Trial Title:
Study of Novel Treatment Combinations in Patients With Lung Cancer
NCT ID:
NCT05633667
Condition:
Lung Cancer
Advanced or Metastatic Non-Small-Cell Lung Cancer
Resectable Non-Small-Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Carboplatin
Nivolumab
Pemetrexed
Sacituzumab govitecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zimberelimab (ZIM)
Description:
Administered intravenously
Arm group label:
Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)
Arm group label:
Substudy 01: ZIM + ETRUMA
Arm group label:
Substudy 01: ZIM + Platinum Based Chemotherapy
Arm group label:
Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG)
Arm group label:
Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)
Arm group label:
Substudy 02: SG + ZIM + ETRUMA
Arm group label:
Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
Arm group label:
Substudy 03 - ZIM + Platinum-based Chemotherapy
Other name:
AB122
Other name:
GS-0122
Intervention type:
Drug
Intervention name:
Domvanalimab (DOM)
Description:
Administered intravenously
Arm group label:
Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)
Arm group label:
Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)
Arm group label:
Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
Other name:
AB154
Other name:
GS-0154
Intervention type:
Drug
Intervention name:
Sacituzumab govitecan-hziy (SG)
Description:
Administered intravenously
Arm group label:
Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG)
Arm group label:
Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)
Arm group label:
Substudy 02: Either Docetaxel or SG (Monotherapy Only)
Arm group label:
Substudy 02: SG + ZIM + ETRUMA
Other name:
GS-0132
Other name:
IMMU-132
Intervention type:
Drug
Intervention name:
Etrumadenant (ETRUMA)
Description:
Administered orally
Arm group label:
Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)
Arm group label:
Substudy 01: ZIM + ETRUMA
Arm group label:
Substudy 02: SG + ZIM + ETRUMA
Other name:
AB928
Other name:
GS-0928
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Administered intravenously
Arm group label:
Substudy 01: ZIM + Platinum Based Chemotherapy
Arm group label:
Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
Arm group label:
Substudy 03 - ZIM + Platinum-based Chemotherapy
Arm group label:
Substudy 03: Nivolumab + Platinum-based Chemotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Administered intravenously
Arm group label:
Substudy 01: ZIM + Platinum Based Chemotherapy
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Administered intravenously
Arm group label:
Substudy 01: ZIM + Platinum Based Chemotherapy
Arm group label:
Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
Arm group label:
Substudy 03 - ZIM + Platinum-based Chemotherapy
Arm group label:
Substudy 03: Nivolumab + Platinum-based Chemotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Administered intravenously
Arm group label:
Substudy 01: ZIM + Platinum Based Chemotherapy
Arm group label:
Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
Arm group label:
Substudy 03 - ZIM + Platinum-based Chemotherapy
Arm group label:
Substudy 03: Nivolumab + Platinum-based Chemotherapy
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Administered intravenously
Arm group label:
Substudy 01: ZIM + Platinum Based Chemotherapy
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Administered intravenously
Arm group label:
Substudy 02: Either Docetaxel or SG (Monotherapy Only)
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
Administered intravenously
Arm group label:
Substudy 03: Nivolumab + Platinum-based Chemotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona Oncology Associates,Substudy-01
Address:
City:
Tucson
Zip:
85711
Country:
United States
Status:
Withdrawn
Facility:
Name:
Arizona Oncology Associates,Substudy-02
Address:
City:
Tucson
Zip:
85711
Country:
United States
Status:
Recruiting
Facility:
Name:
Rocky Mountain Cancer Center,Substudy-01
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Withdrawn
Facility:
Name:
Rocky Mountain Cancer Center,Substudy-02
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
Address:
City:
Fort Wayne
Zip:
46845
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center,Substudy-01
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center,Substudy-02
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center,Substudy-03
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology Care Clinical Trials, LLC,Substudy-01
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology Care Clinical Trials, LLC,Substudy-02
Address:
City:
Cincinnati
Zip:
45242
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Associates of Oregon, PC,Substudy-01
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Associates of Oregon, PC,Substudy-02
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology - Central South,Substudy-01
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Withdrawn
Facility:
Name:
Texas Oncology - Central South,Substudy-02
Address:
City:
Austin
Zip:
78745
Country:
United States
Status:
Recruiting
Facility:
Name:
US Oncology Investigational Products Center (IPC),Substudy-01
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
US Oncology Investigational Products Center (IPC),Substudy-02
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center,Substudy-01
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center,Substudy-02
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Facility:
Name:
Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03
Address:
City:
Porto Alegre
Zip:
90110-270
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03
Address:
City:
São Paulo
Zip:
1509
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03
Address:
City:
São Paulo
Zip:
1509
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Queen Elizabeth Hospital,Substudy-01
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Queen Elizabeth Hospital,Substudy-02
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Active, not recruiting
Facility:
Name:
Queen Mary Hospital,Substudy-01
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Queen Mary Hospital,Substudy-02
Address:
City:
Hong Kong
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Prince of Wales Hospital,Substudy-01
Address:
City:
