Lung Cancer Clinical Trial
— VELOCITY-LungOfficial title:
A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)
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 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.
| Status | Recruiting |
| Enrollment | 397 |
| Est. completion date | January 2027 |
| Est. primary completion date | January 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: All Substudies: - 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. Substudy 01: All Experimental arms - 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. Substudy 02: All Experimental arms - 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. Substudy 03: All Experimental arms - 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. Key Exclusion Criteria: All Substudies: - 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. Substudy 01 and 02 - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Received previous anticancer therapy within 4 weeks prior to enrollment. Substudy 03: All Experimental arms - NSCLC previously treated with systemic therapy or radiotherapy. - Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs). Note: Other protocol defined inclusion/exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Queen Elizabeth Hospital,Substudy-01 | Hong Kong | |
| Hong Kong | Queen Elizabeth Hospital,Substudy-02 | Hong Kong | |
| Hong Kong | Queen Mary Hospital,Substudy-01 | Hong Kong | |
| Hong Kong | Queen Mary Hospital,Substudy-02 | Hong Kong | |
| Hong Kong | Prince of Wales Hospital,Substudy-02 | New Territories | |
| Israel | Rambam Health Care Campus,Substudy-01 | Haifa | |
| Israel | Rambam Health Care Campus,Substudy-02 | Haifa | |
| Israel | Rambam Health Care Campus,Substudy-03 | Haifa | |
| Israel | Hadassah University Medical Center,Substudy-03 | Jerusalem | |
| Israel | Shaare Zedek Medical Center,Substudy-01 | Jerusalem | |
| Israel | Shaare Zedek Medical Center,Substudy-02 | Jerusalem | |
| Israel | Shaare Zedek Medical Center,Substudy-03 | Jerusalem | |
| Israel | Rabin Medical Center,Substudy-03 | Petah Tiqva | |
| Israel | Tel Aviv Sourasky Medical Center,Substudy-01 | Tel Aviv-Yafo | |
| Israel | Tel Aviv Sourasky Medical Center,Substudy-02 | Tel Aviv-Yafo | |
| Israel | Tel-Aviv Sourasky Medical Center,Substudy-03 | Tel Aviv-Yafo | |
| Korea, Republic of | Chungbuk National University Hospital,Substudy-01 | Cheongju-si | |
| Korea, Republic of | Chungbuk National University Hospital,Substudy-02 | Cheongju-si | |
| Korea, Republic of | National Cancer Center,Substudy-01 | Goyang | |
| Korea, Republic of | National Cancer Center,Substudy-02 | Goyang | |
| Korea, Republic of | National Cancer Center,Substudy-03 | Goyang | |
| Korea, Republic of | Chonnam National University Hwasun Hospital,Substudy-03 | Gwangju | |
| Korea, Republic of | Seoul National University Bundang Hospital,Substudy-03 | Gyeonggi-do | |
| Korea, Republic of | Kosin University Gospel Hospital,Substudy-03 | Seo-gu | |
| Korea, Republic of | Asan Medical Center,Substudy-02 | Seoul | |
| Korea, Republic of | Asan Medical Center,Substudy-03 | Seoul | |
| Korea, Republic of | Asan Medical Centre,Substudy-01 | Seoul | |
| Korea, Republic of | Korea University Guro Hospital,Substudy-03 | Seoul | |
| Korea, Republic of | Samsung Medical Center,Substudy-01 | Seoul | |
| Korea, Republic of | Samsung Medical Center,Substudy-02 | Seoul | |
| Korea, Republic of | Seoul National University,Substudy-01 | Seoul | |
| Korea, Republic of | Seoul National University,Substudy-02 | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System,Substudy-01 | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System,Substudy-02 | Seoul | |
| Taiwan | Changhua Christian Hospital,Substudy-01 | Changhua City | |
| Taiwan | Changhua Christian Hospital,Substudy-02 | Changhua City | |
| Taiwan | Changhua Christian Hospital,Substudy-03 | Changhua City | |
| Taiwan | Kaohsiung Chang Gung Memorial Hospital,Substudy-01 | Kaohsiung | |
| Taiwan | Kaohsiung Chang Gung Memorial Hospital,Substudy-02 | Kaohsiung | |
| Taiwan | Kaohsiung Chang Gung Memorial Hospital,Substudy-03 | Kaohsiung | |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01 | Kaohsiung City | |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02 | Kaohsiung City | |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03 | Kaohsiung City | |
