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
Sites (89)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundação Pio XII - Hospital de Amor,Substudy-01 Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Hospital Mae de Deus Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Mae de Deus,Substudy-01 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01 Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03 Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| University Hospitals Birmingham NHS Trust,Substudy-01 Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Birmingham Heartlands Hospital,Substudy-03 Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| University Hospitals Birmingham NHS Trust,Substudy-02 Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| St James University Hospital,,Substudy-01 Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| St. Bartholomew's Hospital,Substudy-02 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. Bartholomew's Hospital,Substudy-01 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. Bartholomew's Hospital,Substudy-03 Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Queen Elizabeth Hospital,Substudy-02 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Elizabeth Hospital,Substudy-01 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Mary Hospital,Substudy-02 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Mary Hospital,Substudy-01 Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Prince of Wales Hospital,Substudy-01 Coordinator of this site? Confirm its status | New Territories | Hong Kong SAR China | Unknown status |
| Prince of Wales Hospital,Substudy-02 Coordinator of this site? Confirm its status | New Territories | Hong Kong SAR China | Unknown status |
| Rambam Health Care Campus,Substudy-01 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Care Campus,Substudy-02 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Care Campus,Substudy-03 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center,Substudy-01 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Hadassah University Medical Center,Substudy-03 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Shaare Zedek Medical Center,Substudy-02 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Shaare Zedek Medical Center,Substudy-01 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Shaare Zedek Medical Center,Substudy-03 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center,Substudy-03 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center,Substudy-02 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center,Substudy-01 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Chungbuk National University Hospital,Substudy-02 Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Chungbuk National University Hospital,Substudy-01 Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| National Cancer Center,Substudy-02 Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| National Cancer Center,Substudy-01 Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| National Cancer Center,Substudy-03 Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital,Substudy-01 Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital,Substudy-03 Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
| Seoul National University Bundang Hospital,Substudy-01 Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Seoul National University Bundang Hospital,Substudy-03 Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Kosin University Gospel Hospital,Substudy-01 Coordinator of this site? Confirm its status | Seogu | South Korea | Unknown status |
| Kosin University Gospel Hospital,Substudy-03 Coordinator of this site? Confirm its status | Seogu | South Korea | Unknown status |
| Seoul National University,Substudy-02 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center,Substudy-02 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center,Substudy-03 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center,Substudy-01 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center,Substudy-03 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center,Substudy-02 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System,Substudy-03 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System,Substudy-02 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital,Substudy-03 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System,Substudy-01 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital,Substudy-01 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Centre,Substudy-01 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Changhua Christian Hospital,Substudy-02 Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Changhua Christian Hospital,Substudy-03 Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Changhua Christian Hospital,Substudy-01 Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital,Substudy-01 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital,Substudy-03 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital,Substudy-02 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Taiwan University Hospital,Substudy-01 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital,Substudy-02 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Oncology Hematology Care Clinical Trials, LLC,Substudy-02 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Oncology Hematology Care Clinical Trials, LLC,Substudy-01 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Oncology Associates of Oregon, PC,Substudy-01 Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Oncology Associates of Oregon, PC,Substudy-02 Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03 Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Baptist Health Lexington,Substudy-03 Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Washington University School of Medicine - Siteman Cancer Center,Substudy-02 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine - Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine - Siteman Cancer Center,Substudy-01 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine - Siteman Cancer Center,Substudy-03 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Arizona Oncology Associates,Substudy-02 Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Adana City Training and Research Hospital,Substudy-01 Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Memorial Ankara Hastanesi,Substudy-01 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Memorial Ankara Hospital,Substudy-03 Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Medical Park Samsun,Substudy-01 Coordinator of this site? Confirm its status | Atakum | Turkey (Türkiye) | Unknown status |
| Dicle University,Substudy-01 Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Unknown status |
| Dicle University Medical Faculty,Substudy-03 Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Unknown status |
| Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01 Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Unknown status |
| Necmettin Erbakan Universitesi,Substudy-03 Coordinator of this site? Confirm its status | Meram Konya | Turkey (Türkiye) | Unknown status |
| Gazi University Medical Faculty,Substudy-01 Coordinator of this site? Confirm its status | Yenimahalle | Turkey (Türkiye) | Unknown status |
| Gazi University Medical Faculty,Substudy-03 Coordinator of this site? Confirm its status | Yenimahalle | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.