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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04310020
Other study ID # NCI-2020-01543
Secondary ID NCI-2020-01543S1
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 13, 2021
Est. completion date September 1, 2024

Study information

Verified date May 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial studies the side effects of radiation therapy followed by atezolizumab in treating patients with stage II or III non-small cell lung cancer. Hyperfractionated radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. 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. The purpose of this study is to test the safety and effectiveness of radiation therapy followed by atezolizumab and find out what side effects, if any, it has on patient's non-small cell lung cancer.


Description:

PRIMARY OBJECTIVE: I. To evaluate the rate of grade 3-5 treatment-related adverse events (TRAEs) in patients who are not candidates for surgery or concurrent chemoradiation and who have either performance status 0-2 and stage II or performance status 2 and stage III non-small cell lung cancer (NSCLC), treated with hypofractionated thoracic radiotherapy followed by atezolizumab. SECONDARY OBJECTIVES: I. To evaluate response rate (confirmed and unconfirmed, complete and partial by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) from Registration Step 2 in the subset of patients with measurable disease. II. To evaluate response rate (confirmed and unconfirmed, complete and partial by RECIST 1.1) during radiation therapy in the subset of patients with measurable disease. III. To evaluate progression free survival (PFS) from Registration Step 2 by RECIST 1.1. IV. To evaluate overall survival (OS) from Registration Step 2. V. To evaluate the frequency and severity of toxicities. ADDITIONAL OBJECTIVE: I. To bank blood and archival tissue for future research. OUTLINE: RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI throughout the study, as well as blood sample collection on study. After completion of study treatment, patients are followed up at 6 weeks, every 12 months for the 1 year, then every 6 months until 3 years after study start.


Recruitment information / eligibility

Status Recruiting
Enrollment 47
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - REGISTRATION STEP 1: Participants must have pathologic (cytological or histological) proof of non-small cell lung cancer (NSCLC) - REGISTRATION STEP 1: Participants must have stage III NSCLC with Zubrod performance status of 2 or stage II NSCLC with Zubrod performance status of 0-2 - REGISTRATION STEP 1: Participants must not be candidates for surgical resection in the opinion of the treating investigator. Participants whose disease was previously resected must have experienced local or regional recurrence at least 12 months after resection - REGISTRATION STEP 1: Participants must not be candidates for concurrent chemoradiation in the opinion of the treating investigator - REGISTRATION STEP 1: Participants must have measurable or non-measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to Registration Step 1. Non-measurable disease must be assessed within 42 days prior to Step 1 registration. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1) - REGISTRATION STEP 1: Participants must have an MRI or CT scan of the brain with contrast within 28 days prior to Registration Step 1 - REGISTRATION STEP 1: Participants' disease must fit within the radiation constraints in the opinion of a local radiation oncologist - REGISTRATION STEP 1: Participants may have received prior treatment for their lung cancer, including surgery, chemotherapy, targeted agents, and/or radiation treatment. At least 12 months must have elapsed since last treatment - REGISTRATION STEP 1: Participants may have had prior radiation therapy as long as the irradiated area does not overlap with the radiation field targeted for this study - REGISTRATION STEP 1: Participants must have recovered from any adverse effects of prior major surgery to the satisfaction of the treating physician. Biopsies and central IV access placement are not considered major surgery - REGISTRATION STEP 1: Absolute neutrophil count (ANC) >= 1500/mcl (obtained within 28 days prior to Registration Step 1) - REGISTRATION STEP 1: Platelet count >= 100,000/mcl (obtained within 28 days prior to Registration Step 1) - REGISTRATION STEP 1: Hemoglobin >= 9 grams/dL (obtained within 28 days prior to Registration Step 1) - REGISTRATION STEP 1: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 1) - REGISTRATION STEP 1: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (obtained within 28 days prior to Registration Step 1) - REGISTRATION STEP 1: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 40 mL/min (obtained within 28 days prior to Registration Step 1) - REGISTRATION STEP 1: Participants must have percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) of at least 50% documented within 90 days prior to Registration Step 1 - REGISTRATION STEP 1: Patient must not have had a prior history of interstitial lung disease or > grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version 5) pneumonitis - REGISTRATION STEP 1: Participants must not have active autoimmune disease requiring therapy within the past 6 months - REGISTRATION STEP 1: Participants must not have an active infection requiring therapy - REGISTRATION STEP 1: Participants must not be pregnant or nursing because atezolizumab has not been studied in pregnant or nursing women and the mechanism of action is expected to cause fetal harm. Women/men of reproductive potential must have agreed to use an effective contraceptive method while on protocol treatment and for five months after last dose of atezolizumab. 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 patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - REGISTRATION STEP 1: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Registration Step 1 - REGISTRATION STEP 1: Patient must be tested for hepatitis B within 28 days prior to Registration Step 1. Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection. Patients may have past or resolved HBV infection. Active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test. Past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test - REGISTRATION STEP 1: Patients must not have active hepatitis C virus (HCV) infection. Active HCV is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test. Patient must have an HCV antibody test within 28 days prior to Registration Step 1. If the HCV antibody test is positive, the patient must also have an HCV quantitative RNA test within 28 days prior to Registration Step 1 - REGISTRATION STEP 1: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years. Participants with localized prostate cancer who are being followed by an active surveillance program are also eligible - REGISTRATION STEP 1: Participants must be offered optional participation in banking of specimens for future research - REGISTRATION STEP 1: Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - REGISTRATION STEP 1: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - REGISTRATION STEP 2: Participants must be registered to Step 2 within 42 days after completion of radiation treatment. Participants must have received at least 44 Gy of radiation treatment - REGISTRATION STEP 2: Participants must have no evidence of progression per RECIST 1.1 on CT scan of the chest, abdomen, and pelvis performed between 2 and 5 weeks after completion of radiation therapy - REGISTRATION STEP 2: Any toxicities from radiation therapy must have resolved to < grade 2 - REGISTRATION STEP 2: Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL (obtained within 28 days prior to Registration Step 2) - REGISTRATION STEP 2: Platelet count >= 100 x 10^3/uL (obtained within 28 days prior to Registration Step 2) - REGISTRATION STEP 2: Hemoglobin >= 9 grams/dL (obtained within 28 days prior to Registration Step 2) - REGISTRATION STEP 2: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 2) - REGISTRATION STEP 2: AST and ALT =< 2.5 x IULN (obtained within 28 days prior to Registration Step 2) - REGISTRATION STEP 2: Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 40 mL/min (obtained within 28 days prior to Registration Step 2) - REGISTRATION STEP 2: Participants must not have received steroids in doses of more than prednisone 10 mg daily or equivalent within 14 days prior to Registration Step 2 - REGISTRATION STEP 2: Participants must not have received a live vaccine within 28 days prior to Registration Step 2

