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ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
Phase 3 trial testing OTL38 for Injection in Lung Neoplasms in 112 participants. Completed in 1 November 2021.
| Lead sponsor | On Target Laboratories, LLC |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 112 |
| Start date | 26 March 2020 |
| Primary completion | 7 October 2021 |
| Estimated completion | 1 November 2021 |
| Sites | 12 locations across United States |
On Target Laboratories, LLC — full company profile →
18 and older, any sex, with Lung Neoplasms or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Full Analysis Set (FAS) | .530 | .428 – .631 |
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
| Group | Value | 95% CI |
|---|---|---|
| Fully Analysis Set (FAS) | .190 | .118 – .281 |
The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation
| Group | Value | 95% CI |
|---|---|---|
| Fully Analysis Set (FAS) | .080 | .035 – .152 |
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
| Group | Value | 95% CI |
|---|---|---|
| Fully Analysis Set (FAS) | .380 | .285 – .483 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Fully Analysis Set (FAS) | .765 | .667 – .842 |
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
| Group | Value | 95% CI |
|---|---|---|
| Fully Analysis Set (FAS) | .258 | .182 – .352 |
Time frame: Adverse events were collected from time of screening through 28 days (+/- 4 days) post-study drug administration. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Near-Infrared Imaging Group | No Imaging Group |
|---|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Hepatic haematoma | Hepatobiliary disorders | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Urinary retention | Renal and urinary disorders | — | — |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | — | — |
| Reaction | System | Near-Infrared Imaging Group | No Imaging Group |
|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Incision site pain | Injury, poisoning and procedural complications | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Fatigue | General disorders | — | — |
| Urinary retention | Renal and urinary disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Pulmonary air leakage | Respiratory, thoracic and mediastinal disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Pleural effusion, Pneumonia, Haemothorax, Dyspnoea, Pulmonary air leakage, Sepsis, Urinary tract infection, Hepatic haematoma.
Data from ClinicalTrials.gov NCT04241315 adverse events section.
This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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