Study of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)
Lung Cancer, Advanced or Metastatic Non-Small-Cell Lung Cancer, Resectable Non-Small-Cell Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer
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
Sites / Locations
- Arizona Oncology Associates,Substudy-01Recruiting
- Arizona Oncology Associates,Substudy-02Recruiting
- Rocky Mountain Cancer Center,Substudy-01Recruiting
- Rocky Mountain Cancer Center,Substudy-02Recruiting
- Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03Recruiting
- Washington University School of Medicine - Siteman Cancer Center,Substudy-01Recruiting
- Washington University School of Medicine - Siteman Cancer Center,Substudy-02
- Washington University School of Medicine - Siteman Cancer CenterRecruiting
- Oncology Hematology Care Clinical Trials, LLC,Substudy-01Recruiting
- Oncology Hematology Care Clinical Trials, LLC,Substudy-02Recruiting
- Oncology Associates of Oregon, PC,Substudy-01Recruiting
- Oncology Associates of Oregon, PC,Substudy-02Recruiting
- Texas Oncology,Substudy-01Recruiting
- Texas Oncology,Substudy-02Recruiting
- US Oncology Investigational Products Center (IPC),Substudy-01Recruiting
- US Oncology Investigational Products Center (IPC),Substudy-02Recruiting
- Fred Hutchinson Cancer Center,Substudy-01Recruiting
- Fred Hutchinson Cancer Center,Substudy-02Recruiting
- Queen Mary Hospital,Substudy-01Recruiting
- Queen Mary Hospital,Substudy-02Recruiting
- Prince of Wales Hospital,Substudy-02Recruiting
- Rambam Health Care Campus,Substudy-01Recruiting
- Rambam Health Care Campus,Substudy-02
- Shaare Zedek Medical Center,Substudy-01Recruiting
- Shaare Zedek Medical Center,Substudy-02
- Tel Aviv Sourasky Medical Center,Substudy-01Recruiting
- Tel Aviv Sourasky Medical Center,Substudy-02
- Chungbuk National University Hospital,Substudy-01Recruiting
- Chungbuk National University Hospital,Substudy-02Recruiting
- National Cancer Center,Substudy-01Recruiting
- National Cancer Center,Substudy-02
- Asan Medical Center,Substudy-02
- Asan Medical Centre,Substudy-01Recruiting
- Samsung Medical Center,Substudy-01Recruiting
- Samsung Medical Center,Substudy-02
- Severance Hospital, Yonsei University Health System,Substudy-01Recruiting
- Severance Hospital, Yonsei University Health System,Substudy-02
- Seoul National University,Substudy-01Recruiting
- Seoul National University,Substudy-02Recruiting
- Changhua Christian Hospital,Substudy-01Recruiting
- Changhua Christian Hospital,Substudy-02
- Kaohsiung Chang Gung Memorial Hospital,Substudy-01Recruiting
- Kaohsiung Chang Gung Memorial Hospital,Substudy-02
- National Taiwan University Hospital,Substudy-01Recruiting
- National Taiwan University Hospital,Substudy-02
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)
Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)
Substudy 01: ZIM + ETRUMA
Substudy 01: ZIM + Platinum Based Chemotherapy
Substudy 02: SG + ZIM + ETRUMA
Substudy 02: Either Docetaxel or SG (Monotherapy Only)
Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy
Substudy 03 - ZIM + Platinum-based Chemotherapy
Substudy 03: Nivolumab + Platinum-based Chemotherapy
Participants will receive ZIM, SG and DOM until disease progression (PD)/disease recurrence or unacceptable toxicity.
Participants will receive ZIM, DOM and ETRUMA until PD/disease recurrence or unacceptable toxicity.
Participants will receive ZIM and ETRUMA until PD/disease recurrence or unacceptable toxicity.
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).
Participants will receive SG, ZIM and ETRUMA until PD/disease recurrence or unacceptable toxicity.
Participants will receive either Docetaxel or SG until PD/disease recurrence or unacceptable toxicity.
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).
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).
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).