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atezolizumab
Given IV
Procedure:
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Radiation:
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Procedure:
Magnetic Resonance Imaging
Undergo MRI

Locations

Country Name City State
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Mission Cancer and Blood - Ankeny Ankeny Iowa
United States Ascension Saint Elizabeth Hospital Appleton Wisconsin
United States Augusta University Medical Center Augusta Georgia
United States Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida
United States Beverly Hospital Beverly Massachusetts
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield Wisconsin
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Illinois CancerCare-Carthage Carthage Illinois
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Saint Mary's Hospital Centralia Illinois
United States Jesse Brown Veterans Affairs Medical Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Ascension Calumet Hospital Chilton Wisconsin
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee
United States Greater Regional Medical Center Creston Iowa
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern Simmons Cancer Center - RedBird Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle at The Riverfront Danville Illinois
United States Dayton Physician LLC - Englewood Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Premier Blood and Cancer Center Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Porter Adventist Hospital Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States UPMC Hillman Cancer Center Erie Erie Pennsylvania
United States Illinois CancerCare-Eureka Eureka Illinois
United States Parkland Health Center - Farmington Farmington Missouri
United States UPMC Cancer Center at UPMC Horizon Farrell Pennsylvania
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Ascension Saint Francis - Reiman Cancer Center Franklin Wisconsin
United States Ascension Southeast Wisconsin Hospital - Franklin Franklin Wisconsin
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Benefis Sletten Cancer Institute Great Falls Montana
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Miami Valley Cancer Care and Infusion Greenville Ohio
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Island Urology Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Kalispell Regional Medical Center Kalispell Montana
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States Saint Joseph Hospital Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Littleton Adventist Hospital Littleton Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin
United States Mount Sinai Medical Center Miami Beach Florida
United States Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin
United States Ascension Saint Francis Hospital Milwaukee Wisconsin
United States Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee Wisconsin
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States UPMC Hillman Cancer Center - New Castle New Castle Pennsylvania
United States CTCA at Southeastern Regional Medical Center Newnan Georgia
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States HSHS Saint Elizabeth's Hospital O'Fallon Illinois
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Ascension Mercy Hospital Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Parker Adventist Hospital Parker Colorado
United States Lahey Medical Center-Peabody Peabody Massachusetts
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania
United States UPMC-Saint Margaret Pittsburgh Pennsylvania
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Illinois CancerCare-Princeton Princeton Illinois
United States Ascension All Saints Hospital Racine Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Illinois CancerCare - Washington Washington Illinois
United States UPMC Cancer Center-Washington Washington Pennsylvania
United States UPMC Washington Hospital Radiation Oncology Washington Pennsylvania
United States Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa Wisconsin
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Winchester Hospital Winchester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of grade 3-5 adverse events Individual toxicities with possible, probable or likely attribution to treatment along with the overall rate of grade 3, 4 or 5 toxicities attributable to treatment will be summarized. From baseline, until 180 days from Step 2 registration
Secondary Incidence of adverse events Individual toxicities with possible, probable or likely attribution to treatment along with the overall rate of grade 3, 4 or 5 toxicities attributable to treatment will be summarized. Up to 3 years
Secondary Response rate (confirmed and unconfirmed, complete and partial by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) in the subset of patients with measurable disease (Registration Step 2) Binary endpoints will be summarized as proportions with 95% Clopper-Pearson confidence intervals. After atezolizumab treatment
Secondary Response rate (confirmed and unconfirmed, complete and partial by RECIST 1.1) in the subset of patients with measurable disease (Registration Step 1) Binary endpoints will be summarized as proportions with 95% Clopper-Pearson confidence intervals. During radiation therapy
Secondary Progression-free survival Estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley. From date of Step 2 registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Secondary Overall survival Estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley. From date of Step 2 registration to date of death due to any cause, assessed up to 3 years
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