Trial Outcomes & Findings for Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules, the IMPRINT-Lung Study (NCT NCT03634241)

Last Updated: 2026-04-16

Results Overview

Tumor response at 6 months post treatment categorized as partial response (PR), stable disease (SD), or progressive (PD) based on mRECIST criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

6 months after treatment initiation

Results posted on

2026-04-16

Participant Flow

Participants without a history of lung cancer who have indeterminate pulmonary nodules (IPNs) detected by LDCT screening or incidental imaging with a 10-30% cancer probability. Participants with prior stage I-II NSCLC who completed curative treatment (surgery and/or radiation ± chemotherapy) and have persistent IPNs (stable on two CT scans ≥3 months apart) with \>30% cancer probability per the Brock prediction model

A total of 45 participants were enrolled (consented). After exclusions (screen failures, enrollment error, and control arm participants), 40 participants were included in the final analysis and received pembrolizumab.

Participant milestones

Participant milestones
Measure	Single-arm Phase II of Immunotherapy With Pembrolizumab Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo Ctscans and collection of blood samples throughout the trial
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules, the IMPRINT-Lung Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-arm Phase II of Immunotherapy With Pembrolizumab n=40 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo Ctscans and collection of blood samples throughout the trial
Age, Continuous	68.58 years n=193 Participants
Sex: Female, Male Female	34 Participants n=193 Participants
Sex: Female, Male Male	6 Participants n=193 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=193 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=193 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants
Race (NIH/OMB) Asian	2 Participants n=193 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants
Race (NIH/OMB) Black or African American	2 Participants n=193 Participants
Race (NIH/OMB) White	36 Participants n=193 Participants
Race (NIH/OMB) More than one race	0 Participants n=193 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants
Region of Enrollment United States	40 participants n=193 Participants

PRIMARY outcome

Timeframe: 6 months after treatment initiation

Tumor response at 6 months post treatment categorized as partial response (PR), stable disease (SD), or progressive (PD) based on mRECIST criteria.

Outcome measures

Outcome measures
Measure	Single-arm Phase II of Immunotherapy With Pembrolizumab n=40 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo Ctscans and collection of blood samples throughout the trial
6-month CT Assessment (Tumor Response Per mRECIST) PR	1 Participants
6-month CT Assessment (Tumor Response Per mRECIST) SD	36 Participants
6-month CT Assessment (Tumor Response Per mRECIST) PD	2 Participants
6-month CT Assessment (Tumor Response Per mRECIST) Missing	1 Participants

SECONDARY outcome

Timeframe: From treatment initiation through follow-up (Median Follow-Up 29.5 months)

Time from initiation to post treatment lung cancer diagnosis or death from any cause

Outcome measures

Outcome measures
Measure	Single-arm Phase II of Immunotherapy With Pembrolizumab n=40 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo Ctscans and collection of blood samples throughout the trial
Disease Free Survival	NA months Interval 28.3 to Not reached, not estimable

SECONDARY outcome

Timeframe: From treatment initiation to death from any cause, assessed over a follow-up period of up to approximately 34 months

Time from initial treatment to death of any cause

Outcome measures

Outcome measures
Measure	Single-arm Phase II of Immunotherapy With Pembrolizumab n=40 Participants Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo Ctscans and collection of blood samples throughout the trial
Overall Survival	NA months Interval 34.1 to Not reached, not estimable

Adverse Events

Single-arm Phase II of Immunotherapy With Pembrolizumab

Serious events: 3 serious events

Other events: 30 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Single-arm Phase II of Immunotherapy With Pembrolizumab n=40 participants at risk Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo Ctscans and collection of blood samples throughout the trial
Blood and lymphatic system disorders Anemia	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Blood and lymphatic system disorders Lymphocyte Count Decreased	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
General disorders Endocrine Disorder	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Metabolism and nutrition disorders Metabolism and Nutrition Disorder	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)

Other adverse events

Other adverse events
Measure	Single-arm Phase II of Immunotherapy With Pembrolizumab n=40 participants at risk Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo Ctscans and collection of blood samples throughout the trial
Blood and lymphatic system disorders White blood cell decreased	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Renal and urinary disorders Urinary Retention	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Renal and urinary disorders Urinary Tract Pain	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Vascular disorders Vascular Disorders	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Gastrointestinal disorders Abdominal Distention	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Gastrointestinal disorders Abdominal Pain	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Investigations Alanine Aminotransferase Increased	20.0% 8/40 • Number of events 8 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Investigations Alkaline Phophatase Increased	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Blood and lymphatic system disorders Anemia	5.0% 2/40 • Number of events 2 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Metabolism and nutrition disorders Anorexia	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 4/40 • Number of events 4 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Investigations Aspartate Aminotransferase increased	17.5% 7/40 • Number of events 7 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Investigations Blood Bilirubin Increased	17.5% 7/40 • Number of events 7 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Cardiac disorders Cardiac disorders-other	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Gastrointestinal disorders Colitis	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Gastrointestinal disorders Cough	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Investigations Creatnine Increased	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Gastrointestinal disorders Diarrhea	7.5% 3/40 • Number of events 3 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
General disorders Dry Eye	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Gastrointestinal disorders Dry Mouth	7.5% 3/40 • Number of events 3 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Skin and subcutaneous tissue disorders Dry Skin	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Gastrointestinal disorders Dysphagia	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Endocrine disorders Endocrine Disorders	5.0% 2/40 • Number of events 2 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
General disorders Fatigue	45.0% 18/40 • Number of events 18 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
General disorders Fever	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Nervous system disorders Gait Disturbance	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Gastrointestinal disorders Gastrointestinal	5.0% 2/40 • Number of events 2 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
General disorders General Disorders	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Nervous system disorders Headache	5.0% 2/40 • Number of events 2 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Metabolism and nutrition disorders Hyperglycemia	10.0% 4/40 • Number of events 4 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Vascular disorders Hypertension	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
General disorders Hypothyroidism	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
General disorders Immune System Disorders	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Investigations INR Increased	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Investigations Investigations	25.0% 10/40 • Number of events 10 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Musculoskeletal and connective tissue disorders Musculoskeletal disorders	10.0% 4/40 • Number of events 4 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Gastrointestinal disorders Nausea	10.0% 4/40 • Number of events 4 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
General disorders Pain	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Musculoskeletal and connective tissue disorders Pain in Extremity	5.0% 2/40 • Number of events 2 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Skin and subcutaneous tissue disorders Paronychia	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Skin and subcutaneous tissue disorders Pruritus	15.0% 6/40 • Number of events 6 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Skin and subcutaneous tissue disorders Rash Acnieform	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Skin and subcutaneous tissue disorders Rash Maculopapular	17.5% 7/40 • Number of events 7 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Cardiac disorders Sinus Bradycardia	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Skin and subcutaneous tissue disorders Skin disorders	5.0% 2/40 • Number of events 2 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)
Skin and subcutaneous tissue disorders Skin Ulceration	2.5% 1/40 • Number of events 1 • From treatment initiation through last follow-up. Adverse events and deaths were assessed over a follow-up period with a median of 25.9 months (range: 17.8 to 34.1 months)

Additional Information

Jianjun Zhang, MD, PHD

The University of Texas MD Anderson Cancer Center

Phone: (713) 563-6096

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place