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NCT05633667Active, not recruitingPhase 2

Study of Novel Treatment Combinations in Patients With Lung Cancer

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

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
192 (actual)
First submitted
21 Nov 2022
Start date
16 Mar 2023
Primary completion date
Sept 2029
Lead sponsor
Gilead Sciences
Diseases
Lung cancer
NCT number
NCT05633667

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 192
  • From 16 Mar 2023 to the primary completion date, Sept 2029
  • 89 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active serious infection within 4 weeks prior to study treatment.
    • Substudy 01 and 02
  • 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

Other illness

  • Mixed small-cell lung cancer and NSCLC histology.
  • Active second malignancy.
  • Active autoimmune disease.
  • History of or current non-infectious pneumonitis/interstitial lung disease.

Other

  • All Substudies:
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (89)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundação Pio XII - Hospital de Amor,Substudy-01
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BarretosBrazilUnknown status
Hospital Mae de Deus
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Porto AlegreBrazilUnknown status
Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03
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Porto AlegreBrazilUnknown status
Hospital Mae de Deus,Substudy-01
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Porto AlegreBrazilUnknown status
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03
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Porto AlegreBrazilUnknown status
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01
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Porto AlegreBrazilUnknown status
BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01
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São PauloBrazilUnknown status
Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01
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São PauloBrazilUnknown status
Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03
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São PauloBrazilUnknown status
Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03
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São PauloBrazilUnknown status
University Hospitals Birmingham NHS Trust,Substudy-01
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BirminghamUnited KingdomUnknown status
Birmingham Heartlands Hospital,Substudy-03
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BirminghamUnited KingdomUnknown status
University Hospitals Birmingham NHS Trust,Substudy-02
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BirminghamUnited KingdomUnknown status
St James University Hospital,,Substudy-01
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LeedsUnited KingdomUnknown status
St. Bartholomew's Hospital,Substudy-02
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LondonUnited KingdomUnknown status
St. Bartholomew's Hospital,Substudy-01
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LondonUnited KingdomUnknown status
St. Bartholomew's Hospital,Substudy-03
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LondonUnited KingdomUnknown status
Queen Elizabeth Hospital,Substudy-02
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Hong KongHong Kong SAR ChinaUnknown status
Queen Elizabeth Hospital,Substudy-01
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Hong KongHong Kong SAR ChinaUnknown status
Queen Mary Hospital,Substudy-02
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Hong KongHong Kong SAR ChinaUnknown status
Queen Mary Hospital,Substudy-01
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hospital,Substudy-01
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New TerritoriesHong Kong SAR ChinaUnknown status
Prince of Wales Hospital,Substudy-02
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New TerritoriesHong Kong SAR ChinaUnknown status
Rambam Health Care Campus,Substudy-01
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HaifaIsraelUnknown status
Rambam Health Care Campus,Substudy-02
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HaifaIsraelUnknown status
Rambam Health Care Campus,Substudy-03
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HaifaIsraelUnknown status
Hadassah Medical Center,Substudy-01
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JerusalemIsraelUnknown status
Hadassah University Medical Center,Substudy-03
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JerusalemIsraelUnknown status
Shaare Zedek Medical Center,Substudy-02
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JerusalemIsraelUnknown status
Shaare Zedek Medical Center,Substudy-01
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JerusalemIsraelUnknown status
Shaare Zedek Medical Center,Substudy-03
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JerusalemIsraelUnknown status
Tel-Aviv Sourasky Medical Center,Substudy-03
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Tel AvivIsraelUnknown status
Tel Aviv Sourasky Medical Center,Substudy-02
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Tel AvivIsraelUnknown status
Tel Aviv Sourasky Medical Center,Substudy-01
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Tel AvivIsraelUnknown status
Chungbuk National University Hospital,Substudy-02
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Cheongju-siSouth KoreaUnknown status
Chungbuk National University Hospital,Substudy-01
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Cheongju-siSouth KoreaUnknown status
National Cancer Center,Substudy-02
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GoyangSouth KoreaUnknown status
National Cancer Center,Substudy-01
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GoyangSouth KoreaUnknown status
National Cancer Center,Substudy-03
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GoyangSouth KoreaUnknown status
