Proteomic-guided Therapy for Lung Cancer

Overseen By Surbhi Singhal, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Davis

Must be taking: Immune checkpoint inhibitors

Disqualifiers: ALK, EGFR, HER2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating advanced non-small cell lung cancer by using body proteins (proteomics) to guide therapy. Researchers aim to determine if this method can help patients live longer without their cancer worsening compared to usual care. One group will receive a special immune therapy (systemic immune checkpoint inhibitor-based therapy) guided by protein markers, while the other group will receive standard treatment. Individuals with untreated advanced lung cancer that cannot be surgically removed and who are eligible for immune therapy may be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments called immune checkpoint inhibitors (ICIs) can cause some side effects. A review of studies found that serious side effects occur more frequently with ICIs than with chemotherapy alone. However, ICIs have helped many people with lung cancer live longer.

While ICI treatments carry risks of side effects, the benefits often outweigh them. Serious side effects can include tiredness, skin rash, or inflammation, but these vary among individuals. Considering these potential risks and benefits is important when deciding to join a trial. Consulting a healthcare provider can help in making the best decision for one's health. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about this trial because it uses a proteomic-guided approach to tailor immune checkpoint inhibitor (ICI) therapy for lung cancer patients. Unlike standard treatments that rely on generic biomarker assessments, this method uses advanced tools like PROphet CB and CARG-TT to predict how patients will respond to ICIs. This personalized strategy aims to enhance effectiveness, potentially leading to better outcomes by matching the right therapy to the right patient more accurately than ever before.

What evidence suggests that this trial's treatments could be effective for advanced non-small cell lung cancer?

This trial will compare systemic immune checkpoint inhibitor (ICI)-based therapy, guided by PROphet CB and CARG-TT, with the standard of care for treating non-small cell lung cancer (NSCLC). Studies have shown that ICIs can effectively treat NSCLC. Research indicates that ICIs can extend patient survival more than chemotherapy alone. Specifically, one study found that treatments with ICIs led to better survival rates, with patients living longer than those who only received chemotherapy. The benefits were more pronounced in certain groups, with low-risk patients experiencing a 65.09% improvement. These findings suggest that ICIs could be a promising treatment option for patients with advanced NSCLC. ^{6 7 8 9 10}

Who Is on the Research Team?

Surbhi Singhal, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for individuals with advanced non-small cell lung cancer who haven't had treatment before. Specific details about eligibility criteria are not provided, but typically participants need to meet certain health standards and may be required to undergo specific tests or assessments as part of the inclusion process.

Inclusion Criteria

Ability to understand and willingness to sign the informed consent form (ICF)

Stated ability and willingness to adhere to all protocol requirements while on study

My lung cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

Medical comorbidities precluding immune checkpoint inhibitor-based therapy per treating investigator's discretion

Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on study

My tumor has a specific genetic change.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive systemic therapy informed by PROphet CB and CARG-TT or standard of care systemic therapy

12 months

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

What Are the Treatments Tested in This Trial?

Interventions

• Systemic (ICI)-based therapy

Trial Overview The study compares a new approach using systemic therapy guided by the PROphet CB assay and CARG-TT assessment against the standard care for lung cancer. It's designed to see if this personalized treatment can extend the time patients live without their disease getting worse over a period of 12 months.

How Is the Trial Designed?

Group I: Systemic immune checkpoint inhibitor (ICI)-based therapy informed by PROphet CB and CARG-TT Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Standard of care (SOC) biomarker assessment and subsequent selection of SOC systemic therapy.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12491310/

Real-world outcomes of immune checkpoint inhibitors as ... The prognosis of extensive-stage SCLC (ES-SCLC) is extremely poor, with a median overall survival (OS) of only 6–10 months (8) and a five-year ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666364325000062

Impact of Immune Checkpoint Inhibitors and Local Radical ... An ICI-based systemic treatment strategy (±LRT) is associated with improved survival compared with chemotherapy-only (±LRT) for patients with sOMD NSCLC.

3. nature.com nature.com/articles/s41591-024-03398-5

Prediction of checkpoint inhibitor immunotherapy efficacy ... Furthermore, the clinical benefit rates significantly differed in each risk group across tumor types—low-risk, 65.09%; moderate-risk, 52.20%; ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2785694

Uptake and Survival Outcomes Following ICI Therapy ... Median OS was 9.72 months for ICI monotherapy, 9.33 months for ICI combination therapy, and 8.75 months for non-ICI therapy (Table). During the ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00013-6/fulltext

Efficacy and safety of immune checkpoint inhibitors in ... Results from phase 3 RCTs revealed that ICIs significantly improved overall survival (OS) compared to chemotherapy, regardless of race, histological type, ICI ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12479475/

a systematic review and network meta-analysis - PMC Treatment-related grade≥3 adverse events occurred more frequently with immunotherapy versus chemotherapy alone. Furthermore, our findings ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025000136

Efficacy and safety of immune checkpoint inhibitors in ... Results from phase 3 RCTs revealed that ICIs significantly improved OS (hazard ratio [HR] = 0.78, 95% confidence interval [CI]: 0.74–0.82) and progression-free ...

8. esmoopen.com esmoopen.com/article/S2059-7029(22)00083-7/fulltext

Efficacy and safety of first-line checkpoint inhibitors-based ... Regarding OS-NMA, cemiplimab ranked first with a 76.6% likeliness to be the most effective treatment (HR versus CT = 0.33, 95% CrI 0.14-0.75) ...

9. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1512468/full

Efficacy and safety of immune checkpoint inhibitors for ... Conclusions: These findings indicate that ICI+antiangiogenesis+chemo may be potentially beneficial for patients with EGFR-mutated NSCLC. However ...

10. link.springer.com link.springer.com/article/10.1007/s00262-025-04143-8

Efficacy and safety of two-year fixed versus continuous ... Four RWEs compared survival outcomes between 2 year fixed and continuous cohorts and found no difference. Patients who completed 2 years of ...