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A Study of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05633667
Recruitment Status : Not yet recruiting
First Posted : December 1, 2022
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:

The goal of this platform clinical trial is to test novel treatment combinations in participants with lung cancer. The platform study will consist of 2 initial substudies. New substudies and/or treatment arms may be added to the study through amendment of the master protocol and/or substudy protocols.

Two initial substudies will enroll in parallel:

The goal of Substudy-01 is to see if different combinations of experimental drugs named zimberelimab, domvanalimab, sacituzumab govitecan and etrumadenant are safe and effective for persons with no prior systemic treatment as compared to standard of care.

The goal of Substudy-02 is to see if different combinations of experimental drugs named zimberelimab, sacituzumab govitecan, etrumadenant are safe and effective for persons whose cancer has progressed after receiving previous treatment for metastatic NSCLC (form of cancer that can spread from one part of body to another). The safety and effectiveness will be compared to standard of care.


Condition or disease Intervention/treatment Phase
Lung Cancer Advanced or Metastatic Non-Small-Cell Lung Cancer Biological: Zimberelimab (ZIM) Biological: Domvanalimab (DOM) Biological: Sacituzumab govitecan-hziy (SG) Drug: Etrumadenant (ETRUMA) Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed Drug: Paclitaxel Drug: Nab-paclitaxel Drug: Docetaxel Phase 2

Detailed Description:

This is a Phase 2, randomized platform study to evaluate novel treatment combinations in participants with lung cancer. New substudies and/or treatment arms may be added to the study through amendment of the master protocol and/or substudy protocols.

Each substudy will consist of a preliminary stage and an expansion stage. In the preliminary stage, experimental treatment arms will be compared to the historical standard of care (SOC) benchmark.

In the expansion stage, investigational treatment arms within substudies will be compared to the comparator arm of the substudy. Not all treatment arms from preliminary stage will proceed to the expansion stage.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)
ZIM 360 mg and DOM 1200 mg on Day 1 of each 21-day cycle, up to 35 treatment cycles, plus SG 10 mg/kg on Days 1 and 8 of each 21-day cycle, until disease progression (PD) or unacceptable toxicity.
 Biological: Zimberelimab (ZIM)
Administered intravenously
Other Names:
  • AB122
  • GS-0122

Biological: Domvanalimab (DOM)
Administered intravenously
Other Names:
  • AB154
  • GS-0154

Biological: Sacituzumab govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132
Experimental: Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)
ZIM 360 mg plus DOM 1200 mg on Day 1 each 21-day cycle up to 35 treatment cycles and ETRUMA 150 mg, daily in each 21-day cycle, until PD or unacceptable toxicity.
 Biological: Zimberelimab (ZIM)
Administered intravenously
Other Names:
  • AB122
  • GS-0122

Biological: Domvanalimab (DOM)
Administered intravenously
Other Names:
  • AB154
  • GS-0154

Drug: Etrumadenant (ETRUMA)
Administered orally
Other Names:
  • AB928
  • GS-0928
Experimental: Substudy 01: ZIM + ETRUMA
ZIM 360 mg on Day 1 of each 21-day cycle up to 35 treatment cycles plus ETRUMA 150 mg, daily in each 21-day cycle, until PD or unacceptable toxicity.
 Biological: Zimberelimab (ZIM)
Administered intravenously
Other Names:
  • AB122
  • GS-0122

Drug: Etrumadenant (ETRUMA)
Administered orally
Other Names:
  • AB928
  • GS-0928
Active Comparator: Substudy 01: ZIM + Platinum Based Chemotherapy

Expansion Stage Only: ZIM 360 mg on Day 1 of each 21-day cycle for a maximum of 35 treatment cycles plus any one of the chemotherapy (choice of chemotherapy is dependent on histology).

  • Participants with non-squamous histology will receive:

    • Cisplatin 75 mg/m^2 or carboplatin area under the curve (AUC) 5 plus pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle. Cisplatin/carboplatin will be administered for a maximum of 4 treatment cycles. Pemetrexed continued 4 cycles until PD or unacceptable toxicities.

OR,

  • Participants with squamous histology will receive:

    • Carboplatin AUC 6 with paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle or nab-paclitaxel 100 mg/m^2 on Days 1, 8 and 15 of each 21-day cycle. Carboplatin, paclitaxel, and nab-paclitaxel will be administered for a maximum of 4 treatment cycles.
 Biological: Zimberelimab (ZIM)
Administered intravenously
Other Names:
  • AB122
  • GS-0122

Drug: Carboplatin
Administered intravenously

Drug: Cisplatin
Administered intravenously

Drug: Pemetrexed
Administered intravenously

Drug: Paclitaxel
Administered intravenously

Drug: Nab-paclitaxel
Administered intravenously
Experimental: Substudy 02: SG + ZIM + ETRUMA
ZIM 360 mg on Day 1 of each 21-day cycle up to 35 treatment cycles plus SG 10 mg/kg on Days 1 and 8 in each 21-day cycle, and ETRUMA 150 mg, daily until PD or unacceptable toxicity.
 Biological: Zimberelimab (ZIM)
Administered intravenously
Other Names:
  • AB122
  • GS-0122

Biological: Sacituzumab govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132

Drug: Etrumadenant (ETRUMA)
Administered orally
Other Names:
  • AB928
  • GS-0928
Active Comparator: Substudy 02: Either Docetaxel or SG (Monotherapy Only)
Expansion Stage Only: Either SG 10 mg/kg on Day 1 and Day 8 of each 21-day cycle or Docetaxel 75 mg/m^2 on Day 1 of each 21-day cycle, until PD or unacceptable toxicity.
 Biological: Sacituzumab govitecan-hziy (SG)
Administered intravenously
Other Names:
  • GS-0132
  • IMMU-132

Drug: Docetaxel
Administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. All Substudies: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 5 years ]
    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.


Secondary Outcome Measures :
  1. All Substudies: Progression-free Survival (PFS) According to RECIST Version 1.1 [ Time Frame: Up to 5 years ]
    PFS is defined as the time from the date of randomization until disease progression (PD) or death, whichever comes first.

  2. All Substudies: Duration of response (DOR) According to RECIST Version 1.1 [ Time Frame: Up to 5 years ]
    DOR is defined as the time from the first response (CR or PR) until the first documented PD, or death, whichever comes first.

  3. All Substudies: Overall survival (OS) [ Time Frame: Up to 5 years ]
    OS is defined as the time from the date of randomization until death from any cause.

  4. All Substudies: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 24 months plus 100 days ]
  5. All Substudies: Percentage of Participants Experiencing Related Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 5 years plus 100 days ]
  6. All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities [ Time Frame: First dose date up to 5 years plus 100 days ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

All Substudies:

  • Histologically or cytologically documented non-small-cell lung cancer (NSCLC) with evidence of stage IV disease.
  • No known actionable genomic alterations for which approved therapies are available.
  • No prior systemic treatment for metastatic NSCLC.
  • Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
  • Measurable disease as per response evaluation criteria in solid tumors (RECIST) 1.1 criteria.
  • 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

  • For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.

Substudy 02: All Experimental arms

  • In individuals with nonsquamous histology, individuals with EGFR, ALK, or any other known actionable genomic alterations must have received treatment with at least 1 approved tyrosine kinase inhibitor (TKI) appropriate to the genomic alteration.
  • Progression or disease recurrence after platinum-based chemotherapy with anti-PD-1 or anti-PD-L1 antibody OR sequential treatment (in any order).

Key Exclusion Criteria:

All Substudies:

  • Mixed small-cell lung cancer and NSCLC histology.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Received previous anticancer therapy within 4 weeks prior to enrollment.
  • 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.

Note: Other protocol defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05633667


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05633667    
Other Study ID Numbers: GS-US-624-6376
First Posted: December 1, 2022    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Carboplatin
 Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors