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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT04297605
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg
  • Pemetrexed (Chemotherapy) — OTHER
    500 mg/m2 day 1 of 21 day cycle (for non-squamous only)
  • Nab-paclitaxel (Chemotherapy) — OTHER
    100 mg/m2 days 1,8 of 21 day cycle x 4 cycles

Study Details

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.

Key Dates

Start date
May 15, 2020
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
Jan 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)
  • 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

Primary Outcome Measure

Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 18 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14642
Megan Baumgart
[email protected]
Megan Baumgart (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642-

Find similar trials in Rochester, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Rochester· Rochester, NY

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