Non-small Cell Lung CancerPhase 1NCT04297605
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
A Phase 1 study testing Pembrolizumab, Pemetrexed (Chemotherapy) and Nab-paclitaxel (Chemotherapy) in people with Non-small Cell Lung Cancer, run by University of Rochester at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Pembrolizumab, Pemetrexed (Chemotherapy) and Nab-paclitaxel (Chemotherapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2020to 30 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Rochester
Rochester, New York, 14642
Megan Baumgart, wcictoresearch@urmc.rochester.edu
Megan Baumgart
- Recruiting
University of Rochester
Rochester, New York, 14642
About this study
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
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
- Being tested
- Pembrolizumab, Pemetrexed (Chemotherapy), Nab-paclitaxel (Chemotherapy)
- Keywords
- Eastern Cooperative Oncology Group (ECOG), Non-small Cell Lung Cancer, pembrolizumab, performance status of 2 (PS2)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Drug: Pembrolizumab; Other: Nab-paclitaxel (Chemotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 Months
Secondary outcomes (1)
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.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start15 May 2020
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Baumgart, University of Rochester
- Investigators
- Megan Baumgart, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297605
- Sponsor's protocol ID
- ULUN19148
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04297605
- Acronym / sponsor ID
- ULUN19148
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Eastern Cooperative Oncology Group (ECOG), Non-small Cell Lung Cancer, pembrolizumab, performance status of 2 (PS2)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1: pembrolizumab and Pemetrexed | Experimental | Drug: Pembrolizumab, Other: Pemetrexed (Chemotherapy)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 2: pembrolizumab and Nab-paclitaxel | Experimental | Drug: Pembrolizumab, Other: Nab-paclitaxel (Chemotherapy)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- 4A. For patients with stage IIIc disease, patients are ineligible for or refuse standard treatment with platinum-double chemotherapy and radiation.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab 200 mg | Drug | Experimental 1: pembrolizumab and Pemetrexed, Experimental 2: pembrolizumab and Nab-paclitaxel |
| Pemetrexed (Chemotherapy)500 mg/m2 day 1 of 21 day cycle (for non-squamous only) | Other | Experimental 1: pembrolizumab and Pemetrexed |
| Nab-paclitaxel (Chemotherapy)100 mg/m2 days 1,8 of 21 day cycle x 4 cycles | Other | Experimental 2: pembrolizumab and Nab-paclitaxel |
Primary outcome
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
1 secondary outcome
Percentage of participants with Complete Response or Partial Response
Time frame: 18 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Baumgart principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pembrolizumab, Pemetrexed (Chemotherapy) and Nab-paclitaxel (Chemotherapy) in people with Non-small Cell Lung Cancer, run by University of Rochester at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Baumgart (585-275-4401, Megan_Baumgart@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.