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| ID | Type | Description | Link |
|---|---|---|---|
| MOH_2022-12-13_012231 | Registry Identifier | Israel Clinical Research Site |
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| Name | Class |
|---|---|
| Arcus Biosciences, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM) | Experimental | Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met. |
|
| Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA) | Experimental | Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
|
| Substudy 01: ZIM + ETRUMA | Experimental | Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
|
| Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) | Experimental | Participants will receive ZIM and SG until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met. |
|
| Substudy 01: ZIM + Platinum Based Chemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimberelimab (ZIM) | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as confirmed at least 4 weeks after the first detection of response. | Up to 5 years |
| Substudy 03: Complete Pathological Response (pCR) Rate | pCR is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes as assessed by local pathology review. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Substudies 01 and 02: Progression-free Survival (PFS) According to RECIST Version 1.1 | PFS is defined as the time from the date of randomization until disease progression (PD) or death, whichever comes first. | Up to 5 years |
| Substudies 01 and 02: Duration of response (DOR) According to RECIST Version 1.1 |
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Key Inclusion Criteria:
All Substudies:
Substudy 01: All Experimental arms
Substudy 02: All Experimental arms
Substudy 03: All Experimental arms
Key Exclusion Criteria:
All Substudies:
Substudy 01 and 02
Substudy 03: All Experimental arms
Note: Other protocol defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates,Substudy-02 | Tucson | Arizona | 85711 | United States | ||
| Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03 |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Active Comparator |
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). |
|
| Substudy 02: SG + ZIM + ETRUMA | Experimental | Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
|
| Substudy 02: Either Docetaxel or SG (Monotherapy Only) | Active Comparator | Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met. |
|
| Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy | Experimental | 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). |
|
| Substudy 03 - ZIM + Platinum-based Chemotherapy | Experimental | 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). |
|
| Substudy 03: Nivolumab + Platinum-based Chemotherapy | Active Comparator | 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). |
|
|
| Domvanalimab (DOM) | Drug | Administered intravenously |
|
|
| Sacituzumab govitecan-hziy (SG) | Drug | Administered intravenously |
|
|
| Etrumadenant (ETRUMA) | Drug | Administered orally |
|
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| Carboplatin | Drug | Administered intravenously |
|
| Cisplatin | Drug | Administered intravenously |
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| Pemetrexed | Drug | Administered intravenously |
|
| Paclitaxel | Drug | Administered intravenously |
|
| Nab-paclitaxel | Drug | Administered intravenously |
|
| Docetaxel | Drug | Administered intravenously |
|
| Nivolumab | Drug | Administered intravenously |
|
DOR is defined as the time from the first response (CR or PR) until the first documented PD, or death, whichever comes first. |
| Up to 5 years |
| All Substudies: Overall survival (OS) | OS is defined as the time from the date of randomization until death from any cause. | Up to 5 years |
| Substudy 03: Event-Free Survival (EFS) | Event-Free Survival (EFS) is defined as the time from randomization until any of the following events: any progression precluding surgery or preventing completion of surgery, progression or recurrence of disease after surgery (local or distant), as assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death due to any cause, whichever occurs first. Participants who do not undergo surgery for reasons other than progression will be considered to have had an event at progression or at death. | Up to 5 years |
