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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297605
Recruitment Status : Recruiting
First Posted : March 5, 2020
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Megan Baumgart, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Pembrolizumab Other: Pemetrexed (Chemotherapy) Other: Nab-paclitaxel (Chemotherapy) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: 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)

Drug: Pembrolizumab
Pembrolizumab 200 mg

Other: Pemetrexed (Chemotherapy)
500 mg/m2 day 1 of 21 day cycle (for non-squamous only)

Experimental: 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

Drug: Pembrolizumab
Pembrolizumab 200 mg

Other: Nab-paclitaxel (Chemotherapy)
100 mg/m2 days 1,8 of 21 day cycle x 4 cycles




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage of participants with Complete Response or Partial Response [ Time Frame: 18 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297605


Contacts
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Contact: Megan Baumgart 585-275-4401 Megan_Baumgart@URMC.Rochester.edu

Locations
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United States, New York
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
Contact: Amy Jasek    585-273-1912    Amy_Jasek@urmc.rochester.edu   
Principal Investigator: Megan Baumgart         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Megan Baumgart University of Rochester
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Responsible Party: Megan Baumgart, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04297605    
Other Study ID Numbers: ULUN19148
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Megan Baumgart, University of Rochester:
Eastern Cooperative Oncology Group (ECOG)
Non-small Cell Lung Cancer
pembrolizumab
performance status of 2 (PS2)
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Pembrolizumab
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors