NCT05715229 · Hackensack Meridian Health
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
(G360-IIT)
What this study is about
This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.
View original scientific description
This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.
Interventions
DRUG
Nivolumab
Immunotherapy
DRUG
Ipilimumab
Immunotherapy
DRUG
Carboplatin
Chemotherapy
DRUG
Paclitaxel
Chemotherapy
DRUG
Pemetrexed
Chemotherapy
Primary outcome measures
Progression Free Survival (PFS)
Time frame: Time from randomization to objective disease progression, or death from any cause, whichever first, up to 36 months
To compare progression free survival in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC 2. Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay. 3. Patients will require a baseline Guardant360 CDx test prior to enrollment 4. Patients willing to undergo serial ctDNA testing as required by protocol 5. Patients will be over the age of 18 6. Life expectancy ≥12 weeks 7. Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per the treating investigator. 8. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to randomization 9. ECOG Performance Score ≤2 10. Adequate organ function 11. Hemoglobin \> 9 g/dL 12. Platelets \> 100,000mm3 or 100 x 109/L 13. AST, ALT \< 2.5 x ULN with no liver metastases or \< 5x ULN with the presence of liver metastases 14. Total bilirubin \< 1.5 x ULN if no liver metastases or \<
Where
- Washington D.C., District of Columbia
- Hackensack, New Jersey
- Neptune City, New Jersey
Collaborators
MedSIR
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations