RECRUITING

Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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 . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.

Official Title

Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG

Quick Facts

Study Start:2024-12-11
Study Completion:2030-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06632327

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed surgically resectable stage IIA to IIIB NSCLC according to the American Joint Committee on Cancer (AJCC) 9th edition (stage IIA to IIIB NSCLC up to single station N2, according to the AJCC 8th edition)
  2. * Age ≥ 18 years
  3. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)
  4. * No prior systemic treatment for NSCLC within 5 years except stage 1 and 2 cancers treated with curative intent
  5. * No treatment for another malignancy within 3 years prior to registration, except for stage 1 or 2 cancers treated for curative intent; patients must be disease free for one year prior to registration. Patients with non-melanoma skin cancer, urothelial carcinoma in situ (Tis), noninvasive papillary carcinoma of the urinary bladder (Ta), prostatic intraepithelial neoplasia (PIN), ductal carcinoma in situ (DCIS) of the breast, or cervical intraepithelial neoplasia (CIN) of the uterine cervix are also eligible
  6. * No active autoimmune disease, interstitial lung disease, or transplant that precludes safe treatment with immune checkpoint inhibitors
  7. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kathryn Kelley, MPH
CONTACT
(773) 702-9171
kathryn.kelley@bsd.uchicago.edu

Principal Investigator

Daniel Morgensztern, MD
STUDY_CHAIR
Alliance for Clinical Trials in Oncology
Raid Aljumaily, MD
STUDY_CHAIR
Alliance for Clinical Trials in Oncology

Study Locations (Sites)

Beebe Medical Center
Lewes, Delaware, 19958
United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801
United States
Mercy Hospital
Cedar Rapids, Iowa, 52403
United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921
United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
United States

Collaborators and Investigators

Sponsor: Alliance for Clinical Trials in Oncology

  • Daniel Morgensztern, MD, STUDY_CHAIR, Alliance for Clinical Trials in Oncology
  • Raid Aljumaily, MD, STUDY_CHAIR, Alliance for Clinical Trials in Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-11
Study Completion Date2030-04-30

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2030-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Resectable Lung Non-Small Cell Carcinoma
  • Stage II Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8