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Non Small Cell Lung CancerPhase 2TARGETNCT01577654

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

A Phase 2 study testing EC145, EC145 + Docetaxel and Docetaxel in people with Non Small Cell Lung Cancer, run by Endocyte.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
EC145, EC145 + Docetaxel and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
No sites listed yet
Study dates
Mar 2011to Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Palliative extrathoracic radiotherapy can continue, but these lesions must be excluded as target and non-target lesions.
  • Adequate organ function:
  • Bone marrow reserve: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelets ≥ 100 x 109/L. Hemoglobin ≥ 9 g/dL.
  • Hepatic: Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) and alkaline phosphatase ≤ 2.5 x ULN.
  • Renal: Serum creatinine ≤ 1.5 x ULN, or for participants with serum creatinine > 1.5 ULN, creatinine clearance ≥ 50 mL/min/1.73 m2 (50mL/min/1.73m2 is equivalent to 0.83 mL/s/m2).
  • Participants of childbearing potential:
  • Women who are capable of becoming pregnant must have a negative serum pregnancy test within 1 week prior to exposure to EC20 and within 1 week prior to exposure to treatment with EC145 and/or docetaxel.
  • Women who are capable of becoming pregnant and male participants who are sexually active must practice an effective method of birth control for the duration of their participation in the trial through 3 months following the last dose of EC145 and through 6 months following the last dose of docetaxel.

Who cannot join

  • 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.
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  • 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)

About this study

Official title: A Randomized, Open-label Phase 2 Study of EC145 Single-agent and the Combination of EC145 Plus Docetaxel Versus Docetaxel Alone in Participants With Folate-receptor Positive [FR(++)] Second Line NSCLC

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(++)].

Read the detailed description

In a phase 2 study of single-agent EC145 in heavily pretreated non-small cell lung cancer (NSCLC) patients (median of 3 prior chemotherapy regimens), the subgroup with all target lesions expressing the folate receptor [FR(++)] had a promising prolonged progression free survival of 7.1 months and overall survival of 10.9 months. Furthermore, in-vitro and in-vivo studies in KB models showed good synergism between EC145 and docetaxel.

This study will clinically assess for the first time the combination of EC145+docetaxel (Arm B) in participants with NSCLC (Stage IIIB or IV). This is an international, multicenter, centrally randomized, open-label, phase 2 study comparing single-agent EC145, EC145+docetaxel combination therapy, and single-agent docetaxel in participants with NSCLC who have failed one prior chemotherapy and who have all target lesions expressing the folate receptor [FR(++)]. Eligible participants will be randomized in a 1:1:1 ratio into either Arm A (single-agent EC145), Arm B (EC145+docetaxel combination therapy), or Arm C (single-agent docetaxel) and will receive treatment until either disease progression or intolerable toxicity.

This study is intended to investigate if there is a sufficiently strong efficacy signal in order to proceed with phase 3 testing with either EC145 single-agent and/or the combination of EC145+docetaxel against the standard-of-care docetaxel in second-line NSCLC.

This study will clinically assess for the first time the combination of EC145+docetaxel (Arm B) in participants with NSCLC (Stage IIIB or IV). Therefore, an interim safety analysis will be done by the DSMB after 5 participants in Arm B have completed 1 cycle of therapy, and the second analysis after 15 participants in Arm B have completed 1 cycle of therapy.

If the majority of the enrolled participants (more than 70%) require a dose reduction of one level (to 60 mg/m2), the dose will be reduced for the remainder of the study. If the majority of the participants (more than 70%) require 2 dose reductions (to 40 mg/m2), the sponsor will consider discontinuing the combination arm.

Being tested
EC145, EC145 + Docetaxel, Docetaxel, EC20
Keywords
adenocarcinoma, squamous, adenosquamous, adenocarcinoma with other NSCLC variants, EC145, EC20, Vintafolide, Etarfolatide
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EC145Drug

    Also called Vintafolide

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

  • EC145 + DocetaxelDrug

    Also called Vintafolide, Taxotere

    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

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 IV Day 1 q 3 weeks

  • EC20Drug

    Also called Etarfolatide

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

Study groups in NCT01577654
Study groupRoleWhat they receive
Arm A: EC145 aloneExperimentalEC145 alone
Receives: Drug: EC145; Drug: EC20
Arm B: EC145 + DocetaxelExperimentalEC145 + Docetaxel
Receives: Drug: EC145 + Docetaxel; Drug: EC20
Arm C: Docetaxel aloneActive comparatorDocetaxel alone
Receives: Drug: Docetaxel; Drug: EC20

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Compare overall response rate of participants between treatment arms.

    Analysis will occur when approximately 50% of the PFS events have occurred (for each comparison) and when 94 PFS events have occurred.

    Measured: up to 26 months

  2. Compare disease control rate of participants between treatment arms.

    Analysis will occur when approximately 50% of the PFS events have occurred (for each comparison) and when 94 PFS events have occurred.

    Measured: up to 26 months

  3. Compare duration of response of participants between treatment arms.

    Analysis will occur when approximately 50% of the PFS events gave occurred (for each comparison) and when 94 PFS events have occurred.

    Measured: up to 26 months

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

    Analysis will occur when approximately 50% of the PFS events gave occurred (for each comparison) and when 94 PFS events have occurred.

    Measured: up to 26 months

  5. Compare overall survival of participants between treatment arms.

    Analysis will occur when approximately 50% of the PFS events gave occurred (for each comparison) and when 94 PFS events have occurred.

    Measured: up to 26 months

  6. Incidence of Adverse Events, Serious Adverse Events, and Deaths.

    Adverse events (as a measure of safety and tolerability) will be assessed at each study visit.

    Measured: up to 26 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2012 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2013
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01577654
Sponsor's protocol ID
8109-003
Other IDs
2012-000966-40
Acronym
TARGET
Status last verified
Mar 2021
First submitted
11 Apr 2012
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EC145, EC145 + Docetaxel and Docetaxel in people with Non Small Cell Lung Cancer, run by Endocyte.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival(PFS)based on investigator assessment using RECIST v1.1 (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01577654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

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