OVERVIEW
A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung) (VELOCITY-Lung)
PROTOCOL SUMMARY
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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Lung Cancer, Advanced or Metastatic Non-Small-Cell Lung Cancer, Resectable Non-Small-Cell Lung Cancer
Gender
N/A
Date
March 2023 - September 2029
Study Type
Interventional
Study Phase
Phase 2
Product
Zimberelimab (ZIM), Domvanalimab (DOM), Sacituzumab govitecan-hziy (SG), Etrumadenant (ETRUMA), Carboplatin, Cisplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel, Docetaxel, Nivolumab
Eligibility information
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.
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
Locations
Locations (89)
Arizona Oncology Associates,Substudy-02
Tucson, Arizona, United States, 85711
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
Fort Wayne, Indiana, United States, 46845
Baptist Health Lexington,Substudy-03
Lexington, Kentucky, United States, 40503
Washington University School of Medicine - Siteman Cancer Center,Substudy-01
St Louis, Missouri, United States, 63110
Washington University School of Medicine - Siteman Cancer Center,Substudy-02
St Louis, Missouri, United States, 63110
Washington University School of Medicine - Siteman Cancer Center,Substudy-03
St Louis, Missouri, United States, 63110
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Oncology Hematology Care Clinical Trials, LLC,Substudy-01
Cincinnati, Ohio, United States, 45242
Oncology Hematology Care Clinical Trials, LLC,Substudy-02
Cincinnati, Ohio, United States, 45242
Oncology Associates of Oregon, PC,Substudy-01
Eugene, Oregon, United States, 97401
Oncology Associates of Oregon, PC,Substudy-02
Eugene, Oregon, United States, 97401
Fundação Pio XII - Hospital de Amor,Substudy-01
Barretos, Brazil, 14784-400
Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03
Porto Alegre, Brazil, 90110-270
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01
Porto Alegre, Brazil, 90610001
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03
Porto Alegre, Brazil, 90610001
BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01
São Paulo, Brazil, 1509
Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01
São Paulo, Brazil, 1509
Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03
São Paulo, Brazil, 1509
Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03
São Paulo, Brazil, 1509
Hadassah University Medical Center,Substudy-03
Jerusalem, Israel, 91120
Chungbuk National University Hospital,Substudy-01
Cheongju-si, South Korea, 28644
Chungbuk National University Hospital,Substudy-02
Cheongju-si, South Korea, 28644
Chonnam National University Hwasun Hospital,Substudy-01
Gwangju, South Korea, 61469
Chonnam National University Hwasun Hospital,Substudy-03
Gwangju, South Korea, 61469
Seoul National University Bundang Hospital,Substudy-01
Gyeonggi-do, South Korea, 463-707
Seoul National University Bundang Hospital,Substudy-03
Gyeonggi-do, South Korea, 463-707
Kosin University Gospel Hospital,Substudy-01
Seogu, South Korea, 49267
Kosin University Gospel Hospital,Substudy-03
Seogu, South Korea, 49267
Severance Hospital, Yonsei University Health System,Substudy-03
Seoul, South Korea, 03722
Severance Hospital, Yonsei University Health System,Substudy-01
Seoul, South Korea, 120-752
Severance Hospital, Yonsei University Health System,Substudy-02
Seoul, South Korea, 120-752
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
Kaohsiung City, Taiwan, 80756
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
Kaohsiung City, Taiwan, 80756
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
Kaohsiung City, Taiwan, 80756
Kaohsiung Chang Gung Memorial Hospital,Substudy-01
Kaohsiung City, Taiwan, 83301
Kaohsiung Chang Gung Memorial Hospital,Substudy-02
Kaohsiung City, Taiwan, 83301
Kaohsiung Chang Gung Memorial Hospital,Substudy-03
Kaohsiung City, Taiwan, 83301
Adana City Training and Research Hospital,Substudy-01
Adana, Turkey (Türkiye), 01120
Memorial Ankara Hastanesi,Substudy-01
Ankara, Turkey (Türkiye), 06520
Dicle University Medical Faculty,Substudy-03
Diyarbakır, Turkey (Türkiye), 21280
Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01
Konya, Turkey (Türkiye), 42080
Necmettin Erbakan Universitesi,Substudy-03
Meram Konya, Turkey (Türkiye), 42080
Gazi University Medical Faculty,Substudy-01
Yenimahalle, Turkey (Türkiye),
Gazi University Medical Faculty,Substudy-03
Yenimahalle, Turkey (Türkiye),
Birmingham Heartlands Hospital,Substudy-03
Birmingham, United Kingdom, B9 5SS
University Hospitals Birmingham NHS Trust,Substudy-01
Birmingham, United Kingdom, B9 5SS
University Hospitals Birmingham NHS Trust,Substudy-02
Birmingham, United Kingdom, B9 5SS
St James University Hospital,,Substudy-01
Leeds, United Kingdom, LS9 7TF
St. Bartholomew's Hospital,Substudy-01
London, United Kingdom, E1 1BB
St. Bartholomew's Hospital,Substudy-02
London, United Kingdom, E1 1BB
St. Bartholomew's Hospital,Substudy-03
London, United Kingdom, E1 1BB
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