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Immunotherapy treatments for advanced lung cancer

A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer

PHASE2 · Gilead Sciences · NCT05676931

This study is testing different combinations of immunotherapy treatments for people with advanced lung cancer to see how well they work and how safe they are.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences (industry)
Drugs / interventionsprednisone, immunotherapy
Locations58 sites (Birmingham, Alabama and 57 other locations)
Trial IDNCT05676931 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of various immunotherapy combinations in patients with advanced non-small cell lung cancer (NSCLC). Participants will receive treatments including Domvanalimab, Zimberelimab, Quemliclustat, and standard chemotherapy agents. The primary goal is to assess the objective response rate (ORR) and the tolerability of these combination therapies. Eligible patients must have measurable disease and adequate organ function, and they will be monitored closely throughout the treatment process.

Who should consider this trial

Good fit: Ideal candidates are individuals with Stage IV metastatic non-small cell lung cancer who have a good performance status and measurable disease.

Not a fit: Patients with significant underlying medical conditions or those on immunosuppressive medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new effective treatment options for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promise with immunotherapy combinations in lung cancer, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically or cytologically documented Stage IV metastatic, NSCLC
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
* At least one measurable target lesion per RECIST v1.1.
* Adequate organ function
* Participants must be willing to provide adequate tumor tissue

Exclusion Criteria:

* Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous
* Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
* Use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (absorbable topical corticosteroids are not excluded).
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 57 other locations

+8 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 →

Conditions: Advanced Non-Small Cell Lung Cancer, Domvanalimab, Zimberelimab, Quemliclustat, Anti-TIGIT antibody, Anti-PD-1 antibody

Last reviewed 2026-05-15 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.