Chonnam National University Hwasun Hospital,Substudy-01
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GwangjuSouth KoreaUnknown status
Chonnam National University Hwasun Hospital,Substudy-03
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GwangjuSouth KoreaUnknown status
Seoul National University Bundang Hospital,Substudy-01
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Gyeonggi-doSouth KoreaUnknown status
Seoul National University Bundang Hospital,Substudy-03
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Gyeonggi-doSouth KoreaUnknown status
Kosin University Gospel Hospital,Substudy-01
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SeoguSouth KoreaUnknown status
Kosin University Gospel Hospital,Substudy-03
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SeoguSouth KoreaUnknown status
Seoul National University,Substudy-02
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SeoulSouth KoreaUnknown status
Samsung Medical Center,Substudy-02
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SeoulSouth KoreaUnknown status
Asan Medical Center,Substudy-03
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SeoulSouth KoreaUnknown status
Samsung Medical Center,Substudy-01
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SeoulSouth KoreaUnknown status
Samsung Medical Center,Substudy-03
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SeoulSouth KoreaUnknown status
Asan Medical Center,Substudy-02
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System,Substudy-03
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System,Substudy-02
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SeoulSouth KoreaUnknown status
Korea University Guro Hospital,Substudy-03
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System,Substudy-01
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SeoulSouth KoreaUnknown status
Korea University Guro Hospital,Substudy-01
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SeoulSouth KoreaUnknown status
Asan Medical Centre,Substudy-01
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SeoulSouth KoreaUnknown status
Changhua Christian Hospital,Substudy-02
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ChanghuaTaiwanUnknown status
Changhua Christian Hospital,Substudy-03
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ChanghuaTaiwanUnknown status
Changhua Christian Hospital,Substudy-01
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ChanghuaTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Chang Gung Memorial Hospital,Substudy-01
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Chang Gung Memorial Hospital,Substudy-03
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Chang Gung Memorial Hospital,Substudy-02
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
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Kaohsiung CityTaiwanUnknown status
National Taiwan University Hospital,Substudy-01
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TaipeiTaiwanUnknown status
National Taiwan University Hospital,Substudy-02
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TaipeiTaiwanUnknown status
Oncology Hematology Care Clinical Trials, LLC,Substudy-02
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CincinnatiUnited StatesUnknown status
Oncology Hematology Care Clinical Trials, LLC,Substudy-01
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CincinnatiUnited StatesUnknown status
Oncology Associates of Oregon, PC,Substudy-01
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EugeneUnited StatesUnknown status
Oncology Associates of Oregon, PC,Substudy-02
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EugeneUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
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Fort WayneUnited StatesUnknown status
Baptist Health Lexington,Substudy-03
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LexingtonUnited StatesUnknown status
Washington University School of Medicine - Siteman Cancer Center,Substudy-02
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St LouisUnited StatesUnknown status
Washington University School of Medicine - Siteman Cancer Center
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St LouisUnited StatesUnknown status
Washington University School of Medicine - Siteman Cancer Center,Substudy-01
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St LouisUnited StatesUnknown status
Washington University School of Medicine - Siteman Cancer Center,Substudy-03
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St LouisUnited StatesUnknown status
Arizona Oncology Associates,Substudy-02
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TucsonUnited StatesUnknown status
Adana City Training and Research Hospital,Substudy-01
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AdanaTurkey (Türkiye)Unknown status
Memorial Ankara Hastanesi,Substudy-01
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AnkaraTurkey (Türkiye)Unknown status
Memorial Ankara Hospital,Substudy-03
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AnkaraTurkey (Türkiye)Unknown status
Medical Park Samsun,Substudy-01
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AtakumTurkey (Türkiye)Unknown status
Dicle University,Substudy-01
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DiyarbakırTurkey (Türkiye)Unknown status
Dicle University Medical Faculty,Substudy-03
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DiyarbakırTurkey (Türkiye)Unknown status
Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01
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KonyaTurkey (Türkiye)Unknown status
Necmettin Erbakan Universitesi,Substudy-03
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Meram KonyaTurkey (Türkiye)Unknown status
Gazi University Medical Faculty,Substudy-01
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YenimahalleTurkey (Türkiye)Unknown status
Gazi University Medical Faculty,Substudy-03
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YenimahalleTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.