New Territories
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Prince of Wales Hospital,Substudy-02
Address:
City:
New Territories
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Rambam Health Care Campus,Substudy-01
Address:
City:
Haifa
Zip:
3525408
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rambam Health Care Campus,Substudy-02
Address:
City:
Haifa
Zip:
3525408
Country:
Israel
Status:
Active, not recruiting
Facility:
Name:
Rambam Health Care Campus,Substudy-03
Address:
City:
Haifa
Zip:
3525408
Country:
Israel
Status:
Recruiting
Facility:
Name:
Shaare Zedek Medical Center,Substudy-01
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Recruiting
Facility:
Name:
Shaare Zedek Medical Center,Substudy-02
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Active, not recruiting
Facility:
Name:
Shaare Zedek Medical Center,Substudy-03
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah University Medical Center,Substudy-03
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rabin Medical Center,Substudy-03
Address:
City:
Petah Tiqva
Zip:
49100
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Center,Substudy-01
Address:
City:
Tel Aviv-Yafo
Zip:
64239
Country:
Israel
Status:
Recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Center,Substudy-02
Address:
City:
Tel Aviv-Yafo
Zip:
64239
Country:
Israel
Status:
Active, not recruiting
Facility:
Name:
Tel-Aviv Sourasky Medical Center,Substudy-03
Address:
City:
Tel Aviv-Yafo
Zip:
64239
Country:
Israel
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital,Substudy-01
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital,Substudy-02
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cancer Center,Substudy-01
Address:
City:
Goyang
Zip:
410769
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cancer Center,Substudy-02
Address:
City:
Goyang
Zip:
410769
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
National Cancer Center,Substudy-03
Address:
City:
Goyang
Zip:
410769
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chonnam National University Hwasun Hospital,Substudy-01
Address:
City:
Gwangju
Zip:
61469
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chonnam National University Hwasun Hospital,Substudy-03
Address:
City:
Gwangju
Zip:
61469
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital,Substudy-01
Address:
City:
Gyeonggi-do
Zip:
463-707
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital,Substudy-03
Address:
City:
Gyeonggi-do
Zip:
463-707
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Kosin University Gospel Hospital,Substudy-01
Address:
City:
Seo-gu
Zip:
49267
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Kosin University Gospel Hospital,Substudy-03
Address:
City:
Seo-gu
Zip:
49267
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System,Substudy-03
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center,Substudy-02
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Asan Medical Center,Substudy-03
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Centre,Substudy-01
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center,Substudy-01
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center,Substudy-02
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Samsung Medical Center,Substudy-03
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System,Substudy-01
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System,Substudy-02
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Seoul National University,Substudy-01
Address:
City:
Seoul
Zip:
463-707
Country:
Korea, Republic of
Status:
Withdrawn
Facility:
Name:
Seoul National University,Substudy-02
Address:
City:
Seoul
Zip:
463-707
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Guro Hospital,Substudy-01
Address:
City:
Seoul
Zip:
8308
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Guro Hospital,Substudy-03
Address:
City:
Seoul
Zip:
8308
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Changhua Christian Hospital,Substudy-01
Address:
City:
Changhua City
Zip:
500-06
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Changhua Christian Hospital,Substudy-02
Address:
City:
Changhua City
Zip:
500-06
Country:
Taiwan
Status:
Active, not recruiting
Facility:
Name:
Changhua Christian Hospital,Substudy-03
Address:
City:
Changhua City
Zip:
500-06
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
Address:
City:
Kaohsiung City
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
Address:
City:
Kaohsiung City
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
Address:
City:
Kaohsiung City
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Kaohsiung Chang Gung Memorial Hospital,Substudy-01
Address:
City:
Kaohsiung
Zip:
83301
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Kaohsiung Chang Gung Memorial Hospital,Substudy-02
Address:
City:
Kaohsiung
Zip:
83301
Country:
Taiwan
Status:
Active, not recruiting
Facility:
Name:
Kaohsiung Chang Gung Memorial Hospital,Substudy-03
Address:
City:
Kaohsiung
Zip:
83301
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital,Substudy-01
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital,Substudy-02
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Status:
Active, not recruiting
Facility:
Name:
University Hospitals Birmingham NHS Trust,Substudy-01
Address:
City:
Birmingham
Zip:
B9 5SS
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University Hospitals Birmingham NHS Trust,Substudy-02
Address:
City:
Birmingham
Zip:
B9 5SS
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
St James University Hospital,,Substudy-01
Address:
City:
Leeds
Zip:
LS9 7TF
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
St. Bartholomew's Hospital,Substudy-01
Address:
City:
London
Zip:
E1 1BB
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
St. Bartholomew's Hospital,Substudy-02
Address:
City:
London
Zip:
E1 1BB
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
St. Bartholomew's Hospital,Substudy-03
Address:
City:
London
Zip:
E1 1BB
Country:
United Kingdom
Status:
Recruiting
Start date:
March 16, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
Gilead Sciences
Agency class:
Industry
Collaborator:
Agency:
Arcus Biosciences, Inc.
Agency class:
Industry
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633667
https://www.gileadclinicaltrials.com/study/?id=GS-US-624-6376
