Stage IV Non-small Cell Lung Cancer (NSCLC)Phase 2NCT02312622
Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer
A Phase 2 study testing Pegylated Irinotecan in people with Stage IV Non-small Cell Lung Cancer (NSCLC) and Recurrent Non-small Cell Lung Cancer (NSCLC), run by Joel Neal at 1 site in United States.
Trial summary
This phase 2 trial evaluates how well pegylated irinotecan (NKTR-102) works in treating patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or breast cancer (mBC) that has spread to the brain and does not respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer (NSCLC), Recurrent Non-small Cell Lung Cancer (NSCLC), Extensive-stage Small Cell Lung Cancer (SCLC)
- What is being tested?
- Pegylated Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2019
- 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
- At least 18 years of age.
- Life expectancy of 3 months or longer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Advanced or refractory cancer, consisting of
- Metastatic breast cancer (mBC) for which single-agent cytotoxic chemotherapy is indicated. OR
- Histologically-proven metastatic lung cancer:
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- Non-small cell lung cancer (NSCLC) as Stage IV disease or recurrent metastatic disease [per lung cancer tumor, node and metastasis (TNM) classification system, 7th ed] (Cohort A) OR
- Small cell lung cancer (SCLC) as extensive stage or recurrent metastatic disease (cohort B), including tumors with mixed small cell and non-small cell elements.
- Prior chemotherapy (at least one of the following):
- At least one line of prior systemic chemotherapy
- At least one line of prior targeted treatment for metastatic disease Adjuvant systemic chemotherapy within prior 6 months Prior treatment for metastatic breast cancer (mBC) must have included taxane-based regimen
- Prior chemotherapy, including other investigational therapy, has been completed prior to initiation of study treatment, according to the following:
- ≥ 2 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered on a daily or weekly schedule
- ≥ 3 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 2 weeks
- ≥ 4 weeks if immediately preceding treatment was chemotherapy/targeted therapy administered every 3 weeks Previously received at least one CNS directed treatment (such as surgery or radiation) OR not be eligible for CNS stereotactic radiosurgery Measurable CNS disease, either previously untreated (not counting systemic therapy), or progressed following previous radiation treatment. Lesions that have progressed after prior radiosurgery should not be selected as measurable disease if they are suspected of being radionecrosis.
- The following measurement criteria are required, as visualized by contrast-enhanced MRI with slice thickness of ≤ 1.5 mm, unless absence of contrast or thicker slices is specifically authorized by Protocol Director. Measurements do not include tumor edema.
- At least one CNS tumor measuring ≥ 10 mm in longest diameter, OR
- At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring ≥ 3 mm in longest diameter, for which the sum of the longest diameters is ≥ 10 mm. Additional tumors are not exclusionary.
- Adequate organ function as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L without G-CSF (filgrastim, pegfilgrastim, or equivalent) support within 7 days
- Hemoglobin (Hgb) ≥ 9.0 g/dL (90 g/L) without blood transfusion within 7 days
- Platelet count ≥ 100 x 10e9/L without platelet transfusion within 7 days
- Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with documented history of Gilbert's disease who may have DIRECT bilirubin ≤ 1.5 X ULN
- Alanine aminotransferase (ALT) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases
- Aspartate aminotransferase (AST) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases
- Serum creatinine ≤ 1.5 X ULN; or calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula), or measured creatinine clearance ≥ 50 mL/min.
