RECRUITING

Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)

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 II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.

Official Title

A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

Quick Facts

Study Start:2025-07-11
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06616584

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. * Participants must have been assigned to S1800E by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800E is determined by the LUNGMAP protocol
  2. * Participants must have measurable or non-measurable disease documented by CT or MRI. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to randomization. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to randomization. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Participants whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration
  3. * Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to randomization
  4. * Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage I-III disease:
  5. * If they experienced disease progression within (≤) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease
  6. * If they experienced disease progression more than (\>) 365 days from initiation (cycle 1 day 1) or anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advance disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
  7. * Participants must have experienced disease progression (in the opinion of the treating investigator) more than (\>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy
  8. * Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating investigator) on the anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease
  9. * Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen
  10. * Participants with a known sensitizing molecular alteration for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met
  11. * Participants must have recovered (≤ grade 1) from any side effects from the most recent anti-cancer treatment prior to randomization
  12. * Participants must not have received prior therapy with docetaxel for this disease
  13. * Participants must not have received any palliative radiation therapy within 14 days (or palliative bone radiation therapy within 7 days) prior to randomization
  14. * Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, or biologic therapy for cancer treatment while receiving treatment on this study
  15. * Participants must not have undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Participants must not have postoperative bleeding complications or wound complications from a surgical procedure performed within 2 months prior to randomization. The participant must not have elective or planned major surgery to be performed during the course of this study
  16. * Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to randomization)
  17. * Hemoglobin ≥ 9.0 g/dL (within 28 days prior to randomization)
  18. * Platelets ≥ 100 x 10\^3/uL (within 28 days prior to randomization)
  19. * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
  20. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN
  21. * Participants must have a creatinine ≤ the institutional (I)ULN 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 randomization
  22. * Participants must have a urinary protein test performed within 28 days prior to randomization
  23. * Participants' most recent Zubrod/Eastern Cooperative Oncology Group (ECOG) performance status must be 0-1 and be documented within 28 days prior to randomization
  24. * Participants must have a completed medical history and physical exam within 28 days prior to randomization
  25. * Participants with evidence 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 by the treating investigator
  26. * Participants with a 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 by the treating investigator
  27. * Participants with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to randomization
  28. * Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  29. * Participants must not have an active autoimmune disease that has required systemic treatment within 730 days prior to randomization (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) is not considered a form of systemic treatment and is allowed
  30. * Participants must not have any history of primary immunodeficiency
  31. * Participants must be able to safely receive study therapy and must not have experienced the following:
  32. * Any grade 3 or worse immune-mediated adverse event. Exception: asymptomatic nonbullous/nonexfoliative rash
  33. * Any unresolved grade 2 immune-mediated adverse event
  34. * Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
  35. * Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
  36. * Participants must not have any history of organ transplant that requires use of immunosuppressives
  37. * Participants must not have received a live or live attenuated vaccine within 28 days prior to 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 COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated and are not allowed
  38. * Participants must not have clinical signs or symptoms of active tuberculosis infection
  39. * Participants must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
  40. * Participants must not have had a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
  41. * Participants must not have a history of gastrointestinal perforation or fistula within 6 months prior to randomization
  42. * Participants must not have grade 3-4 gastrointestinal bleeding (defined by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]5) within 3 months prior to randomization. No history of gastrointestinal (GI) bleed within 3 months prior to randomization
  43. * 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 6 months prior to randomization, or serious uncontrolled cardiac arrhythmia
  44. * Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization
  45. * Participants must not have gross hemoptysis within two months prior to randomization (defined as bright red blood or ≥ 1/2 teaspoon) or with radiographic evidence of intratumor cavitation or has radiologically documented evidence of major blood vessel invasion or encasement by cancer
  46. * Participants must not have been diagnosed with venous thrombosis within 3 months prior to randomization. Participants with venous thrombosis diagnosed more than 3 months prior to randomization must be on stable doses of anticoagulants
  47. * Participants must not have cirrhosis at a level of Child-Pugh B (or worse) AND a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis, OR any degree of cirrhosis
  48. * Participants must not be pregnant or breastfeeding (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 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
  49. * Participants must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
  50. * Participants must be offered participation in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG specimen tracking system
  51. * 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
  52. * 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. NOTE: 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
  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

Jennifer Beeler
CONTACT
210-614-8808
jbeeler@swog.org
SWOG Network Operations Center
CONTACT
protocols@swog.org

Principal Investigator

Saiama N Waqar
PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network

Study Locations (Sites)

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
UPMC Western Maryland
Cumberland, Maryland, 21502
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
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
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
United States
Billings Clinic Cancer Center
Billings, Montana, 59101
United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560
United States
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, 15009
United States
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001
United States
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania, 16066
United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121
United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
United States
IRMC Cancer Center
Indiana, Pennsylvania, 15701
United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, 15901
United States
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132
United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
United States
UPMC Hillman Cancer Center in Coraopolis
Moon, Pennsylvania, 15108
United States
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania, 15666
United States
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania, 15642
United States
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, 15065
United States
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105
United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237
United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346
United States
UPMC Cancer Center-Washington
Washington, Pennsylvania, 15301
United States
UPMC Susquehanna
Williamsport, Pennsylvania, 17701
United States
Divine Providence Hospital
Williamsport, Pennsylvania, 17754
United States
Saint Joseph's/Candler - Bluffton Campus
Bluffton, South Carolina, 29910
United States
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827
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
West Virginia University Healthcare
Morgantown, West Virginia, 26506
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
United States
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081
United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
United States

Collaborators and Investigators

Sponsor: SWOG Cancer Research Network

  • Saiama N Waqar, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

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 Date2025-07-11
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-07-11
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8