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Platinum-based Chemotherapy

Novel Treatment Combinations for Lung Cancer (VELOCITY-Lung Trial)

Phase 2

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior systemic treatment for metastatic NSCLC

Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T[3-4]N2) NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

VELOCITY-Lung Trial Summary

This trial tests novel cancer treatments in people with lung cancer. Substudy-01 tests those treatments vs. standard care in those who haven't been treated before. Substudy-02 tests them in those whose cancer has progressed after treatment. New treatments may be added.

Who is the study for?

This trial is for adults with untreated, measurable non-small cell lung cancer (NSCLC), including those with metastatic or resectable stage II-III NSCLC. Participants must have good organ function and performance status, no known genetic mutations treatable by targeted therapies unless previously treated, and agree to use contraception if applicable. Exclusions include prior systemic or radiotherapy for NSCLC, active brain metastases, history of immune checkpoint inhibitor treatment, other cancers, autoimmune diseases, lung conditions like pneumonitis or infections.Check my eligibility

What is being tested?

The study tests novel combinations of drugs Etrumadenant (ETRUMA), Zimberelimab (ZIM), Domvanalimab (DOM) etc., against standard chemotherapy treatments in three substudies: one for first-time treatment in metastatic NSCLC patients; another for those whose cancer progressed after initial therapy; and a third for early-stage patients eligible for surgery. Effectiveness will be measured by tumor response rate or complete pathological response post-treatment.See study design

What are the potential side effects?

Potential side effects may include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation of organs like the lungs or intestines; infusion-related symptoms; blood abnormalities; increased risk of infections due to weakened immunity; and possible allergic responses specific to each drug combination used.

VELOCITY-Lung Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had any systemic treatment for my advanced lung cancer.

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My lung cancer is at an early stage and hasn't been treated yet.

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My planned surgery is a type of lung removal operation.

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My lung cancer diagnosis was confirmed through lab tests.

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My cancer does not have genetic changes treatable with targeted therapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My stage IV NSCLC is not caused by changes in the EGFR or ALK genes.

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I have received targeted therapy for my specific lung cancer mutation.

VELOCITY-Lung Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Substudy 03: Complete Pathological Response (pCR) Rate

Secondary outcome measures

All Substudies: Overall survival (OS)

All Substudies: Percentage of Participants Experiencing Clinical Laboratory Abnormalities

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

+4 more

VELOCITY-Lung Trial Design

9Treatment groups

Experimental Treatment

Active Control

Group I: Substudy 03 - ZIM + Platinum-based ChemotherapyExperimental Treatment4 Interventions

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).

Group II: Substudy 03 - ZIM + DOM + Platinum-based ChemotherapyExperimental Treatment5 Interventions

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).

Group III: Substudy 02: SG + ZIM + ETRUMAExperimental Treatment3 Interventions

Participants will receive SG, ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.

Group IV: Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM)Experimental Treatment3 Interventions

Participants will receive ZIM, SG and DOM until disease progression (PD), unacceptable toxicity, or protocol specified discontinuation criteria are met.

Group V: Substudy 01: ZIM + ETRUMAExperimental Treatment2 Interventions

Participants will receive ZIM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.

Group VI: Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA)Experimental Treatment3 Interventions

Participants will receive ZIM, DOM and ETRUMA until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.

Group VII: Substudy 01: ZIM + Platinum Based ChemotherapyActive Control6 Interventions

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).

Group VIII: Substudy 03: Nivolumab + Platinum-based ChemotherapyActive Control4 Interventions

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).

Group IX: Substudy 02: Either Docetaxel or SG (Monotherapy Only)Active Control2 Interventions

Participants will receive either Docetaxel or SG until PD, unacceptable toxicity, or protocol specified discontinuation criteria are met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

Pemetrexed

2014

Completed Phase 3

~5250

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,082 Total Patients Enrolled

Arcus Biosciences, Inc.Industry Sponsor

41 Previous Clinical Trials

5,669 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,296 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05633667 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Substudy 01: ZIM + Platinum Based Chemotherapy, Substudy 03 - ZIM + DOM + Platinum-based Chemotherapy, Substudy 02: SG + ZIM + ETRUMA, Substudy 03: Nivolumab + Platinum-based Chemotherapy, Substudy 01: Zimberelimab (ZIM) + Sacituzumab govitecan-hziy (SG) + Domvanalimab (DOM), Substudy 01: ZIM + DOM + Etrumadenant (ETRUMA), Substudy 02: Either Docetaxel or SG (Monotherapy Only), Substudy 01: ZIM + ETRUMA, Substudy 03 - ZIM + Platinum-based Chemotherapy

Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05633667 — Phase 2

Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633667 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for this research program?

"According to the clinicaltrials.gov database, enrolment is still open for this trial; it was initiated on March 16th 2023 and last modified on April 11th 2023."

Answered by AI

Is Substudy 01: ZIM + ETRUMA hazardous to human health?

"Our team at Power has assigned Substudy 01: ZIM + ETRUMA a safety rating of 2 due to the presence of clinical data which supports its security, but not yet any information that affirms efficacy."

Answered by AI

Are there multiple venues in the U.S. where this clinical experiment is taking place?

"18 additional locations are participating in this clinical trial, including Washington University School of Medicine - Siteman Cancer Center, Substudy-02 in Cincinnati, Oncology Hematology Care Clinical Trials, LLC and their substudy-01 Fairfax location. Other opportunities to participate exist at Cheongjusi's Oncology Hematology Care Clinical Trials substudy-02 site and fifteen other sites."

Answered by AI

How many participants have been accepted for this experiment thus far?

"Arcus Biosciences, Inc., the sponsor of this study, requires 335 participants who meet all inclusion criteria. The trial will be conducted from various sites such as Washington University School of Medicine - Siteman Cancer Center in Cincinnati and Oncology Hematology Care Clinical Trials located in Fairfax Virginia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Novel Treatment Combinations in Patients With Lung Cancer

2023. "Study of Novel Treatment Combinations in Patients With Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05633667.

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