Phase 2 Study of EC145 Alone Versus EC145+Docetaxel Versus Docetaxel Alone in Participants With FR(++) 2nd Line Non Small Cell Lung Cancer

NCT01577654 | Completed Phase 2 DMC

• 2 other identifiers: 8109-0032012-000966-40
• Study Type: interventional
• Target: 203
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test the activity of single-agent EC145 and the combination of EC145 plus docetaxel against the current standard docetaxel in second line Non Small Cell Lung Cancer (NSCLC) (adenocarcinoma, squamous, adenosquamous or adenocarcinoma with other NSCLC variants of the lung) in participants with all target lesions expressing the folate receptor \[FR(++)\].

Conditions

Non Small Cell Lung Cancer

Keywords

adenocarcinoma; squamous; adenosquamous; adenocarcinoma with other NSCLC variants; EC145; EC20; Vintafolide; Etarfolatide

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS)based on investigator assessment using RECIST v1.1

  Disease assessment will be conducted via CT/ MRI every 6 weeks while on study. Participants who come off study due to any other reason except progression of disease or death will be followed via CT/ MRI every 6 weeks until disease progression or until start of new therapy.

  From date of baseline disease assessment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 26 months

Secondary Outcomes (6)

• Compare overall response rate of participants between treatment arms.

  up to 26 months

• Compare disease control rate of participants between treatment arms.

  up to 26 months

• Compare duration of response of participants between treatment arms.

  up to 26 months

• Compare duration of disease control of participants between treatment arms.

  up to 26 months

• Compare overall survival of participants between treatment arms.

  up to 26 months

Study Arms (3)

Arm A: EC145 alone

EXPERIMENTAL

EC145 alone

Drug: EC145; Drug: EC20

Arm B: EC145 + Docetaxel

EXPERIMENTAL

EC145 + Docetaxel

Drug: EC145 + Docetaxel; Drug: EC20

Arm C: Docetaxel alone

ACTIVE COMPARATOR

Docetaxel alone

Drug: Docetaxel; Drug: EC20

Interventions

EC145 DRUG

2.5 mg on Days 1,4,8,11 (Weeks 1 and 2 q3 weeks)

Also known as: Vintafolide

Arm A: EC145 alone

EC145 + Docetaxel DRUG

EC145 2.5 mg on Days 1,4,8,11 (Weeks 1 and 2 q3 weeks) + Docetaxel 75 mg/m2 IV Day 1 q 3 weeks

Also known as: Vintafolide, Taxotere

Arm B: EC145 + Docetaxel

Docetaxel DRUG

75 mg/m2 IV Day 1 q 3 weeks

Also known as: Taxotere

Arm C: Docetaxel alone

EC20 DRUG

During the screening period participants will receive a single intravenous administration of EC20 prior to SPECT imaging

Also known as: Etarfolatide

Arm A: EC145 alone; Arm B: EC145 + Docetaxel; Arm C: Docetaxel alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to sign an approved informed consent form (ICF).
• Must be ≥ 18 years of age.
• Histology confirmed diagnosis of non-small cell lung cancer (adenocarcinoma, squamous, adenosquamous, or adenocarcinoma with other NSCLC variants of the lung) (Stage IIIB or IV).
• All (RECIST v1.1-defined) target lesions positive for the folate receptor \[FR(++)\] by SPECT scan.
• Only one prior systemic therapy for advanced disease (e.g.,a platinum doublet or a maintenance regimen that includes a platinum doublet; in addition, the participant may have received an epidermal growth factor receptor \[EGFR\] inhibitor).
• Radiological evaluation conducted no more than 28 days prior to beginning study therapy. If history of CNS metastasis baseline radiological imaging must include brain MRI or CT.
• Radiologic evidence of disease progression following the most recent prior treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Must have recovered (to baseline/stabilization) from prior cytotoxic-therapy-associated acute toxicities.
• Prior radiation therapy is allowed if the following criteria is met:
• Radiation to \< 25% of the bone marrow; whole pelvis radiation is excluded.
• Prior radiotherapy must be completed at least 2 weeks before randomization.
• Must have recovered from the acute toxic effects of the treatment before randomized.
• Prior thoracic radiation must be completed 30 days before study enrollment.
• Irradiated pulmonary lesions cannot be used as target or non-target lesions (and must be excluded) unless there is previous documented progression of these lesions.

You may not qualify if:

• Prior therapy with docetaxel, vinorelbine, or vinca-containing compounds.
• Known hypersensitivity to docetaxel or polysorbate 80.
• Symptomatic central nervous system (CNS) metastases or metastases that result in midline shift, significant edema.
• Malignancies other than NSCLC that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible.
• Serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension.
• Anti-folate therapy such as methotrexate for rheumatoid arthritis.
• Baseline peripheral neuropathy CTCAE ≥ Grade 2.
• Pregnant or lactating women.
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
• Active infections (e.g., hepatitis or HIV carriers)

Sponsors & Collaborators

• Endocyte: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Interventions

EC145; Docetaxel; technetium 99m etarfolatide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Binh Nguyen, MD, PhD

  Endocyte

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 16, 2012
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2015
• Last Updated: April 1, 2021

Record last verified: 2021-03