Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
Recruiting
Observational Study
Lung CancerNSCLCNSCLC Stage IV
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 110
Sex
Any
Study type
Observational
Participants needed
25 (estimated)
Sponsor
Jun Zhang, MD, PhD · Other
Who this trial is looking for
This trial is looking for patients with advanced lung cancer who have never received immunotherapy before. Participants will undergo a procedure to provide tissue samples and will receive specific immunotherapy treatments as part of their care.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced metastatic lung cancer.
I have never received immunotherapy before.
I am at least 18 years old.
I can understand this study and give consent.
I have lesions that can be safely biopsied.
I have at least one target lesion to evaluate treatment response.
My overall health status is good (ECOG 0-2).
I agree to use contraception if needed.
You may not be able to join if
I am currently incarcerated.
I cannot make medical decisions or communicate.
I am not following the study instructions as judged by the investigator.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
* Patients with advanced/metastatic NSCLC
* Must be immunotherapy naive
* Males and females age ≥ 18 years
* ECOG P…
Inclusion Criteria:
* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
* Patients with advanced/metastatic NSCLC
* Must be immunotherapy naive
* Males and females age ≥ 18 years
* ECOG Performance Status 0 - 2
* Measurable disease by RECIST 1.1
* Must have a lesion (either primary or metastatic lesion) that can be safely biopsied to have sufficient tissue (at minimum, 3-4 cores using 20g or larger core biopsy) to generate tumoroids
* Must have at least one target lesion to evaluate treatment response
* Will be receiving anti-PD-1/L1 with or without anti-CTLA-4 per standard of care Adequate organ function defined per standard of care in this setting.
* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception as required/recommended by each immune checkpoint inhibitor used in the setting of standard of care.
Exclusion Criteria:
* Incarcerated
* Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.
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