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NCT Number: NCT05633667

Study of Novel Treatment Combinations in Patients With Lung Cancer

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer Advanced or Metastatic Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Resectable Non-Small-Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundação Pio XII - Hospital de Amor,Substudy-01, Barretos, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zimberelimab (ZIM)

Drug

Administered intravenously

Other names: AB122, GS-0122

Domvanalimab (DOM)

Drug

Administered intravenously

Other names: AB154, GS-0154

Sacituzumab Govitecan-hziy (SG)

Drug

Administered intravenously

Other names: GS-0132, IMMU-132

Etrumadenant (ETRUMA)

Drug

Administered orally

Other names: AB928, GS-0928

carboplatin

Drug

Administered intravenously

Cisplatin

Drug

Administered intravenously

Pemetrexed

Drug

Administered intravenously

paclitaxel

Drug

Administered intravenously

Nab-paclitaxel

Drug

Administered intravenously

docetaxel

Drug

Administered intravenously

Nivolumab

Drug

Administered intravenously

Primary outcomes

  1. 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

    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.

  2. Substudy 03: Complete Pathological Response (pCR) Rate

    Time frame: Up to 5 years

    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.

Secondary outcomes

  1. Substudies 01 and 02: 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. Substudies 01 and 02: 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. Substudy 03: Event-Free Survival (EFS)

    Time frame: Up to 5 years

    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.

  5. Substudy 03: Major Pathological Response (MPR) Rate

    Time frame: Up to 5 years

    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.

  6. All Substudies: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Related TEAEs

    Time frame: First dose date up to 24 months plus 100 days

  7. All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities

    Time frame: First dose date up to 24 months plus 100 days

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Arcus Biosciences, Inc.

Registry information

Official study title

A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)

Acronym: VELOCITY-Lung

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Dec 1, 2022
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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