Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)

Status: Recruiting
Location: See all (153) locations...
Intervention Type: Procedure, Biological, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)

• Participants must have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network \[NCCN\] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.

⁃ Note the NCCN guidelines: N1 and N2 node resection and mapping is a routine component of lung cancer resections. It is recommended at a minimum one N1 and three N2 stations is sampled or complete lymph node dissection. Formal ipsilateral mediastinal lymph node dissection is indicated for participants undergoing resection for N2 disease

• Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review

• Participants must have a PD-L1 status result (e.g. \[\< 1% versus \>= 1% or unknown\])

• Participants must not have known EGFR mutations, or ALK gene fusion

• Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines

• Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study

• Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization

• Participants must not have medical contraindications or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy

• Participants must not have received post-operative radiation therapy (PORT) for NSCLC

• Participants must not have any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator

• Participant must be ≥ 18 years old at time of study entry

• Participants must have body weight \> 30 kg

• Participant must have Zubrod performance status of 0-2

• Participant must have a complete medical history and physical exam within 28 days prior to randomization

• Hemoglobin \> 9.0 g/dL (within 28 days prior to randomization)

• Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to randomization)

• Platelets ≥ 100 x 10\^3/uL (within 28 days prior to randomization)

• Total bilirubin ≤ 1 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to randomization)

• Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)

• Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx

• Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator

• Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization

• Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated

• Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated

• Participants must not have had an organ transplant

• 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

• Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed

• Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of reproductive potential. In addition to routine contraceptive methods, effective contraception also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy

• Participants must not have received a live or live attenuated vaccine within 28 days prior randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and coronavirus disease 19 (COVID-19) vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed

• Participants must be offered the opportunity to participate in specimen banking

• Participants who can complete FACT-L, FACT-BRM, and PRO-CTCAE questionnaires forms in English, or Spanish must agree to participate in the patient-reported outcome study

