Recruiting

Phase 2

Pembrolizumab vs. ObservationAdjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm

Sponsor:

Greg Durm, MD

Code:

NCT04317534

Conditions

NSCLC, Stage I

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Study Details

Brief summary:

A randomized trial of adjuvant Pembrolizumab following surgical resection versus observation following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm.

Patients will be randomized (1:1) 4-12 weeks following surgery to either:

Arm A: Pembrolizumab 400 mg every 6 weeks × 9 cycles
Arm B: Observation

Stratification factors will include: PD-L1 TPS (<50% vs. ≥50%), and tumor size (1-2 cm vs. >2-4 cm)

Conditions

NSCLC, Stage I

Study ID

NCT04317534

Start date

May 5, 2020

Status verified date

Apr, 2026

Completion date

Apr 8, 2028

Anticipated

Primary completion date

Apr 8, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The participant (or legally acceptable representative if applicable) must provide written informed consent for the study. The participant may also provide consent for future unspecified research samples. However, the participant may participate in the study without participating in the future unspecified research sample collection. NOTE: Initial informed consent will remain valid throughout the 12-week period between surgical resection and study registration unless, in the opinion of the treating investigator, the participant experiences a significant change in medical or mental status.
Males and females age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Patients must have undergone complete surgical resection of their stage I NSCLC between 4-12 weeks prior to registration and have negative surgical margins (R0).

NOTE: Both squamous and non-squamous histologies are allowed into the study. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology".
NOTE: Staging will be according to the AJCC 8th edition.
Pathological tumor size must be 1.0 - 4.0 cm in greatest dimension. NOTE: According to AJCC 8th edition, subjects with lepidic predominant adenocarcinoma should be staged based on their invasive tumor size and not their total tumor size (i.e., subjects with lepidic predominant tumors whose invasive tumor size is less than 1 cm are not eligible, even if their total tumor size is 1.0 cm or greater).
Surgery for this lung cancer must be completed at least 28 days prior to registration.
Baseline CT chest must be performed within 28 days of randomization to ensure no evidence of disease.
Must have either previous NGS and PD-L1 results available using the Dako 22C3 antibody or have archival tissue of surgical specimen from current diagnosis available to perform analyses. PD-L1 results via the Dako 22C3 antibody will be performed per standard of care from a CLIA-accredited laboratory and are required for stratification. If NGS results are not available, subjects must be able to provide at least 10 x 10µm unstained and 1 x 4µm H\&E slides from current diagnosis for future NGS and/or other genetic analyses.
Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. For subjects randomized to the pembrolizumab arm: If there is > 72 hours between the screening test and C1D1, another pregnancy test (urine or serum) must be performed and must be negative before the subject may start C1D1.

NOTE: Females are considered of childbearing potential unless: they are postmenopausal; are surgically sterile; or they have a congenital or acquired condition that prevents childbearing. See Section 5.1.4 for definitions.
NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

Not a woman of childbearing potential (WOCBP) OR
A WOCBP who is using a highly effective contraceptive method (failure rate of <1% per year), or is abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) during the intervention period and for at least 120 days after the last dose of study drug. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study drug. See contraceptive guidance in Section 5.1.4 of the protocol.
Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy after completion of study intervention.

Hepatitis B screening tests are not required unless:

Known history of HBV infection
As mandated by local health authority

Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.

Hepatitis C screening tests are not required unless:

Known history of HCV infection
As mandated by local health authority

HIV-infected participants are eligible but must have well-controlled HIV on anti-retroviral therapy (ART), defined as:
Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at screening.
Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.
It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months before study entry (Day 1/randomization).
Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1/randomization) and agree to continue ART throughout the study.
Note: HIV screening testing is not required unless mandated by local health authority.

As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

Exclusion Criteria:

Current lung cancer is <1 cm or > 4 cm in size or is stage II, III, or IV.
Patients with tumors that are known to harbor actionable EGFR mutations.
Prior chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer.
Has a known active additional malignancy that is progressing or has required active treatment within the past 2 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma in situ, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.

Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
Has had an allogenic tissue/solid organ transplant.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy.
Has active TB (Bacillus Tuberculosis) infection.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.

Study Design

Enrollment

244 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A- Pembrolizumab

Pembrolizumab 400mg IV every 6 weeks x 9 cycles

no intervention: Arm B - Observation

Observation only

Interventions

Pembrolizumab

Pembrolizumab 400mg IV

Primary outcome measure

Disease Free Survival (DFS) [ Time Frame: Up to 3 years from time of randomization ]

Central Contacts and Locations

Central contacts

Greg Durm, MD

317-944-3940 gdurm@iu.edu

Allison Lipps

317-634-5842 alipps@hoosiercancer.org

Locations

Moffit Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Mari Hardy

813-745-1889 marissa.hardy@moffitt.org

Principal Investigator:

Alberto Chiappori, MD

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

John Rosa

312-413-1902 johnrosa@uic.edu

Principal Investigator:

Lawrence Feldman, MD

Indiana University Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Margaret Urich, RN

317-274-4505 muhrich@iu.edu

Principal Investigator:

Greg Durm, MD

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Alisha Demsky

319-384-5461 alisha-demsky@uiowa.edu

Principal Investigator:

Muhammad Furqan, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

KiKi Price

612-626-6541 Price905@umn.edu

Principal Investigator:

Amit Kulkarni, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Kimberly Shields

402-559-8065 kimberly.shields@unmc.edu

Principal Investigator:

Apar Ganti, MD

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Karen Jackson

732-235-4024 jacksoka@cinj.rutgers.edu

Principal Investigator:

Missak Haigentz, MD

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Carly Pilcher

614-366-6174 Carly.Pilcher@osumc.edu

Principal Investigator:

Dwight Owen, MD

Providence Health & Services - Oregon

Recruiting

Portland, Oregon, United States, 97213

Contacts

Kathleen Dronkowski, MSN, FNP

kathleen.dronkowski@providence.org

Principal Investigator:

Rachel Sanborn, MD

Penn State Cancer Institute

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Barbara Husic

717-531-5471 bhusic@pennstatehealth.psu.edu

Principal Investigator:

Patrick Ma, MD

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Gracie Hockenberry

434-297-7784 mgt4n@virginia.edu

Principal Investigator:

Richard Hall, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Carrie Donovan

cdonovan2@vcu.edu

Principal Investigator:

Rachit Shah, MD

Univeristy of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Meghan Dykstra

608-262-9457 mndykstra@wisc.edu

Principal Investigator:

Anne Traynor, MD

More Information

Sponsor

Greg Durm, MD

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Greg Durm, MD on 2026-05-05.