| Substudy 03: Major Pathological Response (MPR) Rate | MPR rate is defined as the percentage of participants with ≤ 10% residual tumor in lung and lymph nodes at surgery as evaluated by local pathology review. | Up to 5 years |
| All Substudies: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs | First dose date up to 24 months plus 100 days |
| All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities | First dose date up to 24 months plus 100 days |
| Fort Wayne |
| Indiana |
| 46845 |
| United States |
| Baptist Health Lexington,Substudy-03 | Lexington | Kentucky | 40503 | United States |
| Washington University School of Medicine - Siteman Cancer Center,Substudy-01 | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine - Siteman Cancer Center,Substudy-02 | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine - Siteman Cancer Center,Substudy-03 | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine - Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Oncology Hematology Care Clinical Trials, LLC,Substudy-01 | Cincinnati | Ohio | 45242 | United States |
| Oncology Hematology Care Clinical Trials, LLC,Substudy-02 | Cincinnati | Ohio | 45242 | United States |
| Oncology Associates of Oregon, PC,Substudy-01 | Eugene | Oregon | 97401 | United States |
| Oncology Associates of Oregon, PC,Substudy-02 | Eugene | Oregon | 97401 | United States |
| Fundação Pio XII - Hospital de Amor,Substudy-01 | Barretos | 14784-400 | Brazil |
| Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03 | Porto Alegre | 90110-270 | Brazil |
| Hospital Mae de Deus,Substudy-01 | Porto Alegre | 90110-270 | Brazil |
| Hospital Mae de Deus | Porto Alegre | 90110-270 | Brazil |
| Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-01 | Porto Alegre | 90610001 | Brazil |
| Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03 | Porto Alegre | 90610001 | Brazil |
| BP-A Beneficencia Portuguesa De Sao Paulo,Substudy-01 | São Paulo | 1509 | Brazil |
| Fundação Antonio Prudente - Hospital do Câncer AC Camargo,Substudy-01 | São Paulo | 1509 | Brazil |
| Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03 | São Paulo | 1509 | Brazil |
| Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03 | São Paulo | 1509 | Brazil |
| Queen Mary Hospital,Substudy-01 | Hong Kong | 999077 | Hong Kong |
| Queen Mary Hospital,Substudy-02 | Hong Kong | 999077 | Hong Kong |
| Queen Elizabeth Hospital,Substudy-01 | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital,Substudy-02 | Hong Kong | Hong Kong |
| Prince of Wales Hospital,Substudy-01 | New Territories | Hong Kong |
| Prince of Wales Hospital,Substudy-02 | New Territories | Hong Kong |
| Rambam Health Care Campus,Substudy-01 | Haifa | 3525408 | Israel |
| Rambam Health Care Campus,Substudy-02 | Haifa | 3525408 | Israel |
| Rambam Health Care Campus,Substudy-03 | Haifa | 3525408 | Israel |
| Shaare Zedek Medical Center,Substudy-01 | Jerusalem | 9103102 | Israel |
| Shaare Zedek Medical Center,Substudy-02 | Jerusalem | 9103102 | Israel |
| Shaare Zedek Medical Center,Substudy-03 | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center,Substudy-01 | Jerusalem | 91120 | Israel |
| Hadassah University Medical Center,Substudy-03 | Jerusalem | 91120 | Israel |
| Tel Aviv Sourasky Medical Center,Substudy-01 | Tel Aviv | 64239 | Israel |
| Tel Aviv Sourasky Medical Center,Substudy-02 | Tel Aviv | 64239 | Israel |
| Tel-Aviv Sourasky Medical Center,Substudy-03 | Tel Aviv | 64239 | Israel |
| Chungbuk National University Hospital,Substudy-01 | Cheongju-si | 28644 | South Korea |
| Chungbuk National University Hospital,Substudy-02 | Cheongju-si | 28644 | South Korea |
| National Cancer Center,Substudy-01 | Goyang | 410769 | South Korea |
| National Cancer Center,Substudy-02 | Goyang | 410769 | South Korea |
| National Cancer Center,Substudy-03 | Goyang | 410769 | South Korea |
