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Testing new treatment combinations for lung cancer

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

Phase 2 Interventional Gilead Sciences · NCT05633667

This study is testing new combinations of treatments for different types of lung cancer to see if they work better than the usual care.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment270 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences Industry-sponsored
Locations100 sites (Tucson, Arizona and 99 other locations)
Trial IDNCT05633667 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of novel treatment combinations in patients with lung cancer, specifically focusing on advanced or metastatic non-small-cell lung cancer (NSCLC) and resectable NSCLC. The trial consists of three substudies: one for treatment-naive metastatic NSCLC, one for patients whose cancer has progressed after prior treatment, and one for patients with resectable stage II-III NSCLC. Each substudy will compare these novel combinations against standard care to assess response rates and efficacy.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed non-small-cell lung cancer who have not received prior systemic treatment or whose cancer has progressed after treatment.

Not a fit: Patients with known actionable genomic alterations for which targeted therapies are available may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide more effective treatment options for patients with lung cancer, potentially improving survival rates and quality of life.

How similar studies have performed: Previous studies have shown promise in using novel treatment combinations for lung cancer, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Tucson, Arizona and 99 other locations

+50 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lung CancerAdvanced or Metastatic Non-Small-Cell Lung CancerResectable Non-Small-Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.