step 1 Randomization)
  • STEP 1 RANDOMIZATION: Platelets >= 100,000/uL (within 28 days prior to Step 1 Randomization)
  • STEP 1 RANDOMIZATION: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to Step 1 Randomization)
  • STEP 1 RANDOMIZATION: Participants with known Gilbert disease: total bilirubin =< 3 x (ULN) (within 28 days prior to Step 1 Randomization)
  • STEP 1 RANDOMIZATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to Step 1 Randomization)
  • STEP 1 RANDOMIZATION: Hemoglobin >= 9 g/dL (within 28 days prior to Step 1 Randomization)
  • STEP 1 RANDOMIZATION: Participants must not have higher than grade 2 hypercalcemia prior to Step I Randomization
  • STEP 1 RANDOMIZATION: Participants must have a serum creatinine =< the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to Step 1 Randomization
  • STEP 1 RANDOMIZATION: Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have undetectable viral load test within 6 months prior to Step 1 Randomization
  • STEP 1 RANDOMIZATION: Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to Step 1 Randomization
  • STEP 1 RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within in 28 days prior to Step 1 Randomization
  • STEP 1 RANDOMIZATION: Participants of reproductive potential must have a negative serum pregnancy test within 14 days prior to Step 1 Randomization
  • STEP 1 RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking
  • STEP 1 RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
  • STEP 2 SURGERY: Participants must have a CT scan of the chest with contrast, FDG-PET/CT scan and MRI scan of the thoracic inlet (with intravenous contrast and DWI highly recommended) within 28 days prior to Step 2 Registration
  • STEP 2 SURGERY: Participants must be evaluated for appropriateness of surgery by a thoracic surgeon within 6 weeks after completion of neoadjuvant therapy prior to Step 2 Registration
  • STEP 2 SURGERY: Participant's surgery must occur between 21 and 90 days following the end of participant's final cycle of chemotherapy +/- atezolizumab
  • STEP 2 SURGERY: Participants must have received at least two cycles of all assigned protocol drugs during neoadjuvant protocol treatment and must have received at least 45 GY RT of the planned 61.2 GY RT during neoadjuvant protocol treatment
  • STEP 2 SURGERY: Participants must have a Zubrod Performance Status of 0-1 documented within 28 days prior to Step 2 Registration
  • STEP 2 SURGERY: Participants must have postoperative predicted forced expiratory volume in 1 second (FEV1) > 35% and postoperative predicted diffusion capacity of the lung for carbon monoxide (DLCO) > 35%. Pulmonary function tests to ascertain these values must be obtained within 28 days prior to Step 2 Registration
  • STEP 3 MAINTENANCE THERAPY (ARM 1 ONLY): Participants must have received surgical resection of the lung cancer and side effects must have recovered to =< grade 2 within 42 days after surgery and prior to Step 3 Registration
  • STEP 3 MAINTENANCE THERAPY (ARM 1 ONLY): Participants must have a Zubrod Performance Status of 0-1 documented within 28 days prior to Step 3 Registration
  • STEP 3 MAINTENANCE THERAPY (ARM 1 ONLY): Leukocytes >= 3,000/uL (within 28 days prior to Step 3 Registration)
  • STEP 3 MAINTENANCE THERAPY (ARM 1 ONLY): Absolute neutrophil count >= 1,000/uL (within 28 days prior to Step 3 Registration)
  • STEP 3 MAINTENANCE THERAPY (ARM 1 ONLY): Platelets >= 100,000/uL (within 28 days prior to Step 3 Registration)
  • STEP 3 MAINTENANCE THERAPY (ARM 1 ONLY): Hemoglobin >= 9 g/dL (within 28 days prior to Step 3 Registration)
  • STEP 3 MAINTENANCE THERAPY (ARM 1 ONLY): Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to Step 3 Registration)
  • STEP 3 MAINTENANCE THERAPY (ARM 1 ONLY): AST and ALT =< 3 x institutional ULN (within 28 days prior to Step 3 Registration)
  • STEP 3 MAINTENANCE THERAPY (ARM 1 ONLY): Participants must have adequate kidney function defined as creatinine =< 1.5 x ULN documented within 28 days prior to Step 3 Registration

