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 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ULUN19148
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Eastern Cooperative Oncology Group (ECOG); Non-small Cell Lung Cancer; pembrolizumab; performance status of 2 (PS2)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of participants with Complete Response or Partial Response

  18 Months

Study Arms (2)

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)

Drug: Pembrolizumab; Other: Pemetrexed (Chemotherapy)

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

Drug: Pembrolizumab; Other: Nab-paclitaxel (Chemotherapy)

Interventions

Pemetrexed (Chemotherapy) OTHER

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

Experimental 1: pembrolizumab and Pemetrexed

Nab-paclitaxel (Chemotherapy) OTHER

100 mg/m2 days 1,8 of 21 day cycle x 4 cycles

Experimental 2: pembrolizumab and Nab-paclitaxel

Pembrolizumab DRUG

Pembrolizumab 200 mg

Experimental 1: pembrolizumab and Pemetrexed; Experimental 2: pembrolizumab and Nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be \>18 years old at time of diagnosis
• Histologically confirmed non-small cell lung cancer
• ECOG PS 2
• Clinical staging of IIIc or IV disease.
• A. For patients with stage IIIc disease, patients are ineligible for or refuse standard treatment with platinum-double chemotherapy and radiation.
• B. For patients with stage IV disease, platinum doublet chemotherapy is not appropriate, deemed unsafe by the treating physician, or declined by the patient
• C. Screening lab work must meet the following parameters:
• Ca. Absolute neutrophil count (ANC) ≥1000/mm3
• Cb. Platelet count ≥100,000/mm3
• Cc. CrCl\>50 (if pemetrexed is to be offered)
• Cd. AST and ALT ≤ 2.5 x ULN
• D. Patients with small, asymptomatic brain metastases are eligible
• E. 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

You may not qualify if:

• Patients with history of autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis
• 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.
• Patients with cardiovascular, hepatic, or renal systemic diseases that would preclude use of chemotherapy and/or immunotherapy per the treating investigator.
• The patient must not be on any clinical trials involving other experimental therapies during study treatment
• Women who are currently pregnant or breast-feeding
• Patients with any other concurrent medical or psychiatric condition that were deemed inappropriate for entry into the study per the investigator.
• 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.
• Active infection requiring IV antibiotics

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (2)

University of Rochester

Rochester, New York, 14642, United States

NOT YET RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Pemetrexed; Drug Therapy; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutics

Study Officials

• Megan Baumgart

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Baumgart

CONTACT

585-275-4401; Megan_Baumgart@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: May 15, 2020
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (2)