Trial Outcomes & Findings for Intratumoral Cisplatin for Resectable NSCLC (NCT NCT04809103)
NCT ID: NCT04809103
Last Updated: 2026-02-06
Results Overview
Adverse events as defined using the Common Terminology Criteria for Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
Within 2 weeks of delivery
Results posted on
2026-02-06
Participant Flow
Participant milestones
| Measure |
Intratumoral Cisplatin 10 mg
First dose level in dose escalation study: Intratumoral cisplatin 10 mg.
cis-diamminedichloroplatinum: Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
|
Intratumoral Cisplatin 20 mg
Second dose level in dose escalation study: Intratumoral cisplatin 20 mg.
cis-diamminedichloroplatinum: Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intratumoral Cisplatin for Resectable NSCLC
Baseline characteristics by cohort
| Measure |
Intratumoral Cisplatin 10 mg
n=3 Participants
First dose level
cis-diamminedichloroplatinum: Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
|
Intratumoral Cisplatin 20 mg
n=3 Participants
Second dose level
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=41 Participants
|
3 participants
n=1581 Participants
|
6 participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Within 2 weeks of deliveryAdverse events as defined using the Common Terminology Criteria for Adverse Events
Outcome measures
| Measure |
Intratumoral Cisplatin Arm
n=6 Participants
Single arm approach. There is no comparator or placebo group. Cisplatin will be administered directly into a non-small cell lung cancer, following imaging verification and pathologic diagnosis, during a single bronchoscopic procedure.
cis-diamminedichloroplatinum: Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
|
|---|---|
|
Rate of Dose Limiting Toxicity
|
0 participants
|
SECONDARY outcome
Timeframe: Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic deliveryEvaluation of the tissue response to the drug
Outcome measures
| Measure |
Intratumoral Cisplatin Arm
n=6 Participants
Single arm approach. There is no comparator or placebo group. Cisplatin will be administered directly into a non-small cell lung cancer, following imaging verification and pathologic diagnosis, during a single bronchoscopic procedure.
cis-diamminedichloroplatinum: Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
|
|---|---|
|
Major Pathologic Response
|
0 Participants
|
Adverse Events
Intratumoral Cisplatin 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intratumoral Cisplatin 20 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intratumoral Cisplatin 10 mg
n=3 participants at risk
First dose level
cis-diamminedichloroplatinum: Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
|
Intratumoral Cisplatin 20 mg
n=3 participants at risk
Second dose level
|
|---|---|---|
|
General disorders
Headache
|
0.00%
0/3 • 30 days
All possibly related Grade III CTCAE AEs were considered dose limiting
|
33.3%
1/3 • Number of events 1 • 30 days
All possibly related Grade III CTCAE AEs were considered dose limiting
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • 30 days
All possibly related Grade III CTCAE AEs were considered dose limiting
|
0.00%
0/3 • 30 days
All possibly related Grade III CTCAE AEs were considered dose limiting
|
Additional Information
C. Matthew Kinsey MD, MPH
University of Vermont Medical Center
Phone: 802.656.3521
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place