• NOTE: 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

• 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

Locations
United States
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
RECRUITING
Jonesboro
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Torrance Memorial Physician Network - Cancer Care
RECRUITING
Torrance
Colorado
Saint Mary's Hospital and Regional Medical Center
RECRUITING
Grand Junction
Connecticut
Hartford Hospital
RECRUITING
Hartford
Midstate Medical Center
RECRUITING
Meriden
The Hospital of Central Connecticut
RECRUITING
New Britain
Delaware
Helen F Graham Cancer Center
RECRUITING
Newark
Medical Oncology Hematology Consultants PA
RECRUITING
Newark
Hawaii
Hawaii Cancer Care - Westridge
RECRUITING
‘aiea
The Queen's Medical Center - West Oahu
RECRUITING
‘ewa Beach
Hawaii Cancer Care Inc - Waterfront Plaza
RECRUITING
Honolulu
Queen's Cancer Cenrer - POB I
RECRUITING
Honolulu
Queen's Cancer Center - Kuakini
RECRUITING
Honolulu
Queen's Medical Center
RECRUITING
Honolulu
Iowa
Mary Greeley Medical Center
RECRUITING
Ames
McFarland Clinic - Ames
RECRUITING
Ames
McFarland Clinic - Boone
RECRUITING
Boone
McFarland Clinic - Trinity Cancer Center
RECRUITING
Fort Dodge
McFarland Clinic - Jefferson
RECRUITING
Jefferson
McFarland Clinic - Marshalltown
RECRUITING
Marshalltown
Idaho
Saint Luke's Cancer Institute - Boise
RECRUITING
Boise
Kootenai Health - Coeur d'Alene
RECRUITING
Coeur D'alene
Saint Luke's Cancer Institute - Fruitland
RECRUITING
Fruitland
Saint Luke's Cancer Institute - Meridian
RECRUITING
Meridian
Saint Luke's Cancer Institute - Nampa
RECRUITING
Nampa
Kootenai Clinic Cancer Services - Post Falls
RECRUITING
Post Falls
Kootenai Clinic Cancer Services - Sandpoint
RECRUITING
Sandpoint
Illinois
Northwestern University
RECRUITING
Chicago
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Northwestern Medicine Glenview Outpatient Center
RECRUITING
Glenview
Northwestern Medicine Grayslake Outpatient Center
RECRUITING
Grayslake
Northwestern Medicine Lake Forest Hospital
RECRUITING
Lake Forest
Loyola University Medical Center
RECRUITING
Maywood
Northwestern Medicine Oak Brook
RECRUITING
Oak Brook
Northwestern Medicine Orland Park
RECRUITING
Orland Park
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Kansas
HaysMed
RECRUITING
Hays
The University of Kansas Cancer Center - Olathe
RECRUITING
Olathe
University of Kansas Health System Saint Francis Campus
RECRUITING
Topeka
Massachusetts
Lahey Hospital and Medical Center
RECRUITING
Burlington
Lahey Medical Center-Peabody
RECRUITING
Peabody
Baystate Medical Center
RECRUITING
Springfield
Maryland
UPMC Western Maryland
RECRUITING
Cumberland
Michigan
Bronson Battle Creek
RECRUITING
Battle Creek
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
OSF Saint Francis Hospital and Medical Group
RECRUITING
Escanaba
Cancer Hematology Centers - Flint
RECRUITING
Flint
Genesee Hematology Oncology PC
SUSPENDED
Flint
Genesys Hurley Cancer Institute
RECRUITING
Flint
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITING
Grand Rapids
Trinity Health Grand Rapids Hospital
RECRUITING
Grand Rapids
Bronson Methodist Hospital
RECRUITING
Kalamazoo
West Michigan Cancer Center
RECRUITING
Kalamazoo
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Trinity Health Muskegon Hospital
RECRUITING
Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital
RECRUITING
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
RECRUITING
Norton Shores
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
Corewell Health Reed City Hospital
RECRUITING
Reed City
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
RECRUITING
Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
RECRUITING
Saint Joseph
Munson Medical Center
RECRUITING
Traverse City
University of Michigan Health - West
RECRUITING
Wyoming
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Minneapolis VA Medical Center
RECRUITING
Minneapolis
Essentia Health Sandstone
RECRUITING
Sandstone
Essentia Health Virginia Clinic
RECRUITING
Virginia
Missouri
Mercy Oncology and Hematology - Clayton-Clarkson
RECRUITING
Ballwin
Mercy Hospital Saint Louis
RECRUITING
St Louis
Mercy Hospital South
RECRUITING
St Louis
Mississippi
Baptist Memorial Hospital and Cancer Center-Golden Triangle
RECRUITING
Columbus
Baptist Cancer Center-Grenada
RECRUITING
Grenada
Baptist Memorial Hospital and Cancer Center-Union County
RECRUITING
New Albany
Baptist Memorial Hospital and Cancer Center-Oxford
RECRUITING
Oxford
Baptist Memorial Hospital and Cancer Center-Desoto
RECRUITING
Southhaven
Montana
Community Hospital of Anaconda
RECRUITING
Anaconda
Billings Clinic Cancer Center
RECRUITING
Billings
Saint Vincent Frontier Cancer Center
RECRUITING
Billings
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Logan Health Medical Center
RECRUITING
Kalispell
Community Medical Center
RECRUITING
Missoula
North Carolina
Duke Cancer Center Cary
RECRUITING
Cary
Duke University Medical Center
RECRUITING
Durham
FirstHealth of the Carolinas-Moore Regional Hospital
RECRUITING
Pinehurst
Duke Cancer Center Raleigh
RECRUITING
Raleigh
North Dakota
Sanford Bismarck Medical Center
RECRUITING
Bismarck
Essentia Health Cancer Center-South University Clinic
RECRUITING
Fargo
Sanford Broadway Medical Center
RECRUITING
Fargo
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Montefiore Medical Center - Moses Campus
RECRUITING
The Bronx
Montefiore Medical Center-Einstein Campus
RECRUITING
The Bronx
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Providence Hood River Memorial Hospital
RECRUITING
Hood River
Providence Newberg Medical Center
RECRUITING
Newberg
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
RECRUITING
Allentown
Lehigh Valley Hospital - Muhlenberg
RECRUITING
Bethlehem
Bryn Mawr Hospital
RECRUITING
Bryn Mawr
Pocono Medical Center
RECRUITING
East Stroudsburg
UPMC Hillman Cancer Center Erie
RECRUITING
Erie
UPMC Cancer Centers - Arnold Palmer Pavilion
RECRUITING
Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
RECRUITING
Harrisburg
Lehigh Valley Hospital-Hazleton
RECRUITING
Hazleton
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
RECRUITING
Mechanicsburg
Riddle Memorial Hospital
RECRUITING
Media
UPMC Hillman Cancer Center - Monroeville
RECRUITING
Monroeville
Paoli Memorial Hospital
RECRUITING
Paoli
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
Reading Hospital
RECRUITING
West Reading
Lankenau Medical Center
RECRUITING
Wynnewood
South Carolina
Prisma Health Cancer Institute - Spartanburg
RECRUITING
Boiling Springs
Prisma Health Cancer Institute - Easley
RECRUITING
Easley
Prisma Health Cancer Institute - Butternut
RECRUITING
Greenville
Prisma Health Cancer Institute - Eastside
RECRUITING
Greenville
Prisma Health Cancer Institute - Faris
RECRUITING
Greenville
Prisma Health Cancer Institute - Greer
RECRUITING
Greer
Prisma Health Cancer Institute - Seneca
RECRUITING
Seneca
South Dakota
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
RECRUITING
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
RECRUITING
Memphis
Washington
Swedish Cancer Institute-Edmonds
RECRUITING
Edmonds
Swedish Cancer Institute-Issaquah
RECRUITING
Issaquah
Swedish Medical Center-First Hill
RECRUITING
Seattle
Wisconsin
Langlade Hospital and Cancer Center
RECRUITING
Antigo
Duluth Clinic Ashland
RECRUITING
Ashland
Saint Vincent Hospital Cancer Center at Saint Mary's
RECRUITING
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
Gundersen Lutheran Medical Center
RECRUITING
La Crosse
Aspirus Medford Hospital
RECRUITING
Medford
Saint Vincent Hospital Cancer Center at Oconto Falls
RECRUITING
Oconto Falls
Aspirus Cancer Care - James Beck Cancer Center
RECRUITING
Rhinelander
Saint Vincent Hospital Cancer Center at Sheboygan
RECRUITING
Sheboygan
Sheboygan Physicians Group
RECRUITING
Sheboygan
Aspirus Cancer Care - Stevens Point
RECRUITING
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
RECRUITING
Sturgeon Bay
Aspirus Regional Cancer Center
RECRUITING
Wausau
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING
Wisconsin Rapids
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2039-07-15
Participants
Target number of participants: 306
Treatments
Experimental: Arm I (durvalumab)
Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT and blood sample collection throughout the trial.
Active_comparator: Arm II (active surveillance)
Patients undergo active surveillance for 12 months on study. Patients undergo CT and blood sample collection throughout the trial.
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov