A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer

May 26, 2020 updated by: NewLink Genetics Corporation

A Randomized, Phase 2, Study to Assess the Safety and Activity of CRLX101, a Nanoparticle Formulation of Camptothecin, in Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed One or Two Previous Regimens of Chemotherapy

The purpose of this study is to compare median overall survival of patients with advanced non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best supportive care (BSC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lung cancer remains the leading cause of cancer-related mortality in men and women worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer. The development of targeted therapies has changed the approach to treating NSCLC significantly over the past decade with targeted therapies generally possessing safety advantages over traditional cytotoxic regimens. However, combination paradigms and resistance patterns complicate the use of these agents. CRLX101 is a nanoparticle comprised of camptothecin (CPT) conjugated to a cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Arkhangelsk Regional Clinical Oncology Center
      • Bryansk, Russian Federation, 241033
        • State Healthcare Institution: Bryansk Regional Oncology Center
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Clinical Oncology Center
      • Kursk, Russian Federation, 305035
        • Kursk Regional Oncology Center
      • Moscow, Russian Federation, 115478
        • Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center
      • Moscow, Russian Federation, 129128
        • Non-Government Medical Institution: Central Clinical Hospital #2
      • Nizhny Novgorod, Russian Federation, 603081
        • State Healthcare Institution of Nizhny Novgorod Regiona Nizhny Novgorod Oncology Center
      • Novosibirsk, Russian Federation, 630047
        • City Clinical Hospital #1
      • Pyatigorsk, Russian Federation, 357500
        • State Medical Institution: Pyatigorsk Oncological Center
      • St. Petersburg, Russian Federation, 197022
        • St. Petersburg Medical University
      • St. Petersburg, Russian Federation, 198255
        • City Clinical Oncology Center
      • Stavropol, Russian Federation, 355047
        • Stavropol Regional Clinical Oncology Center
      • Tambov, Russian Federation, 392013
        • Tambov Regional Oncology Center
      • Vladivostok, Russian Federation, 690105
        • Primorsky Regional Oncology Center
      • Yaroslavl, Russian Federation, 150054
        • Regional Clinical Oncology Center
    • Republic Of Mordovia
      • Saransk, Republic Of Mordovia, Russian Federation, 430032
        • State Medical Institution Republican Oncology Center
    • Republic Of Tatarstan
      • Kazan, Republic Of Tatarstan, Russian Federation, 420029
        • State Medical Institution Republic Clinical Oncological Center under the Healthcare Ministry of Tatarstan Republic
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Dnipropetrovsk State Medical Academy
      • Donetsk, Ukraine, 83092
        • Public Treatment and Prophylaxis Institution; Donetsk Regional Antitumor Center
      • Ivano-Frankivsk, Ukraine, 76000
        • Ivano-Frankovsk State Medical University; Oncology Department Clinical Facility
      • Kharkiv, Ukraine, 61070
        • Kharkiv State Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center
      • Khmelnytsky, Ukraine, 29009
        • Khmelnytskyi Regional Oncology Center
      • Kyiv, Ukraine, 03115
        • Kyiv City Oncology Hospital
      • Sumy, Ukraine, 40005
        • Sumy Regional Clinical Oncology Center
      • Uzhgorod, Ukraine, 88011
        • Zakarpattia Regional Clinical Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients who are ≥ 18-years of age.
  • Histologically or cytologically confirmed, locally advanced or metastatic NSCLC (adenocarcinoma, bronchoalveolar, squamous cell, large cell, or mixed carcinoma) that is not amendable to surgical treatment and patient has have failed 1 or 2 different lines of chemotherapy.
  • Measureable disease and evidence of progression on the previous therapy. Progression may be clinical or radiological.
  • ECOG performance status of 0 or 1.
  • Life expectancy of at least 3 months.
  • Hemoglobin ≥ 10 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1500 cells/µL without growth factor support.
  • Platelet count ≥ 100,000 cells/µL without support.
  • Adequate hepatic and renal function including the following: Total bilirubin < 2 × ULN, AST or ALT ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastasis, PTT within normal limits, INR ≤ 1.5, Serum Creatinine <1.5 ULN
  • At least 4 weeks post any radiotherapy or biological therapy; at least 6 weeks post nitrosoureas therapy.
  • Full recovery from diagnostic or therapeutic surgery (i.e., complete wound healing) and at least 30 days have elapsed prior to initial dosing.
  • Full recovery from the toxic effects of prior therapy (i.e., Common Toxicity Criteria [CTC] Grade 1 or less with the exception of Grade 2 alopecia).
  • Women of childbearing potential must have adequate pregnancy test. If postmenopausal, must be ≥ 12 months since last menses.
  • Women of childbearing potential and men must agree to use an effective form of contraception during the study and for 60 days after the last dose of study drug.

Exclusion Criteria:

  • CNS metastases by radiologic evidence or histology, unless clinically stable (must have been treated by resection or radiation) for at least 4 weeks prior to first dose of study drug. Patients may not be receiving dexamethasone for control of CSF pressure.
  • Concurrent therapeutic anticoagulation: PTT less than or equal to 1.5 × ULN or low dose aspirin and low-weight heparin only are allowed.
  • More than 2 previous lines of chemotherapy for lung cancer. This includes biologic (immunotherapy) therapy.
  • History of previous cerebrovascular accident (CVA) or history transient ischemic attack (TIA) within 6 months of study entry.
  • History of prior malignancy not cured by excision. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least 2-year disease free interval.
  • Recent history (within 6 months of screening) of unstable angina, myocardial infarction, or NYHA Class III or IV congestive heart failure
  • History of cardiac arrhythmia requiring medical or electrical therapy.
  • QTc > 450 msec for males and > 470 msec for females.
  • Any major surgery within 30 days or minor surgery within 10 days of study entry, or patient not recovered from surgery.
  • History of organ or bone marrow transplant.
  • Known active and/or uncontrolled infection, including HIV and are not stable on antiretroviral therapy.
  • Any investigational therapy within 28 days of study entry.
  • Pregnant or nursing.
  • Anyone who in the judgment of the investigator cannot comply with the protocol, provide truly informed consent, or is likely to live < 90 days
  • Severe or significant allergy to any chemotherapy or premedication.
  • Clinically evident ascites (e.g., abdominal distention, bulging and/or fluid wave) or Grade 3 peripheral edema.
  • Any prior cancer treatment with a topoisomerase I inhibitor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CRLX101
Drug: CRLX101
CRLX101 is administered at 15mg/m2 IV every other week
Other Names:
  • NLG207
OTHER: Best supportive care
Other: Best Supportive Care
best supportive care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only
Time Frame: Up to 18 months
Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.
Up to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only
Time Frame: 12 months
Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NewLink Genetics Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: NewLink Genetics, NewLink Genetics Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRLX-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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