Study of Novel Treatment Combinations in Patients With Lung 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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Study of Novel Treatment Combinations in Patients With Lung Cancer

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Tucson

Arizona Oncology Associates,Substudy-01, Tucson, Arizona, United States, 85711

Tucson

Arizona Oncology Associates,Substudy-02, Tucson, Arizona, United States, 85711

Denver

Rocky Mountain Cancer Center,Substudy-01, Denver, Colorado, United States, 80218

Denver

Rocky Mountain Cancer Center,Substudy-02, Denver, Colorado, United States, 80218

Fort Wayne

Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03, Fort Wayne, Indiana, United States, 46845

Saint Louis

Washington University School of Medicine - Siteman Cancer Center,Substudy-01, Saint Louis, Missouri, United States, 63110

Saint Louis

Washington University School of Medicine - Siteman Cancer Center,Substudy-02, Saint Louis, Missouri, United States, 63110

Saint Louis

Washington University School of Medicine - Siteman Cancer Center,Substudy-03, Saint Louis, Missouri, United States, 63110

Saint Louis

Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States, 63110

Cincinnati

Oncology Hematology Care Clinical Trials, LLC,Substudy-01, Cincinnati, Ohio, United States, 45242

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2027-01