Trial Outcomes & Findings for ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting (NCT NCT04241315)

Last Updated: 2023-03-23

Results Overview

The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

112 participants

Primary outcome timeframe

1 day

Results posted on

2023-03-23

Participant Flow

1 subject dosed and withdrawal by subject prior to surgery

Participant milestones

Participant milestones
Measure	Near-Infrared Imaging Group All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Near infrared camera imaging system: Near infrared camera imaging system	No Imaging Group All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
Overall Study STARTED	100	12
Overall Study COMPLETED	100	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Near-Infrared Imaging Group All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Near infrared camera imaging system: Near infrared camera imaging system	No Imaging Group All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Near-Infrared Imaging Group n=100 Participants All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Near infrared camera imaging system: Near infrared camera imaging system	No Imaging Group n=11 Participants All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	5 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	64 Participants n=5 Participants	6 Participants n=7 Participants	70 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 9.68 • n=5 Participants	64 years STANDARD_DEVIATION 9.88 • n=7 Participants	65.9 years STANDARD_DEVIATION 9.67 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	9 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	2 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	11 Participants n=7 Participants	110 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	88 Participants n=5 Participants	8 Participants n=7 Participants	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	11 participants n=7 Participants	111 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who: • Were evaluated under both normal light/palpation and NIR fluorescent light imaging

The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.

Outcome measures

Outcome measures
Measure	Full Analysis Set (FAS) n=100 Participants The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
Clinically Significant Events (CSE)	.530 proportion of participants Interval 0.428 to 0.631

PRIMARY outcome

Timeframe: 1 day

Proportion of FAS subjects with one or more primary NIR fluorescence positive lung nodules (cancerous or non-cancerous, excluding normal lung parenchyma) not detected under normal light and/or palpation

Outcome measures

Outcome measures
Measure	Full Analysis Set (FAS) n=100 Participants The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
Localization of Primary Nodule	.190 proportion of participants Interval 0.118 to 0.281

PRIMARY outcome

Timeframe: 1 day

The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation

Outcome measures

Outcome measures
Measure	Full Analysis Set (FAS) n=100 Participants The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
Identification of Cancerous Synchronous Lesions	.080 proportion of participants Interval 0.035 to 0.152

PRIMARY outcome

Timeframe: 1 day

The proportion of FAS subjects with the identification of a cancerous positive margin that fluoresces within (less than or equal to) 10 mm of the surgical resection staple line

Outcome measures

Outcome measures
Measure	Full Analysis Set (FAS) n=100 Participants The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
Positive Resection Margins	.380 proportion of participants Interval 0.285 to 0.483

SECONDARY outcome

Timeframe: 1 day

Population: Total number of Subjects with Evaluated Tissues

Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.

Outcome measures

Outcome measures
Measure	Full Analysis Set (FAS) n=104 Lesions The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects	.765 proportion of lesions Interval 0.667 to 0.842

SECONDARY outcome

Timeframe: 1 day

Population: Total number of Subjects with Evaluated Tissues

False Positive Rate (FPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed not to be cancer relative to the total number of fluorescent light positive primary nodules and synchronous lesions

Outcome measures

Outcome measures
Measure	Full Analysis Set (FAS) n=108 Lesions The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging
False Positive Rate for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects	.258 proportion of lesions Interval 0.182 to 0.352

Adverse Events

Near-Infrared Imaging Group

Serious events: 7 serious events

Other events: 98 other events

Deaths: 0 deaths

No Imaging Group

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Near-Infrared Imaging Group n=100 participants at risk All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Near infrared camera imaging system: Near infrared camera imaging system	No Imaging Group n=11 participants at risk All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/100 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 2/100 • Number of events 2 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.0% 1/100 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	1.0% 1/100 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Infections and infestations Pneumonia	2.0% 2/100 • Number of events 2 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Infections and infestations Sepsis	1.0% 1/100 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Infections and infestations Urinary tract infection	0.00% 0/100 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Hepatobiliary disorders Hepatic haematoma	1.0% 1/100 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Metabolism and nutrition disorders Hyperglycaemia	1.0% 1/100 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Renal and urinary disorders Urinary retention	0.00% 0/100 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Skin and subcutaneous tissue disorders Subcutaneous emphysema	1.0% 1/100 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration

Other adverse events

Additional Information

Tommy Lee

On Target Laboratories, Inc.

Phone: 214-289-6422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Near-Infrared Imaging Group n=100 participants at risk All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Near infrared camera imaging system: Near infrared camera imaging system	No Imaging Group n=11 participants at risk All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
Injury, poisoning and procedural complications Procedural pain	78.0% 78/100 • Number of events 88 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	90.9% 10/11 • Number of events 12 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Injury, poisoning and procedural complications Incision site pain	13.0% 13/100 • Number of events 26 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 3 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Respiratory, thoracic and mediastinal disorders Pneumothorax	28.0% 28/100 • Number of events 29 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	18.2% 2/11 • Number of events 2 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Respiratory, thoracic and mediastinal disorders Cough	18.0% 18/100 • Number of events 18 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Respiratory, thoracic and mediastinal disorders Dyspnoea	19.0% 19/100 • Number of events 19 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Respiratory, thoracic and mediastinal disorders Hypoxia	12.0% 12/100 • Number of events 12 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.0% 9/100 • Number of events 12 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	5.0% 5/100 • Number of events 5 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Gastrointestinal disorders Nausea	21.0% 21/100 • Number of events 26 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 2 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Gastrointestinal disorders Constipation	17.0% 17/100 • Number of events 17 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	18.2% 2/11 • Number of events 2 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Vascular disorders Hypertension	11.0% 11/100 • Number of events 15 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	18.2% 2/11 • Number of events 2 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Vascular disorders Hypotension	8.0% 8/100 • Number of events 8 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
General disorders Fatigue	7.0% 7/100 • Number of events 7 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 5/100 • Number of events 6 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	0.00% 0/11 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Renal and urinary disorders Urinary retention	7.0% 7/100 • Number of events 8 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 1 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration
Blood and lymphatic system disorders Anaemia	6.0% 6/100 • Number of events 7 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration	9.1% 1/11 • Number of events 2 • Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration