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New treatment option for Lung Cancer
Official title Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer
ClinicalTrials.gov ID: NCT04093167
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The standard or usual treatment for this disease is pembrolizumab given by needle into the veins (IV). Some cancers shed DNA (circulating tumour DNA or ctDNA) or genes (biomarkers) into the blood, and levels of these biomarkers may be able to tell researchers how people respond to treatment with pembrolizumab before they feel worse, or the cancer is worse on imaging tests.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed metastatic NSCLC. Patients with stage III disease are eligible if they are not candidates for surgical...
- Confirmed EGFR and ALK mutation-negative disease based on testing consistent with local guidelines.
- Patients must have a PD-L1 test result from a certified laboratory indicating PD-L1 expression Tumour Proportion Score (TPS) ≥ 50%. Patients with...
- Patients are to be registered prior to starting immunotherapy. Screening ctDNA is to be drawn following registration prior to starting immunotherapy...
- Prior chemotherapy or immunotherapy for non-metastatic disease (e.g. adjuvant and or neoadjuvant therapy) is allowed if at least 6 months have...
You likely can't join if
- Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works...
- Patients with symptomatic central nervous system (CNS) metastases and/or CNS metastases requiring immunosuppressive doses of systemic corticosteroids...
- Patients who are not suitable candidates for treatment with pembrolizumab as a single agent or in combination with standard platinum combination...
- History of significant neurologic or psychiatric disorder that would impair the ability to obtain consent or limit compliance with study requirements.
- Concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents
- Pregnant or lactating women.
See the full eligibility criteria
- Histologically or cytologically confirmed metastatic NSCLC. Patients with stage III disease are eligible if they are not candidates for surgical resection or definitive chemoradiation. Patients with Large Cell...
- Confirmed EGFR and ALK mutation-negative disease based on testing consistent with local guidelines.
- Patients must have a PD-L1 test result from a certified laboratory indicating PD-L1 expression Tumour Proportion Score (TPS) ≥ 50%. Patients with lower PD-L1 TPS scores treated with single agent pembrolizumab consistent...
- Patients are to be registered prior to starting immunotherapy. Screening ctDNA is to be drawn following registration prior to starting immunotherapy and after not more than 2 cycles of the 200mg or 2mg/kg IV Q3W...
- Prior chemotherapy or immunotherapy for non-metastatic disease (e.g. adjuvant and or neoadjuvant therapy) is allowed if at least 6 months have elapsed between the completion of prior therapy and start of pembrolizumab...
- Patients must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic or radiation therapy.
- Previous major surgery is permitted provided that surgery occurred at least 14 days prior to screening of ctDNA and 28 days prior to patient enrollment and that wound healing has occurred.
- Eligible and suitable to receive continued treatment with pembrolizumab OR the addition of chemotherapy to pembrolizumab at the time of registration and again at the time of enrollment and randomization. Patients should...
- Must be ≥ 18 years of age.
- ECOG performance status 0-2.
- Clinically and/or radiologically documented and evaluable disease. Measurable disease as defined by RECIST is not required.
- Imaging investigations including CT of the chest, abdomen and pelvis and MRI/CT of the brain (if known brain metastases) or other scans as necessary to document all sites of disease must be done within 14 days prior to...
- Patients must have RECIST non-PD or clinically stable PD documented prior to enrollment that can continue on IO therapy if assigned by chance to that arm.
- Detectable ctDNA on screening at 6 weeks is required for subsequent enrollment and randomization.
- Adequate hematology and organ function to continue immunotherapy or receive standard platinum combination therapy (must be done prior to registration for ctDNA testing) and prior to enrollment and randomization).
- White Blood Cells ≥ 2.0 x 10\^9/L (2000/μL)
- Absolute neutrophils ≥ 1.5 x 10\^9/L (1500/μL)
- Platelets ≥ 100 x 10\^9/L (100 x 10\^3/μL)
- Bilirubin ≤ 1.5 x ULN (upper limit of normal)\
- AST and/or ALT ≤ 3 x ULN, \< 5 x ULN for patients with liver metastases
- Serum creatinine or Creatinine clearance ≤ 1.5 x ULN OR ≥ 40 mL/min
- Patients must consent to the provision of, and investigator must agree to submit, a representative archival formalin-fixed paraffin block of tumour tissue for correlative analyses when tumour tissue is available.
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to registration to the trial to document their willingness to...
- Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, collection...
- In accordance with CCTG policy, protocol treatment is to begin within 5 working days of patient randomization.
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during protocol treatment and for at least 6 months after the last dose of the protocol treatment. Participants of...
- Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the protocol treatment regimens are eligible for this trial.
- Patients with symptomatic central nervous system (CNS) metastases and/or CNS metastases requiring immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone equivalents). Patients with known central...
- Patients who are not suitable candidates for treatment with pembrolizumab as a single agent or in combination with standard platinum combination chemotherapy according to the current guidance/indications described in...
- History of significant neurologic or psychiatric disorder that would impair the ability to obtain consent or limit compliance with study requirements.
- Concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Greater Sudbury, Ontario, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- Ottawa, Ontario, Canada
- Sault Ste. Marie, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Baltimore, Maryland, United States; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Greater Sudbury, Ontario, Canada; Hamilton, Ontario, Canada and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.