Study on Using Blood Tests to Guide Pembrolizumab Treatment in Metastatic Non-Small Cell Lung Cancer
Sponsor: Julia K. Rotow, MD
ClinicalTrials ID:NCT04166487
This clinical trial is exploring whether a blood test can help determine the best treatment plan for patients with metastatic non-small cell lung cancer (NSCLC) receiving pembrolizumab. The study aims to see if the test can identify early responses to treatment and guide whether to continue with pembrolizumab alone or in combination with chemotherapy.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is investigating if a blood test, taken at different times during treatment, can detect early responses in patients with metastatic non-small cell lung cancer (NSCLC) being treated with pembrolizumab. This information could help decide if patients should continue with pembrolizumab alone or switch to a combination of pembrolizumab and chemotherapy. The study involves the drugs pembrolizumab and platinum doublet chemotherapy, which may include carboplatin with pemetrexed or paclitaxel. The blood test used is called InVision by Inivata, Ltd.
Description
This is a pilot study conducted at a single institution to see if a blood test can help guide treatment decisions for patients with metastatic non-small cell lung cancer (NSCLC) receiving pembrolizumab. The study involves regular evaluations approximately every 3 weeks and includes the drugs pembrolizumab and platinum doublet chemotherapy, which may include carboplatin with pemetrexed or paclitaxel. The InVision blood test will be used to monitor how patients respond to treatment. Blood samples will be collected at various times before and after treatment. Participants will be involved in the study for up to 12 months, and about 40 people are expected to participate.
Eligibility Criteria
Inclusion Criteria
- Must have stage IV non-small cell lung cancer (NSCLC) confirmed by lab tests.
- Must have disease that can be evaluated by imaging, but measurable disease is not required.
- No prior systemic anti-cancer therapy for stage IV NSCLC, but previous treatments for earlier stages are allowed if completed at least 6 months before starting the study.
- Must be 18 years or older.
- Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Must be a candidate for combination chemoimmunotherapy as assessed by a doctor.
- Must have normal organ and marrow function based on specific blood test results.
- Must have a PD-L1 tumor proportion score (TPS) of 1% or higher.
- Women and men must agree to use effective contraception during the study and for a specified time after treatment.
- Must be able to understand and sign a written informed consent document.
- Must meet specific criteria for treatment continuation at Cycle 3, including specific blood test results and imaging assessments.
Exclusion Criteria
- Cannot have known genetic changes in EGFR, ALK, ROS1, or BRAF.
- Cannot have had chemotherapy or radiotherapy within 1 week before starting the study.
- Cannot be receiving other investigational treatments.
- Cannot have uncontrolled brain metastases or spinal cord compression.
- Cannot have a history of severe allergic reactions to pembrolizumab or similar drugs.
- Cannot have active autoimmune diseases requiring high doses of steroids or other immunosuppressive drugs.
- Cannot have uncontrolled illnesses or psychiatric conditions that would interfere with the study.
- Pregnant or breastfeeding women cannot participate due to potential risks to the baby.
- Cannot have a known history of HIV or AIDS.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Boston Medical Center | 02118 | Boston | Massachusetts |
| Dana-Farber at Steward St. Elizabeth's Medical Center | 02135 | Brighton | Massachusetts |
| Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in clinical affiliation with South Shore Hospital | 02190 | South Weymouth | Massachusetts |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.