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

• ClinicalTrials.gov Identifier: NCT04297605
• Recruitment Status: Recruiting
• First Posted: March 5, 2020
• Last Update Posted: January 5, 2022
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Megan Baumgart, University of Rochester

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Megan Baumgart; University of Rochester

More Information

• Responsible Party: Megan Baumgart, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT04297605
• Other Study ID Numbers: ULUN19148
• First Posted: March 5, 2020
• Last Update Posted: January 5, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

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