Non-Small Cell Lung CancerPhase 2NCT01380769
A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing CRLX101 in people with Non-Small Cell Lung Cancer, run by NewLink Genetics Corporation at 25 sites in 2 countries.
Trial summary
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). 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?
- CRLX101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Jun 2011to Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
Russia17 sites
Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk, 163045
State Healthcare Institution: Bryansk Regional Oncology Center
Bryansk, 241033
Chelyabinsk Regional Clinical Oncology Center
Chelyabinsk, 454087
State Medical Institution Republic Clinical Oncological Center under the Healthcare Ministry of Tatarstan Republic
Kazan', Tatarstan Republic, 420029
Kursk Regional Oncology Center
Kursk, 305035
Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center
Moscow, 115478
Non-Government Medical Institution: Central Clinical Hospital #2
Moscow, 129128
State Healthcare Institution of Nizhny Novgorod Regiona Nizhny Novgorod Oncology Center
Nizhny Novgorod, 603081
City Clinical Hospital #1
Novosibirsk, 630047
State Medical Institution: Pyatigorsk Oncological Center
Pyatigorsk, 357500
St. Petersburg Medical University
Saint Petersburg, 197022
City Clinical Oncology Center
Saint Petersburg, 198255
State Medical Institution Republican Oncology Center
Saransk, Respublika Mordoviya, 430032
Stavropol Regional Clinical Oncology Center
Stavropol, 355047
Tambov Regional Oncology Center
Tambov, 392013
Primorsky Regional Oncology Center
Vladivostok, 690105
Regional Clinical Oncology Center
Yaroslavl, 150054
Ukraine8 sites
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, 49102
Public Treatment and Prophylaxis Institution; Donetsk Regional Antitumor Center
Donetsk, 83092
Ivano-Frankovsk State Medical University; Oncology Department Clinical Facility
Ivano-Frankivsk, 76000
Kharkiv State Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center
Kharkiv, 61070
Khmelnytskyi Regional Oncology Center
Khmelnytsky, 29009
Kyiv City Oncology Hospital
Kyiv, 03115
Sumy Regional Clinical Oncology Center
Sumy, 40005
Zakarpattia Regional Clinical Oncology Center
Uzhhorod, 88011
About this study
Official title: 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).
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- CRLX101, Best Supportive Care
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRLX101Drug
Also called NLG207
CRLX101 is administered at 15mg/m2 IV every other week
Best Supportive CareOther
best supportive care
| Study group | Role | What they receive |
|---|---|---|
| CRLX101 | Experimental | Not described Receives: Drug: CRLX101 |
| Best supportive care | Other | Not described Receives: Other: Best Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only
Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.
Measured: Up to 18 months
Secondary outcomes (1)
Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only
Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewLink Genetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- NewLink Genetics, Study chair, NewLink Genetics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380769
- Sponsor's protocol ID
- CRLX-002
- Status last verified
- May 2020
- First submitted
- 22 Jun 2011
- Last updated
- 28 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01380769
- Acronym / sponsor ID
- CRLX-002
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- NewLink Genetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 24 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRLX101 | Experimental | Drug: CRLX101 |
| Best supportive care | Other | Other: Best Supportive Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRLX101Also: NLG207CRLX101 is administered at 15mg/m2 IV every other week | Drug | CRLX101 |
| Best Supportive Carebest supportive care | Other | Best supportive care |
Primary outcome
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.
1 secondary outcome
Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NewLink Genetics study chair
NewLink Genetics Inc
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRLX101 in people with Non-Small Cell Lung Cancer, run by NewLink Genetics Corporation at 25 sites in 2 countries.
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 14 inclusion and 17 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 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Russia, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2020.