RECRUITING

Study of Novel Treatment Combinations in Patients With 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

The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC. The primary objectives of this study are: Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.

Official Title

A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)

Quick Facts

Study Start:2023-03-16
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05633667

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 documented non-small-cell lung cancer (NSCLC).
  2. * No known actionable genomic alterations for which targeted therapies are available.
  3. * Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
  4. * Measurable disease per response evaluation criteria in solid tumors.
  5. * Adequate hematologic and end-organ function.
  6. * Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.
  7. * Stage IV NSCLC.
  8. * For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
  9. * PD-L1 status by central confirmation.
  10. * No prior systemic treatment for metastatic NSCLC.
  11. * Stage IV NSCLC.
  12. * In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have received treatment with at least 1 targeted therapy to the appropriate genomic alteration.
  13. * Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T\[3-4\]N2) NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8).
  14. * Planned surgery must comprise of lobectomy, sleeve lobectomy, or bi-lobectomy.
  15. * PD-L1 status by central confirmation.
  16. * For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
  1. * Mixed small-cell lung cancer and NSCLC histology.
  2. * Active second malignancy.
  3. * Active autoimmune disease.
  4. * History of or current non-infectious pneumonitis/interstitial lung disease.
  5. * Active serious infection within 4 weeks prior to study treatment.
  6. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  7. * Received previous anticancer therapy within 4 weeks prior to enrollment.
  8. * NSCLC previously treated with systemic therapy or radiotherapy.
  9. * Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs).

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center
CONTACT
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Arizona Oncology Associates,Substudy-01
Tucson, Arizona, 85711
United States
Arizona Oncology Associates,Substudy-02
Tucson, Arizona, 85711
United States
Rocky Mountain Cancer Center,Substudy-01
Denver, Colorado, 80218
United States
Rocky Mountain Cancer Center,Substudy-02
Denver, Colorado, 80218
United States
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
Fort Wayne, Indiana, 46845
United States
Washington University School of Medicine - Siteman Cancer Center,Substudy-01
Saint Louis, Missouri, 63110
United States
Washington University School of Medicine - Siteman Cancer Center,Substudy-02
Saint Louis, Missouri, 63110
United States
Washington University School of Medicine - Siteman Cancer Center,Substudy-03
Saint Louis, Missouri, 63110
United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri, 63110
United States
Oncology Hematology Care Clinical Trials, LLC,Substudy-01
Cincinnati, Ohio, 45242
United States
Oncology Hematology Care Clinical Trials, LLC,Substudy-02
Cincinnati, Ohio, 45242
United States
Oncology Associates of Oregon, PC,Substudy-01
Eugene, Oregon, 97401
United States
Oncology Associates of Oregon, PC,Substudy-02
Eugene, Oregon, 97401
United States
Texas Oncology - Central South,Substudy-01
Austin, Texas, 78745
United States
Texas Oncology - Central South,Substudy-02
Austin, Texas, 78745
United States
US Oncology Investigational Products Center (IPC),Substudy-01
Fairfax, Virginia, 22031
United States
US Oncology Investigational Products Center (IPC),Substudy-02
Fairfax, Virginia, 22031
United States
Fred Hutchinson Cancer Center,Substudy-01
Seattle, Washington, 98109
United States
Fred Hutchinson Cancer Center,Substudy-02
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

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 Date2023-03-16
Study Completion Date2027-01

Study Record Updates

Study Start Date2023-03-16
Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Cancer
  • Advanced or Metastatic Non-Small-Cell Lung Cancer
  • Resectable Non-Small-Cell Lung Cancer