Recruiting
Phase 1

Chemotherapy with Pembrolizumab

Sponsor:

University of Rochester

Code:

NCT04297605

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Pemetrexed (Chemotherapy)

Nab-paclitaxel (Chemotherapy)

Study Details

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

Study ID

NCT04297605

Start date

May 15, 2020

Status verified date

Jun, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Pembrolizumab

Pembrolizumab 200 mg

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

Primary outcome measure

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

Central Contacts and Locations

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

More Information

Sponsor

University of Rochester

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-06-04.