Who cannot join

  • STEP 1 RANDOMIZATION: Participants must not have had prior therapy for this cancer including surgery, chemotherapy, immunotherapy, targeted therapy agent, and/or radiation therapy
  • STEP 1 RANDOMIZATION: Participants must not have undergone prior radiation to overlapping regions of planned protocol radiation therapy (RT) treatment area
  • STEP 1 RANDOMIZATION: Participants must not have had prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • STEP 1 RANDOMIZATION: Participants must not have had prior treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks prior to Step 1 Randomization
  • STEP 1 RANDOMIZATION: Participants must not have a known allergy or hypersensitivity to any component of the carboplatin, pemetrexed, cisplatin, etoposide and paclitaxel formulation
  • STEP 1 RANDOMIZATION: Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 3 months, or serious uncontrolled cardiac arrhythmia
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  • STEP 1 RANDOMIZATION: Participants must not have known active tuberculosis (TB)
  • STEP 1 RANDOMIZATION: Participants must not have uncontrolled non-malignant pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (more than once a month). Note: Participants with indwelling catheters (e.g., PleurX [registered trademark]) are allowed
  • STEP 1 RANDOMIZATION: Patients must not have undergone prior allogeneic stem cell transplantation or prior solid organ transplantation
  • STEP 1 RANDOMIZATION: Participants must NOT have a history of severe allergic, anaphylactic, or other known hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • STEP 1 RANDOMIZATION: Participants must NOT have a known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • STEP 1 RANDOMIZATION: Participants must not have severe or active infections within 28 days prior to Step 1 Randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • STEP 1 RANDOMIZATION: Participants must not have active autoimmune disease requiring therapy within the past 6 months. Participants must not have active autoimmune disease that has required systemic treatment within the past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. This protocol includes an immunotherapy agent which can precipitate known autoimmune diseases
  • STEP 1 RANDOMIZATION: Participants must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (e.g., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis. This protocol includes an immunotherapy agent which can precipitate known pneumonitis
  • STEP 1 RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • STEP 1 RANDOMIZATION: Participants must not have received a live attenuated vaccination within 28 days prior to Step 1 Randomization. All coronavirus disease 2019 (COVID-19) vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable
  • STEP 1 RANDOMIZATION: Participants must not have had a major surgery within 14 days prior to Step 1 Randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
  • STEP 1 RANDOMIZATION: Participants must not be pregnant or nursing due to carcinogenic and teratogenic effects of treatment. Women/men of reproductive potential must have agreed to use an effective contraceptive method while on study treatment and for 5 months after the last dose. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined, he/she is responsible for beginning contraceptive measures

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

United States46 sites

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Baptist Memorial Hospital and Cancer Center-Union County

    New Albany, Mississippi, 38652

  • Mount Sinai Chelsea

    New York, New York, 10011

  • Mount Sinai Hospital

    New York, New York, 10029

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Saint Alphonsus Medical Center-Ontario

    Ontario, Oregon, 97914

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Norris Cotton Cancer Center-North

    Saint Johnsbury, Vermont, 05819

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, 45069

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: NASSIST (Neoadjuvant Chemoradiation +/- Immunotherapy Before Surgery for Superior Sulcus Tumors): A Randomized Phase II Trial of Trimodality +/- Atezolizumab in Resectable Superior Sulcus Non-Small Cell Lung Cancer

This phase II trial tests the effect of atezolizumab given with usual chemotherapy during radiation therapy in treating patients with superior sulcus non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, 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, such as cisplatin, carboplatin, etoposide, paclitaxel and pemetrexed, 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. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving atezolizumab with usual chemotherapy and radiation therapy may lower the chance of the tumor from growing or spreading.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare the pathologic complete response (pCR) by local review between participants randomized to conventional trimodality therapy, with or without atezolizumab.

SECONDARY OBJECTIVES:

  1. To compare event-free survival (EFS) between the arms. II. To compare overall survival (OS) between the arms. III. To compare surgical resection rate and complete resection (R0) rate between the arms.

IV. To evaluate progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 among participants who do not undergo surgical resection, by treatment arm.

  1. To compare the frequency and severity of toxicities between the arms.

ADDITIONAL OBJECTIVES:

  1. To bank blood and tissue for future research. II. To evaluate the association between major pathologic response (MPR), as defined by the International Association for the Study of Lung Cancer (IASLC), and survival outcomes (OS, PFS).

III. To evaluate the association between pCR by centralized review and survival outcomes (OS, PFS).

IV. Evaluate the changes in fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) metrics (e.g., standardized uptake value [SUV] maximum [max], SUVpeak, SUVmax tumor-to-liver, SUVpeak tumor-to-liver, metabolic tumor volume, total lesion glycolysis, etc.) in participants randomized to receive trimodality therapy alone or in combination with atezolizumab and to evaluate the association with pCR.

  1. Evaluate the extent to which the changes in diffusion weighted imaging (DWI)-magnetic resonance imagining (MRI) metrics (e.g., mean apparent diffusion coefficient or apparent diffusion coefficient [ADC] for the primary tumor, etc.) are associated with pCR in participants randomized to receive trimodality therapy alone or in combination with atezolizumab.

VI. Evaluate the extent to which changes in computed tomography (CT) tumor volume, unidimensional lesion changes per RECIST 1.1 and bidimensional lesion changes per World Health Organization (WHO) criteria are associated with pCR in participants randomized to receive trimodality therapy alone or in combination with atezolizumab.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Patients also receive one of the chemotherapy combinations below depending on their previous therapy and disease. Between the first day of chemotherapy and the first day of cycle 2 of chemotherapy, patients undergo external beam radiation therapy 5 days per week. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 21 and 90 days after treatment, patients undergo surgery. Within 42 days after completion of surgery, patients then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive one of the chemotherapy combinations below depending on their previous therapy and disease. Between the first day of chemotherapy and the first day of cycle 2 of chemotherapy, patients also undergo external beam radiation therapy 5 days per week. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 21 and 90 days after treatment, patients undergo surgery.

