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Study of Novel Treatment Combinations in Patients With Lung Cancer

This study is testing new combinations of treatments for people with lung cancer. It includes different groups: those with advanced lung cancer who haven't had treatment, those whose advanced lung cancer has progressed after previous treatment, and those with early-stage lung cancer that can be removed by surgery. The treatments being studied are zimberelimab, domvanalimab, sacituzumab govitecan-hziy, etrumadenant, and carboplatin. Researchers want to see how well these combinations shrink tumors or lead to a complete disappearance of cancer cells. To join, you must have non-small-cell lung cancer (NSCLC) and a good general health status. The study aims to enroll 192 participants.

Study design
This is an interventional study comparing different novel treatment combinations against standard care in various groups of lung cancer patients. It aims to enroll 192 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure how well the treatments work.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05633667

Study of Novel Treatment Combinations in Patients With Lung Cancer

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Gilead Sciences
~192 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Zimberelimab (ZIM)Domvanalimab (DOM)Sacituzumab govitecan-hziy (SG)Etrumadenant (ETRUMA)CarboplatinCisplatin

At a glance

Recruiting sites
0 of 89 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Up to 5 years
+1 more outcome measured

Conditions

Lung Cancer
Advanced or Metastatic Non-Small-Cell Lung Cancer
Resectable Non-Small-Cell Lung Cancer

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Where it's being run

89 sites across 13 states
South Korea23
Israel11
Taiwan11
Brazil10
Turkey (Türkiye)10
United Kingdom7
Hong Kong6
Missouri4

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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.
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.

Exclusion

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.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Received previous anticancer therapy within 4 weeks prior to enrollment.
NSCLC previously treated with systemic therapy or radiotherapy.
Received prior treatment with any anti-PD-(L)-1 or other immune checkpoint inhibitors (CPIs).

What this trial measures

  • Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1Up 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.

  • Substudy 03: Complete Pathological Response (pCR) RateUp 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.