| Chonnam National University Hwasun Hospital,Substudy-01 | Gwangju | 61469 | South Korea |
| Chonnam National University Hwasun Hospital,Substudy-03 | Gwangju | 61469 | South Korea |
| Seoul National University Bundang Hospital,Substudy-01 | Gyeonggi-do | 463-707 | South Korea |
| Seoul National University Bundang Hospital,Substudy-03 | Gyeonggi-do | 463-707 | South Korea |
| Kosin University Gospel Hospital,Substudy-01 | Seogu | 49267 | South Korea |
| Kosin University Gospel Hospital,Substudy-03 | Seogu | 49267 | South Korea |
| Severance Hospital, Yonsei University Health System,Substudy-03 | Seoul | 03722 | South Korea |
| Asan Medical Center,Substudy-02 | Seoul | 05505 | South Korea |
| Asan Medical Center,Substudy-03 | Seoul | 05505 | South Korea |
| Asan Medical Centre,Substudy-01 | Seoul | 05505 | South Korea |
| Samsung Medical Center,Substudy-01 | Seoul | 06351 | South Korea |
| Samsung Medical Center,Substudy-02 | Seoul | 06351 | South Korea |
| Samsung Medical Center,Substudy-03 | Seoul | 06351 | South Korea |
| Severance Hospital, Yonsei University Health System,Substudy-01 | Seoul | 120-752 | South Korea |
| Severance Hospital, Yonsei University Health System,Substudy-02 | Seoul | 120-752 | South Korea |
| Seoul National University,Substudy-02 | Seoul | 463-707 | South Korea |
| Korea University Guro Hospital,Substudy-01 | Seoul | 8308 | South Korea |
| Korea University Guro Hospital,Substudy-03 | Seoul | 8308 | South Korea |
| Changhua Christian Hospital,Substudy-01 | Changhua | 500-06 | Taiwan |
| Changhua Christian Hospital,Substudy-02 | Changhua | 500-06 | Taiwan |
| Changhua Christian Hospital,Substudy-03 | Changhua | 500-06 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01 | Kaohsiung City | 80756 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02 | Kaohsiung City | 80756 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03 | Kaohsiung City | 80756 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital,Substudy-01 | Kaohsiung City | 83301 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital,Substudy-02 | Kaohsiung City | 83301 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital,Substudy-03 | Kaohsiung City | 83301 | Taiwan |
| National Taiwan University Hospital,Substudy-01 | Taipei | 100 | Taiwan |
| National Taiwan University Hospital,Substudy-02 | Taipei | 100 | Taiwan |
| Adana City Training and Research Hospital,Substudy-01 | Adana | 01120 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi,Substudy-01 | Ankara | 06520 | Turkey (Türkiye) |
| Memorial Ankara Hospital,Substudy-03 | Ankara | 06520 | Turkey (Türkiye) |
| Medical Park Samsun,Substudy-01 | Atakum | 55200 | Turkey (Türkiye) |
| Dicle University,Substudy-01 | Diyarbakır | 21100 | Turkey (Türkiye) |
| Dicle University Medical Faculty,Substudy-03 | Diyarbakır | 21280 | Turkey (Türkiye) |
| Necmettin Erbakan University Meram Faculty of Medicine,Substudy-01 | Konya | 42080 | Turkey (Türkiye) |
| Necmettin Erbakan Universitesi,Substudy-03 | Meram Konya | 42080 | Turkey (Türkiye) |
| Gazi University Medical Faculty,Substudy-01 | Yenimahalle | Turkey (Türkiye) |
| Gazi University Medical Faculty,Substudy-03 | Yenimahalle | Turkey (Türkiye) |
| Birmingham Heartlands Hospital,Substudy-03 | Birmingham | B9 5SS | United Kingdom |
| University Hospitals Birmingham NHS Trust,Substudy-01 | Birmingham | B9 5SS | United Kingdom |
| University Hospitals Birmingham NHS Trust,Substudy-02 | Birmingham | B9 5SS | United Kingdom |
| St James University Hospital,,Substudy-01 | Leeds | LS9 7TF | United Kingdom |
| St. Bartholomew's Hospital,Substudy-01 | London | E1 1BB | United Kingdom |
| St. Bartholomew's Hospital,Substudy-02 | London | E1 1BB | United Kingdom |
| St. Bartholomew's Hospital,Substudy-03 | London | E1 1BB | United Kingdom |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C000719848 | zimberelimab |
| C000608132 | sacituzumab govitecan |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| D017239 | Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000077143 | Docetaxel |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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