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

Non-small Cell Lung Cancer Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04297605
• Other study ID #: ULUN19148
• Status: Recruiting
• Phase: Phase 1
• Start date: May 15, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: University of Rochester
• Contact: Megan Baumgart
• Phone: 585-275-4401
• Email: Megan_Baumgart[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Pembrolizumab
Pembrolizumab 200 mg

Other:
• Pemetrexed (Chemotherapy)
500 mg/m2 day 1 of 21 day cycle (for non-squamous only)
• Nab-paclitaxel (Chemotherapy)
100 mg/m2 days 1,8 of 21 day cycle x 4 cycles

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events as a Measure of Safety and Tolerability	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	18 Months
Secondary	Percentage of participants with Complete Response or Partial Response	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.	18 Months