Plasma-Adapted First-Line Pembro In NSCLC (NCT04166487) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Plasma-Adapted First-Line Pembro In NSCLC
United States40 participantsStarted 2020-01-13
Plain-language summary
This research study is studying to see if a blood test, collected at different times during the treatment of metastatic non-small lung cancer, can be used to detect early response in patients being treated with pembrolizumab and use that information to determine whether patients should continue treatment with pembrolizumab or switch treatment to pembrolizumab in combination with chemotherapy.
The names of the study drugs involved in this study are:
* Pembrolizumab
* Platinum doublet chemotherapy, which may include the following:
* Carboplatin and pemetrexed
* Carboplatin and paclitaxel
The name of the blood test:
\- InVision (Inivata, Ltd.)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- Participants must have histologically or cytologically confirmed stage IV NSCLC (AJCC 8th edition).
\- Participants must have evaluable disease on imaging per RECIST (measurable disease is not required).
* No prior treatment with a systemic anti-cancer therapy of any kind for the treatment of stage IV NSCLC. Prior definitive chemoradiation for locally advanced disease, or prior adjuvant or neoadjuvant therapy for early stage disease is permitted if completed ≥6 months prior to initiating study treatment.
* Age ≥18 years.
* ECOG performance status 0-2 (see Appendix A)
* Candidate for combination chemoimmunotherapy per physician assessment.
* Participants must have normal organ and marrow function as defined below:
\-- absolute neutrophil count ≥1000/mcL
* platelets ≥100,000/mcL
* total bilirubin \<1.3 mg/dL
* creatinine \<1.6 mg/dL
* PD-L1 tumor proportion score (TPS) ≥1%, as determined by a CLIA-laboratory.
* The effects of pembrolizumab on the developing human fetus are unknown. For this reason and because immune checkpoint blockade agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.