Description:
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.
Title
- Brief Title: 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
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
ULUN19148
- NCT ID:
NCT04297605
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Pembrolizumab | | Experimental 1: pembrolizumab and Pemetrexed |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Experimental 1: pembrolizumab and Pemetrexed | Experimental | 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) | |
Experimental 2: pembrolizumab and Nab-paclitaxel | Experimental | 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 | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with Adverse Events as a Measure of Safety and Tolerability |
Time Frame: | 18 Months |
Safety Issue: | |
Description: | 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 Outcome Measures
Measure: | Percentage of participants with Complete Response or Partial Response |
Time Frame: | 18 Months |
Safety Issue: | |
Description: | Determine the proportion of patients who achieve a complete or partial response as their best overall response based on RECIST v1.1 criteria will be evaluated. Patients with nonevaluable or unknown response status will be considered nonresponders. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Rochester |
Trial Keywords
- Eastern Cooperative Oncology Group (ECOG)
- Non-small Cell Lung Cancer
- pembrolizumab
- performance status of 2 (PS2)
Last Updated
November 5, 2020