A Pilot 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
Overview
- Phase
- Phase 1
- Intervention
- Pembrolizumab
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- University of Rochester
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Number of participants with Adverse Events as a Measure of Safety and Tolerability
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Megan Baumgart
Assistant Professor
University of Rochester
Eligibility Criteria
Inclusion Criteria
- •Participants must be \>18 years old at time of diagnosis
- •Histologically confirmed non-small cell lung cancer
- •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
Exclusion Criteria
- •Patients with history of autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis
- •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.
- •Patients with cardiovascular, hepatic, or renal systemic diseases that would preclude use of chemotherapy and/or immunotherapy per the treating investigator.
- •The patient must not be on any clinical trials involving other experimental therapies during study treatment
- •Women who are currently pregnant or breast-feeding
- •Patients with any other concurrent medical or psychiatric condition that were deemed inappropriate for entry into the study per the investigator.
- •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.
- •Active infection requiring IV antibiotics
Arms & Interventions
Experimental 1: pembrolizumab and Pemetrexed
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days Pembrolizumab 200 mg and Pemetrexed 500 mg/m2 day 1 of 21 day cycle (for non-squamous only)
Intervention: Pembrolizumab
Experimental 1: pembrolizumab and Pemetrexed
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days Pembrolizumab 200 mg and Pemetrexed 500 mg/m2 day 1 of 21 day cycle (for non-squamous only)
Intervention: Pemetrexed (Chemotherapy)
Experimental 2: pembrolizumab and Nab-paclitaxel
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days Pembrolizumab 200 mg and Nab-paclitaxel 100 mg/m2 days 1,8 of 21 day cycle x 4 cycles followed by pembrolizumab alone
Intervention: Pembrolizumab
Experimental 2: pembrolizumab and Nab-paclitaxel
Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days Pembrolizumab 200 mg and Nab-paclitaxel 100 mg/m2 days 1,8 of 21 day cycle x 4 cycles followed by pembrolizumab alone
Intervention: Nab-paclitaxel (Chemotherapy)
Outcomes
Primary Outcomes
Number of participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 18 Months
Determine the rate of treatment-limiting toxicities in patients with advanced non-small cell lung cancer with ECOG PS 2 who are treated with pembrolizumab and single-agent chemotherapy
Secondary Outcomes
- Percentage of participants with Complete Response or Partial Response(18 Months)