Patients receive one of the chemotherapy combinations:

  1. Cisplatin IV over 2 hours on day 1 and etoposide IV over 30-60 minutes on days 1-3.
  2. Carboplatin IV over 60 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3.
  3. Paclitaxel IV over 3 hours and carboplatin IV over 60 minutes on day 1. Patients with non-squamous NSCLC may receive one of the following combinations:
  4. Pemetrexed IV over 10 minutes and carboplatin IV over 60 minutes on day 1.
  5. Pemetrexed IV over 10 minutes and cisplatin IV over 2 hours on day 1.

Patients may undergo a PET scan, CT scan, and MRI on study. Patients also undergo tumor biopsies and blood sample collection throughout the trial.

Being tested
Atezolizumab, Biopsy, Biospecimen Collection, Carboplatin, Cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabBiological

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given IV

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT scan

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy

    Undergo external beam radiation therapy

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • PemetrexedDrug

    Also called MTA, Multitargeted Antifolate, Pemfexy

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT scan

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgery

Study groups in NCT04989283
Study groupRoleWhat they receive
Arm I (atezolizumab, chemotherapy, RT, surgery)ExperimentalPatients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive one of the chemotherapy combinations below depending on their previous therapy and disease. Between the first day of chemotherapy and the first day of cycle 2 of chemotherapy, patients undergo external beam radiation therapy 5 days per week. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 21 and 90 days after treatment, patients undergo surgery. Within 42 days after completion of surgery, patients then receive atezolizumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo a PET scan, CT scan, and MRI on study. Patients also undergo tumor biopsies and blood sample collection throughout the trial.
Receives: Biological: Atezolizumab; Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Etoposide; Radiation: External Beam Radiation Therapy; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Drug: Pemetrexed; Procedure: Positron Emission Tomography; Procedure: Therapeutic Conventional Surgery
Arm II (chemotherapy, RT, surgery)Active comparatorPatients receive one of the chemotherapy combinations below depending on their previous therapy and disease. Between the first day of chemotherapy and the first day of cycle 2 of chemotherapy, patients also undergo external beam radiation therapy 5 days per week. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 21 and 90 days after treatment, patients undergo surgery. Patients may undergo a PET scan, CT scan, and MRI on study. Patients also undergo tumor biopsies and blood sample collection throughout the trial.
Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Drug: Etoposide; Radiation: External Beam Radiation Therapy; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Drug: Pemetrexed; Procedure: Positron Emission Tomography; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic complete response (pCR) by local review

    Measured: Up to 6 years

Secondary outcomes (6)

  1. Event-free survival (EFS)

    Defined as From date of Step1 Randomization to date of first documentation of progression that renders participant unable to receive planned protocol surgery, off protocol therapy for any reason without subsequent protocol surgery, relapse after surgery, symptomatic deterioration or death due to any reason, whichever comes first. The primary analysis of EFS will be done using a 1-sided 15% level log-rank test. Will be estimated using the method of Kaplan-Meier. 95% confidence intervals for the medians will be constructed using the method of Brookmeyer-Crowley. Fine-Gray method will be used for a competing risk analysis.

    Measured: Up to 6 years

  2. Overall survival (OS)

    Will be estimated using the method of Kaplan-Meier. 95% confidence intervals for the medians will be constructed using the method of Brookmeyer-Crowley.

    Measured: From date of Step 1 Randomization to date of death due to any cause, assessed up to 6 years

  3. Surgical resection rate

    Measured: Up to 6 years

  4. Complete resection (R0) rate

    Measured: Up to 6 years

  5. Progression-free survival (PFS)

    Will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be estimated using the method of Kaplan-Meier. 95% confidence intervals for the medians will be constructed using the method of Brookmeyer-Crowley.

    Measured: From date of Step 1 Randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 years

  6. Incidence of adverse events

    Will compare the frequency and severity of toxicities between the arms.

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2021
  2. Study start9 Sep 2021 (estimated)
  3. Primary completion10 May 2031 (estimated)
  4. Study completion10 May 2031 (estimated)

Why it stopped: Due to no accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04989283
Sponsor's protocol ID
NCI-2021-08318
Other IDs
NCI-2021-08318, S1934, S1934, U10CA180888
Status last verified
Sep 2023
First submitted
3 Aug 2021
Last updated
26 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: "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."

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Biopsy and Biospecimen Collection in people with Lung Non-Small Cell Carcinoma and Stage IIB Lung Cancer AJCC v8, run by National Cancer Institute (NCI) at 46 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response (pCR) by local review (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04989283.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.

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