Clinical trial NCT05633667: Study of Novel Treatment Combinations in Patients With Lung Cancer
Official title: A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Advanced or Metastatic Non-Small-Cell Lung Cancer
Resectable Non-Small-Cell Lung Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Arcus Biosciences, Inc.
First posted: 2022-12-01
Enrollment: 593
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 5 years
measure: Substudy 03: Complete Pathological Response (pCR) Rate
timeFrame: Up to 5 years
Secondary outcomes:
measure: Substudies 01 and 02: Progression-free Survival (PFS) According to RECIST Version 1.1
timeFrame: Up to 5 years
measure: Substudies 01 and 02: Duration of response (DOR) According to RECIST Version 1.1
timeFrame: Up to 5 years
measure: All Substudies: Overall survival (OS)
timeFrame: Up to 5 years
measure: Substudy 03: Event-Free Survival (EFS)
timeFrame: Up to 5 years
measure: Substudy 03: Major Pathological Response (MPR) Rate
timeFrame: Up to 5 years
measure: All Substudies: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs
timeFrame: First dose date up to 24 months plus 100 days
measure: All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities
timeFrame: First dose date up to 24 months plus 100 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates,Substudy-01
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates,Substudy-02
state: Arizona
city: Denver
country: United States
facility: Rocky Mountain Cancer Center,Substudy-01
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center,Substudy-02
state: Colorado
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington,Substudy-03
state: Kentucky
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Siteman Cancer Center,Substudy-01
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Siteman Cancer Center,Substudy-02
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Siteman Cancer Center,Substudy-03
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Siteman Cancer Center
state: Missouri
city: Cincinnati
country: United States
facility: Oncology Hematology Care Clinical Trials, LLC,Substudy-01
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care Clinical Trials, LLC,Substudy-02
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon, PC,Substudy-01
state: Oregon
city: Eugene
country: United States
facility: Oncology Associates of Oregon, PC,Substudy-02
state: Oregon
city: Austin
country: United States
facility: Texas Oncology - Central South,Substudy-01
state: Texas
city: Austin
country: United States
facility: Texas Oncology - Central South,Substudy-02
state: Texas
city: Fairfax
country: United States
facility: US Oncology Investigational Products Center (IPC),Substudy-01
state: Virginia
city: Fairfax
country: United States
facility: US Oncology Investigational Products Center (IPC),Substudy-02
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center,Substudy-01
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center,Substudy-02
state: Washington
city: Porto Alegre
country: Brazil
facility: Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03
city: São Paulo
country: Brazil
facility: Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03
city: São Paulo
country: Brazil
facility: Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital,Substudy-01
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital,Substudy-02
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital,Substudy-01
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital,Substudy-02
city: New Territories
country: Hong Kong
facility: Prince of Wales Hospital,Substudy-01
city: New Territories
country: Hong Kong
facility: Prince of Wales Hospital,Substudy-02
city: Haifa
country: Israel
facility: Rambam Health Care Campus,Substudy-01
city: Haifa
country: Israel
facility: Rambam Health Care Campus,Substudy-02
city: Haifa
country: Israel
facility: Rambam Health Care Campus,Substudy-03
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center,Substudy-01
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center,Substudy-02
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center,Substudy-03
city: Jerusalem
country: Israel
facility: Hadassah University Medical Center,Substudy-03
city: Petah Tiqva
country: Israel
facility: Rabin Medical Center,Substudy-03
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center,Substudy-01
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center,Substudy-02
city: Tel Aviv-Yafo
country: Israel
facility: Tel-Aviv Sourasky Medical Center,Substudy-03
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital,Substudy-01
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital,Substudy-02
city: Goyang
country: Korea, Republic of
facility: National Cancer Center,Substudy-01
city: Goyang
country: Korea, Republic of
facility: National Cancer Center,Substudy-02
city: Goyang
country: Korea, Republic of
facility: National Cancer Center,Substudy-03
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital,Substudy-01
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital,Substudy-03
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital,Substudy-01
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital,Substudy-03
city: Seo-gu
country: Korea, Republic of
facility: Kosin University Gospel Hospital,Substudy-01
city: Seo-gu
country: Korea, Republic of
facility: Kosin University Gospel Hospital,Substudy-03
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System,Substudy-03
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center,Substudy-02
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center,Substudy-03
city: Seoul
country: Korea, Republic of
facility: Asan Medical Centre,Substudy-01
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center,Substudy-01
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center,Substudy-02
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center,Substudy-03
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System,Substudy-01
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System,Substudy-02
city: Seoul
country: Korea, Republic of
facility: Seoul National University,Substudy-01
city: Seoul
country: Korea, Republic of
facility: Seoul National University,Substudy-02
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital,Substudy-01
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital,Substudy-03
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital,Substudy-01
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital,Substudy-02
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital,Substudy-03
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital,Substudy-01
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital,Substudy-02
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital,Substudy-03
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital,Substudy-01
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital,Substudy-02
city: Ankara
country: Turkey
facility: Memorial Ankara Hospital,Substudy-03
city: Diyarbakir
country: Turkey
facility: Dicle University Medical Faculty,Substudy-03
city: Meram Konya
country: Turkey
facility: Necmettin Erbakan Universitesi,Substudy-03
city: Yenimahalle
country: Turkey
facility: Gazi University Medical Faculty,Substudy-03
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital,Substudy-03
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Trust,Substudy-01
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Trust,Substudy-02
city: Leeds
country: United Kingdom
facility: St James University Hospital,,Substudy-01
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital,Substudy-01
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital,Substudy-02
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital,Substudy-03
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: