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

Status: Recruiting
Location: See all (95) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Arizona
Arizona Oncology Associates,Substudy-01
WITHDRAWN
Tucson
Arizona Oncology Associates,Substudy-02
COMPLETED
Tucson
Colorado
Rocky Mountain Cancer Center,Substudy-01
WITHDRAWN
Denver
Rocky Mountain Cancer Center,Substudy-02
WITHDRAWN
Denver
Indiana
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
RECRUITING
Fort Wayne
Kentucky
Baptist Health Lexington,Substudy-03
RECRUITING
Lexington
Missouri
Washington University School of Medicine - Siteman Cancer Center
RECRUITING
St Louis
Washington University School of Medicine - Siteman Cancer Center,Substudy-01
RECRUITING
St Louis
Washington University School of Medicine - Siteman Cancer Center,Substudy-02
ACTIVE_NOT_RECRUITING
St Louis
Washington University School of Medicine - Siteman Cancer Center,Substudy-03
RECRUITING
St Louis
Ohio
Oncology Hematology Care Clinical Trials, LLC,Substudy-01
ACTIVE_NOT_RECRUITING
Cincinnati
Oncology Hematology Care Clinical Trials, LLC,Substudy-02
ACTIVE_NOT_RECRUITING
Cincinnati
Oregon
Oncology Associates of Oregon, PC,Substudy-01
ACTIVE_NOT_RECRUITING
Eugene
Oncology Associates of Oregon, PC,Substudy-02
ACTIVE_NOT_RECRUITING
Eugene
Texas
Texas Oncology - Central South,Substudy-01
WITHDRAWN
Austin
Texas Oncology - Central South,Substudy-02
WITHDRAWN
Austin
Virginia
US Oncology Investigational Products Center (IPC),Substudy-01
WITHDRAWN
Fairfax
US Oncology Investigational Products Center (IPC),Substudy-02
WITHDRAWN
Fairfax
Washington
Fred Hutchinson Cancer Center,Substudy-01
WITHDRAWN
Seattle
Fred Hutchinson Cancer Center,Substudy-02
WITHDRAWN
Seattle
Other Locations
Brazil
Fundação Pio XII - Hospital de Amor,Substudy-01
RECRUITING
Barretos
Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03
RECRUITING
Porto Alegre
Hospital Mae de Deus
RECRUITING
Porto Alegre
Hospital Mae de Deus,Substudy-01
RECRUITING
Porto Alegre
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03
RECRUITING
Porto Alegre
BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01
RECRUITING
São Paulo
Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03
RECRUITING
São Paulo
Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03
RECRUITING
São Paulo
Hong Kong Special Administrative Region
Queen Elizabeth Hospital,Substudy-01
RECRUITING
Hong Kong
Queen Elizabeth Hospital,Substudy-02
ACTIVE_NOT_RECRUITING
Hong Kong
Queen Mary Hospital,Substudy-01
RECRUITING
Hong Kong
Queen Mary Hospital,Substudy-02
ACTIVE_NOT_RECRUITING
Hong Kong
Prince of Wales Hospital,Substudy-01
RECRUITING
New Territories
Prince of Wales Hospital,Substudy-02
ACTIVE_NOT_RECRUITING
New Territories
Israel
Rambam Health Care Campus,Substudy-01
RECRUITING
Haifa
Rambam Health Care Campus,Substudy-02
ACTIVE_NOT_RECRUITING
Haifa
Rambam Health Care Campus,Substudy-03
RECRUITING
Haifa
Hadassah Medical Center,Substudy-01
RECRUITING
Jerusalem
Hadassah University Medical Center,Substudy-03
RECRUITING
Jerusalem
Shaare Zedek Medical Center,Substudy-01
RECRUITING
Jerusalem
Shaare Zedek Medical Center,Substudy-02
ACTIVE_NOT_RECRUITING
Jerusalem
Shaare Zedek Medical Center,Substudy-03
RECRUITING
Jerusalem
Rabin Medical Center,Substudy-03
WITHDRAWN
Petah Tikva
Tel Aviv Sourasky Medical Center,Substudy-01
RECRUITING
Tel Aviv
Tel Aviv Sourasky Medical Center,Substudy-02
ACTIVE_NOT_RECRUITING
Tel Aviv
Tel-Aviv Sourasky Medical Center,Substudy-03
RECRUITING
Tel Aviv
Republic of Korea
Chungbuk National University Hospital,Substudy-01
RECRUITING
Cheongju-si
Chungbuk National University Hospital,Substudy-02
ACTIVE_NOT_RECRUITING
Cheongju-si
National Cancer Center,Substudy-01
RECRUITING
Goyang
National Cancer Center,Substudy-02
ACTIVE_NOT_RECRUITING
Goyang
National Cancer Center,Substudy-03
RECRUITING
Goyang
Chonnam National University Hwasun Hospital,Substudy-01
RECRUITING
Gwangju
Chonnam National University Hwasun Hospital,Substudy-03
RECRUITING
Gwangju
Seoul National University Bundang Hospital,Substudy-01
RECRUITING
Gyeonggi-do
Seoul National University Bundang Hospital,Substudy-03
RECRUITING
Gyeonggi-do
Kosin University Gospel Hospital,Substudy-01
RECRUITING
Seogu
Kosin University Gospel Hospital,Substudy-03
RECRUITING
Seogu
Asan Medical Center,Substudy-02
ACTIVE_NOT_RECRUITING
Seoul
Asan Medical Center,Substudy-03
RECRUITING
Seoul
Asan Medical Centre,Substudy-01
