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Phase 2 Study of Etirinotecan Pegol (NKTR-102) in the Treatment of Patients With Metastatic and Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of 2nd Line Treatment

Phase 2
Open (Enrolling)
Metastatic Non Small Cell Lung Cancer, Recurrent Non Small Cell Lung Cancer

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Trial Information

Phase 2 Study of Etirinotecan Pegol (NKTR-102) in the Treatment of Patients With Metastatic and Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of 2nd Line Treatment

This is a Phase 2 study designed to characterize the objective response rate (defined as
complete response (CR) and partial response (PR)) of Etirinotecan pegol (NKTR-102)
administered to subjects with metastatic and recurrent NSCLC after failure of 2nd line
therapy. Up to 37 eligible subjects will be enrolled at the University of Pennsylvania.

One cycle will be defined as 3 weeks. Patients will be followed clinically every week for
the first cycle with laboratory parameters and physical exam. Response will be determined by
RECIST version1.1 after 2 cycles of therapy. Patients with stable disease (SD), PR or CR
will continue on treatment for up to six cycles. Those who are benefitting after six cycles
will have the option of continuing on treatment. Patients with progressive disease will be
taken off study and will be followed for OS data.

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic or recurrent NSCLC. Primary or
metastatic site may be used for histology.

- After failure of 2nd line treatment with up to two prior lines of therapy, one of
which may be an oral TKI.

- Measurable disease (Tumors within a previously irradiated field will be designated as
"nontarget" lesions unless progression is documented incontrovertibly either
radiographically or pathologically. For clinicians relying on biopsy documentation
of recurrence, this must be obtained to confirm persistence at least 90 days
following completion of radiation therapy).

- Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.

- Age at the time of study entry is ≥ 18 years.

- Adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥
1500/μL, hemoglobin ≥ 9.0 g/dL, and a platelet count ≥ 100,000/μL obtained within 2
weeks prior to enrollment.

- Adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate
transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 × the upper limit of normal
([ULN]), or ≤ 5 × the ULN in the presence of known liver metastases.

- Alkaline phosphatase (AP) ≤ 3 x the ULN or ≤ 5 × the ULN in the presence of known
liver metastases

- Adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN.
If creatinine is above the ULN, the patient's measured or calculated creatinine
clearance (CrCl) must be ≥ 50 mL/min.

- Resolution of chemotherapy and radiation therapy related toxicities to NCI-CTCAE
version 4.0 Grade 1 or lower severity, except for diarrhea (which must be Grade 0
without a supportive antidiarrheal medications) and alopecia (any grade).

- Women of childbearing potential and sexually active males must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
enrollment and for the duration of study participation. Protections against pregnancy
must be continued for at least 8 months after the last dose of study drug.

- Signed informed consent.

Exclusion Criteria:

- Untreated central nervous system metastases. Patients are eligible if they are
clinically stable, off all steroids after cranial irradiation (whole brain radiation
therapy, focal radiation therapy, stereotactic radio surgery) ending at least 2 weeks
prior to enrollment, or after surgical resection performed at least 2 weeks prior to

- History of another "active" invasive primary cancer requiring ongoing treatment.

- Concurrent treatment with other anticancer therapy, including other chemotherapy,
immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy,
or an investigational agent.

- Patients who have had chemotherapy within 21 days (42 days for nitrosoureas or
mitomycin C), radiotherapy within 14 days, biological therapy within 14 days,
hormonal therapy within 7 days, and investigational therapy within 21 days prior to

- Patients who have had any major surgery within 21 days prior to enrollment.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection requiring parenteral antibiotics, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.

- Patients with chronic or acute GI disorders resulting in diarrhea of any severity
grade; patients who are using chronic anti-diarrheal supportive care (more than 3
days/week) to control diarrhea in the 28 days prior to enrolment.

- Administration of the CYP3A4 inducers or inhibitors, as they may induce or inhibit
irinotecan or SN38 metabolism within 14 days prior to cycle 1 and throught study
treatment. For a list of these agents, see:

- Uncontrolled thrombotic or hemorrhagic disorder.

- Known human immunodeficiency virus (HIV) positivity.

- The patient, if female, is pregnant or lactating.

- Previous therapy with a topoisomerase I or II inhibitor.

- Known allergy to any of the treatment components.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Outcome Time Frame:

up to 18 weeks

Safety Issue:


Principal Investigator

Charu Aggarwal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Food and Drug Administration

Study ID:

UPCC 18512



Start Date:

January 2013

Completion Date:

January 2016

Related Keywords:

  • Metastatic Non Small Cell Lung Cancer
  • Recurrent Non Small Cell Lung Cancer
  • Male and female subjects 18 years of age and older
  • metastatic or recurrent NSCLC
  • who have failed 2nd line therapy (with up to two prior cytotoxic regimens and one prior exposure to an oral TKI).
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283