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

NCT01380769 | Completed Phase 2 Results

• 1 other identifier: CRLX-002
• Study Type: interventional
• Target: 157
• Locations: 2 countries
• Sites: 25

Brief 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).

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 18 months

Secondary Outcomes (1)

• Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only

  12 months

Study Arms (2)

CRLX101

EXPERIMENTAL

Drug: CRLX101

Best supportive care

OTHER

Other: Best Supportive Care

Interventions

CRLX101 DRUG

CRLX101 is administered at 15mg/m2 IV every other week

Also known as: NLG207

CRLX101

Best Supportive Care OTHER

best supportive care

Best supportive care

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NewLink Genetics Corporation: lead

Study Sites (25)

State Medical Institution Republican Oncology Center

Saransk, Respublika Mordoviya, 430032, Russia

Location

State Medical Institution Republic Clinical Oncological Center under the Healthcare Ministry of Tatarstan Republic

Kazan', Tatarstan Republic, 420029, Russia

Location

Arkhangelsk Regional Clinical Oncology Center

Arkhangelsk, 163045, Russia

Location

State Healthcare Institution: Bryansk Regional Oncology Center

Bryansk, 241033, Russia

Location

Chelyabinsk Regional Clinical Oncology Center

Chelyabinsk, 454087, Russia

Location

Kursk Regional Oncology Center

Kursk, 305035, Russia

Location

Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center

Moscow, 115478, Russia

Location

Non-Government Medical Institution: Central Clinical Hospital #2

Moscow, 129128, Russia

Location

State Healthcare Institution of Nizhny Novgorod Regiona Nizhny Novgorod Oncology Center

Nizhny Novgorod, 603081, Russia

Location

City Clinical Hospital #1

Novosibirsk, 630047, Russia

Location

State Medical Institution: Pyatigorsk Oncological Center

Pyatigorsk, 357500, Russia

Location

St. Petersburg Medical University

Saint Petersburg, 197022, Russia

Location

City Clinical Oncology Center

Saint Petersburg, 198255, Russia

Location

Stavropol Regional Clinical Oncology Center

Stavropol, 355047, Russia

Location

Tambov Regional Oncology Center

Tambov, 392013, Russia

Location

Primorsky Regional Oncology Center

Vladivostok, 690105, Russia

Location

Regional Clinical Oncology Center

Yaroslavl, 150054, Russia

Location

Dnipropetrovsk State Medical Academy

Dnipropetrovsk, 49102, Ukraine

Location

Public Treatment and Prophylaxis Institution; Donetsk Regional Antitumor Center

Donetsk, 83092, Ukraine

Location

Ivano-Frankovsk State Medical University; Oncology Department Clinical Facility

Ivano-Frankivsk, 76000, Ukraine

Location

Kharkiv State Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center

Kharkiv, 61070, Ukraine

Location

Khmelnytskyi Regional Oncology Center

Khmelnytsky, 29009, Ukraine

Location

Kyiv City Oncology Hospital

Kyiv, 03115, Ukraine

Location

Sumy Regional Clinical Oncology Center

Sumy, 40005, Ukraine

Location

Zakarpattia Regional Clinical Oncology Center

Uzhhorod, 88011, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

IT-101

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Adrian Senderowicz
• Organization: Cerulean Pharma Inc.

asenderowicz@ceruleanrx.com

617 551 9600

Study Officials

• NewLink Genetics

  NewLink Genetics Inc

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 22, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: October 1, 2014
• Last Updated: May 28, 2020
• Results First Posted: May 24, 2017

Record last verified: 2020-05

Locations

UA (8); RU (17)