RECRUITING
Seoul
Korea University Guro Hospital,Substudy-01
RECRUITING
Seoul
Korea University Guro Hospital,Substudy-03
RECRUITING
Seoul
Samsung Medical Center,Substudy-01
RECRUITING
Seoul
Samsung Medical Center,Substudy-02
ACTIVE_NOT_RECRUITING
Seoul
Samsung Medical Center,Substudy-03
RECRUITING
Seoul
Seoul National University,Substudy-01
WITHDRAWN
Seoul
Seoul National University,Substudy-02
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System,Substudy-01
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System,Substudy-02
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System,Substudy-03
RECRUITING
Seoul
Taiwan
Changhua Christian Hospital,Substudy-01
RECRUITING
Changhua
Changhua Christian Hospital,Substudy-02
ACTIVE_NOT_RECRUITING
Changhua
Changhua Christian Hospital,Substudy-03
RECRUITING
Changhua
Kaohsiung Chang Gung Memorial Hospital,Substudy-01
RECRUITING
Kaohsiung City
Kaohsiung Chang Gung Memorial Hospital,Substudy-02
ACTIVE_NOT_RECRUITING
Kaohsiung City
Kaohsiung Chang Gung Memorial Hospital,Substudy-03
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
ACTIVE_NOT_RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
RECRUITING
Kaohsiung City
National Taiwan University Hospital,Substudy-01
RECRUITING
Taipei
National Taiwan University Hospital,Substudy-02
ACTIVE_NOT_RECRUITING
Taipei
Turkey
Memorial Ankara Hastanesi,Substudy-01
RECRUITING
Ankara
Memorial Ankara Hospital,Substudy-03
RECRUITING
Ankara
Dicle University Medical Faculty,Substudy-03
RECRUITING
Diyarbakır
Dicle University,Substudy-01
RECRUITING
Diyarbakır
Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01
RECRUITING
Konya
Necmettin Erbakan Universitesi,Substudy-03
RECRUITING
Meram Konya
Gazi University Medical Faculty,Substudy-03
RECRUITING
Yenimahalle
United Kingdom
Birmingham Heartlands Hospital,Substudy-03
RECRUITING
Birmingham
University Hospitals Birmingham NHS Trust,Substudy-01
RECRUITING
Birmingham
University Hospitals Birmingham NHS Trust,Substudy-02
ACTIVE_NOT_RECRUITING
Birmingham
St James University Hospital,,Substudy-01
RECRUITING
Leeds
St. Bartholomew's Hospital,Substudy-01
RECRUITING
London
St. Bartholomew's Hospital,Substudy-02
ACTIVE_NOT_RECRUITING
London
St. Bartholomew's Hospital,Substudy-03
RECRUITING
London
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2023-03-16
Estimated Completion Date: 2029-09
Participants
Target number of participants: 593
Treatments
Experimental: Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)
Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
Experimental: Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)
Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Experimental: Substudy 01: ZIM + ETRUMA
Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Experimental: Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG)
Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.
Active_comparator: Substudy 01: ZIM + Platinum Based Chemotherapy
Expansion Stage Only: Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).~Platinum Based Chemotherapy will be cisplatin or carboplatin and pemetrexed (non-squamous histology) or carboplatin, paclitaxel and nabpaclitaxel (squamous histology).
Experimental: Substudy 02: SG + ZIM + ETRUMA
Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Active_comparator: Substudy 02: Either Docetaxel or SG (Monotherapy Only)
Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.
Experimental: Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
Participants will receive ZIM plus DOM and any one of the chemotherapy (choice of chemotherapy is dependent on histology).~Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
Experimental: Substudy 03 - ZIM + Platinum-based Chemotherapy
Participants will receive ZIM plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).~Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
Active_comparator: Substudy 03: Nivolumab + Platinum-based Chemotherapy
Participants will receive nivolumab plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).~Platinum Based Chemotherapy will be carboplatin and pemetrexed (non-squamous histology) or carboplatin and paclitaxel (squamous histology).
Related Therapeutic Areas
Lung Cancer
Sponsors
Collaborators: Arcus Biosciences, Inc.
Leads: Gilead Sciences

This content was sourced from clinicaltrials.gov

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