Clinical Trials /

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

NCT04297605

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
PembrolizumabExperimental 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

NameTypeDescriptionInterventions
Experimental 1: pembrolizumab and PemetrexedExperimentalTreatment 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)
  • Pembrolizumab
Experimental 2: pembrolizumab and Nab-paclitaxelExperimentalTreatment 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
  • Pembrolizumab

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:Not yet 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

March 3, 2020