| Taiwan | National Taiwan University Hospital,Substudy-01 | Taipei City | |
| Taiwan | National Taiwan University Hospital,Substudy-02 | Taipei City | |
| United Kingdom | University Hospitals Birmingham NHS Trust,Substudy-01 | Birmingham | |
| United Kingdom | University Hospitals Birmingham NHS Trust,Substudy-02 | Birmingham | |
| United Kingdom | St James University Hospital,,Substudy-01 | Leeds | |
| United Kingdom | St. Bartholomew's Hospital,Substudy-01 | London | |
| United Kingdom | St. Bartholomew's Hospital,Substudy-02 | London | |
| United States | Texas Oncology - Central South,Substudy-01 | Austin | Texas |
| United States | Texas Oncology - Central South,Substudy-02 | Austin | Texas |
| United States | Oncology Hematology Care Clinical Trials, LLC,Substudy-01 | Cincinnati | Ohio |
| United States | Oncology Hematology Care Clinical Trials, LLC,Substudy-02 | Cincinnati | Ohio |
| United States | Rocky Mountain Cancer Center,Substudy-01 | Denver | Colorado |
| United States | Rocky Mountain Cancer Center,Substudy-02 | Denver | Colorado |
| United States | Oncology Associates of Oregon, PC,Substudy-01 | Eugene | Oregon |
| United States | Oncology Associates of Oregon, PC,Substudy-02 | Eugene | Oregon |
| United States | US Oncology Investigational Products Center (IPC),Substudy-01 | Fairfax | Virginia |
| United States | US Oncology Investigational Products Center (IPC),Substudy-02 | Fairfax | Virginia |
| United States | Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03 | Fort Wayne | Indiana |
| United States | Washington University School of Medicine - Siteman Cancer Center | Saint Louis | Missouri |
| United States | Washington University School of Medicine - Siteman Cancer Center,Substudy-01 | Saint Louis | Missouri |
| United States | Washington University School of Medicine - Siteman Cancer Center,Substudy-02 | Saint Louis | Missouri |
| United States | Fred Hutchinson Cancer Center,Substudy-01 | Seattle | Washington |
| United States | Fred Hutchinson Cancer Center,Substudy-02 | Seattle | Washington |
| United States | Arizona Oncology Associates,Substudy-01 | Tucson | Arizona |
| United States | Arizona Oncology Associates,Substudy-02 | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences | Arcus Biosciences, Inc. |
United States, Hong Kong, Israel, Korea, Republic of, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response. | Up to 5 years | |
| Primary | Substudy 03: Complete Pathological Response (pCR) Rate | pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review. | Up to 5 years | |
| Secondary | Substudies 01 and 02: Progression-free Survival (PFS) According to RECIST Version 1.1 | PFS is defined as the time from the date of randomization until disease progression (PD) or death, whichever comes first. | Up to 5 years | |
| Secondary | Substudies 01 and 02: Duration of response (DOR) According to RECIST Version 1.1 | DOR is defined as the time from the first response (CR or PR) until the first documented PD, or death, whichever comes first. | Up to 5 years | |
| Secondary | All Substudies: Overall survival (OS) | OS is defined as the time from the date of randomization until death from any cause. | Up to 5 years | |
| Secondary | Substudy 03: Event-Free Survival (EFS) | Event-Free Survival (EFS) is defined as the time from randomization until any of the following events: any progression precluding surgery or preventing completion of surgery, progression or recurrence of disease after surgery (local or distant), as assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death due to any cause, whichever occurs first. Participants who do not undergo surgery for reasons other than progression will be considered to have had an event at progression or at death. | Up to 5 years | |
| Secondary | Substudy 03: Major Pathological Response (MPR) Rate | MPR rate is defined as the percentage of participants with = 10% residual tumor in lung and lymph nodes at surgery as evaluated by local pathology review. | Up to 5 years | |
| Secondary | All Substudies: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs | First dose date up to 24 months plus 100 days | ||
| Secondary | All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities | First dose date up to 24 months plus 100 days |
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