NCT04297605 Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
| NCT ID | NCT04297605 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Rochester |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-05-15 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2020-05-15 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.
Eligibility Criteria
Inclusion Criteria: 1. Participants must be \>18 years old at time of diagnosis 2. Histologically confirmed non-small cell lung cancer 3. ECOG PS 2 4. Clinical staging of IIIc or IV disease. 4A. For patients with stage IIIc disease, patients are ineligible for or refuse standard treatment with platinum-double chemotherapy and radiation. 4B. For patients with stage IV disease, platinum doublet chemotherapy is not appropriate, deemed unsafe by the treating physician, or declined by the patient 4C. Screening lab work must meet the following parameters: 4Ca. Absolute neutrophil count (ANC) ≥1000/mm3 4Cb. Platelet count ≥100,000/mm3 4Cc. CrCl\>50 (if pemetrexed is to be offered) 4Cd. AST and ALT ≤ 2.5 x ULN 4D. Patients with small, asymptomatic brain metastases are eligible 4E. Women of childbearing potential must be negative for pregnancy testing (urine or blood) and agree to use effective contraception. Viable contraception should be used after trial screening, before initiation of chemotherapy, and throughout the duration of active treatment in the study. Non-childbearing potential is defined as (by other than medical reasons): -Amenorrheic \>2 years * Amenorrheic for \<2 years and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation * Post hysterectomy, oophorectomy or tubal ligation. Otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study drug 4F.Participants must read or be read and explained the purposes of the study and sign a statement of informed consent prior to participation. Those who do not read or understand English are eligible and may be consented according to institutional regulations. Exclusion Criteria: 1. Patients with history of autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis 2. Patients on immunosuppressive medication, including steroids (if doses exceed equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to start of treatment are acceptable. 3. Patients with cardiovascular, hepatic, or renal systemic diseases that would preclude use of chemotherapy and/or immunotherapy per the treating investigator. 4. The patient must not be on any clinical trials involving other experimental therapies during study treatment 5. Women who are currently pregnant or breast-feeding 6. Patients with any other concurrent medical or psychiatric condition that were deemed inappropriate for entry into the study per the investigator. 7. Symptomatic, untreated brain metastases. Patients with treated brain metastases may be considered eligible after completion of radiation if steroids have been tapered to less than equivalent of 10 mg of prednisone. 8. Active infection requiring IV antibiotics
Contact & Investigator
Megan Baumgart
PRINCIPAL INVESTIGATOR
University of Rochester
Frequently Asked Questions
Who can join the NCT04297605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04297605 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04297605 currently recruiting?
Yes, NCT04297605 is actively recruiting participants. Contact the research team at Megan_Baumgart@URMC.Rochester.edu for enrollment information.
Where is the NCT04297605 trial being conducted?
This trial is being conducted at Rochester, United States, Rochester, United States.
Who is sponsoring the NCT04297605 clinical trial?
NCT04297605 is sponsored by University of Rochester. The principal investigator is Megan Baumgart at University of Rochester. The trial plans to enroll 60 participants.
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