Who cannot join
- Previous treatment with a camptothecin derivative (eg, irinotecan, topotecan, and investigational agents including but not limited to exatecan, rubitecan, gimatecan, karenitecin, SN38 investigational agents, EZN 2208, SN 2310, and AR 67) is not allowed
- Patients may not have a known history of leptomeningeal disease, as diagnosed by positive CSF cytology, unless prospective permission for enrollment is granted from the sponsor and the PI
- Patients may not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period
- Patients may not have the following co morbid disease or concurrent illness:
- Chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients may not use chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to first dose of investigational drug. (exception: anti-diarrheal medications used to control symptoms from a medication that will be discontinued prior to study are allowed with a 7 day washout before study therapy, for example loperamide for erlotinib-associated diarrhea)
- Known cirrhosis, defined as Child Pugh class A or higher liver disease
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- Other active malignancy, except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder)
- Any other severe/uncontrolled inter current illness or significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation
- Patients may not have a known allergy or hypersensitivity to any of the components of the investigational therapy, including polyethylene glycol (PEG) or topoisomerase inhibitors
- Patients may not be receiving the following medications at the time of first dose of investigational drug:
- Pharmacotherapy for known hepatitis B or C, tuberculosis, or human immunodeficiency virus (HIV)
- Any of the following enzyme inducing anti epileptic medications (EIAEDs): phenytoin, carbamazepine, oxcarbazepine, phenobarbital
- Other chemotherapy, hormonal therapy, immunotherapy, other investigational agents, or biologic agents for the treatment of cancer except for bisphosphonates or denosumab
- Pregnant or nursing patients will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase 2 Study of Etirinotecan Pegol (NKTR-102) in Patients With Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)
This phase 2 trial evaluates how well pegylated irinotecan (NKTR-102) works in treating patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or breast cancer (mBC) that has spread to the brain and does not respond to treatment. Pegylated irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
Primary Objective:
For cohort A and Cohort C, to determine the central nervous system (CNS) disease control rate (number of patients with stable disease or partial response or complete response / total number of treated patients) at 12 weeks following treatment with etirinotecan pegol in patients with advanced non-small cell lung cancer (NSCLC) or with metastatic brain cancer (mBC) with refractory brain metastases
Secondary Objectives:
Cohorts A and C:
- To measure the overall disease control rate and response rate for patients receiving study therapy
- To measure the systemic (non-CNS) disease control rate and response rate for patients receiving study therapy
- To observe the progression free survival of the study population
- To observe the overall survival of the study population
Cohort B:
- To observe CNS and systemic disease control in small cell lung cancer (SCLC)
Cohorts A, B and C:
- To determine the safety profile of etirinotecan pegol
- Conditions
- Stage IV Non-small Cell Lung Cancer (NSCLC), Recurrent Non-small Cell Lung Cancer (NSCLC), Extensive-stage Small Cell Lung Cancer (SCLC), Recurrent Small Cell Lung Cancer (SCLC), Tumors Metastatic to Brain, Metastatic Breast Cancer (mBC)
- Being tested
- Pegylated Irinotecan
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Brain Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated IrinotecanDrug
Also called NKTR-102, PEG-irinotecan, etirinotecan pegol
Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Pegylated Irinotecan to treat NSCLC | Experimental | Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Pegylated Irinotecan |
| Cohort B - Pegylated Irinotecan to treat SCLC | Experimental | Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Pegylated Irinotecan |
| Cohort C - Pegylated Irinotecan to treat mBC | Experimental | Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Pegylated Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Nervous System (CNS) Disease Control Rate (Cohort A and C)
Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion.
Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
- CR = Disappearance of all target lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved
- PR = ≥ 30% decrease in target lesion LD and no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved
- PD (progressive disease) = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration
- SD = Neither PR or PD
Measured: At 12 weeks
Secondary outcomes (9)
Overall Disease Control Rate (Cohort A and C)
Overall disease control (DC) rate is defined as the sum in a cohort of the numbers of participants achieving complete response (CR); partial response (PR); or stable disease (SD), divided by the number of patients in that cohort. For this outcome, "overall" means all body systems, not just the central nervous system (CNS). The outcome is reported as DC rate, a number without dispersion.
Response criteria are as follows. Note that any lesion <10 mm in longest diameter (LD) is considered unchanged unless there is a ≥3 mm change in the sum of the LDs.
- CR = Disappearance of all target lesions, sustained for ≥4 weeks with no new lesions; clinical condition stable or improved
- PR = ≥30% decrease in target lesion LD \& no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved
- PD = Any of: 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration
- SD = Neither PR or PD
Measured: At 12 weeks
Overall Response Rate (Cohort A and C)
Overall response by subject (OR) is defined as the lower assessment between the central nervous system response and the systemic response. Response is defined as either complete response (CR) or partial response (PR). The outcome is reported as the number and percentage of participants who achieve OR, a number without dispersion.
Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
- CR = Disappearance of all lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved
- PR = ≥ 30% decrease in target lesion LD \& no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved
- PD = Any of: 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration
- SD = Neither PR or PD
Measured: At 12 weeks
Systemic (Non-CNS) Disease Control Rate (Cohort A and C)
Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion.
Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
- CR = Disappearance of all lesions, no new lesions; pathological lymph nodes reduced in short axis to < 10 mm
- PR = ≥ 30% decrease in sum of lesion diameters; no new lesions; no progression of non-target lesions
- PD = Any of 20% increase in sum of lesion diameters; progression of non-target lesions; new lesions
- SD = Neither CR, PR, nor PD
Measured: At 12 weeks
Systemic (Non-CNS) Response Rate (Cohort A and C)
Systemic (ie, non-central nervous system) response rate by cohort is defined as the number of participants achieving a complete response (CR) or partial response (PR), divided by the number of participants. The outcome will be reported as a number without dispersion.
Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
- CR = Disappearance of all target lesions, no new lesions; pathological lymph nodes reduced in short axis to < 10 mm
- PR = ≥ 30% decrease in sum of lesion diameters; no new lesions; no progression of non-target lesions
- PD = Any of 20% increase in sum of lesion diameters; progression of non-target lesions; new lesions
- SD = Neither CR, PR, nor PD
Measured: At 12 weeks
Progression-free Survival (PFS) (Cohort A and C)
Progression-free survival (PFS) is defined as the time from the date of start of treatment until disease progression or death. The outcome is reported by cohort as PFS in months, with full range.
Measured: Date of first dose of pegylated irinotecan NKTR 102 to date of disease progression, assessed up to 2 years
Overall Survival (Cohort A and C)
Overall survival (OS) is defined as the period remaining alive after the start of treatment. The outcome is reported as the median with full range.
Measured: 4 years
Central Nervous System (CNS) Disease Control (Cohort B)
Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion.
Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
- CR = Disappearance of all target lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved
- PR = ≥ 30% decrease in target lesion LD and no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved
- PD = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration
- SD = Neither PR or PD
Measured: At 12 weeks
Systemic Disease Control (Cohort B)
Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion.
Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.
- CR = Disappearance of all lesions, no new lesions; pathological lymph nodes reduced in short axis to < 10 mm
- PR = ≥ 30% decrease in sum of lesion diameters; no new lesions; no progression of non-target lesions
- PD = Any of 20% increase in sum of lesion diameters; progression of non-target lesions; new lesions
- SD = Neither CR, PR, nor PD
Measured: At 12 weeks
Related Adverse Events (Toxicity)
Toxicity, defined as related adverse events, is reported as the total number of events experienced by the participants in each cohort, a number without dispersion. Related is defined as meaning possibly, probably, or definitely related to the study drug.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startAug 2015
- Primary completion8 Sep 2018
- Study completionJul 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Non-small Cell Lung Cancer (NSCLC)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joel Neal
- Sponsor type
- University, hospital or other
- Collaborators
- Nektar Therapeutics
- Responsible party
- Sponsor-investigator, Joel Neal, Stanford University
- Investigators
- Joel Neal, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312622
- Sponsor's protocol ID
- IRB-30982
- Other IDs
- NCI-2014-02101, LUN0067, IRB-30982
- Status last verified
- Nov 2023
- First submitted
- 4 Dec 2014
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagpal S, Nguyen KS, Bertrand S, Cunanan KM, Padda SK, Pagtama JY, Tisch AH, Coffey G, Thomas RP, Sledge GW Jr, Gruber J, Telli ML, Pegram M, Recht LD, Wakelee HA, Soltys SG, Massarweh SA, Neal JW. Etirinotecan Pegol (NKTR-102) in Patients With Active Brain Metastases From Lung or Breast Cancer. Cancer Rep (Hoboken). 2025 Sep;8(9):e70330. doi: 10.1002/cnr2.70330.
PubMed 40877204
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Etirinotecan Pegol (NKTR-102) in Patients With Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT02312622
- Acronym / sponsor ID
- IRB-30982
- Conditions
- Stage IV Non-small Cell Lung Cancer (NSCLC), Recurrent Non-small Cell Lung Cancer (NSCLC), Extensive-stage Small Cell Lung Cancer (SCLC), Recurrent Small Cell Lung Cancer (SCLC), Tumors Metastatic to Brain, Metastatic Breast Cancer (mBC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Joel NealUniversity, hospital or other
- Collaborators
- Nektar Therapeutics
- Study start
- Aug 2015
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Posted 10 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2 trial evaluates how well pegylated irinotecan (NKTR-102) works in treating patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or breast cancer (mBC) that has spread to the brain and does not respond to treatment. Pegylated irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
Primary Objective:
For cohort A and Cohort C, to determine the central nervous system (CNS) disease control rate (number of patients with stable disease or partial response or complete response / total number of treated patients) at 12 weeks following treatment with etirinotecan pegol in patients with advanced non-small cell lung cancer (NSCLC) or with metastatic brain cancer (mBC) with refractory brain metastases
Secondary Objectives:
Cohorts A and C:
- To measure the overall disease control rate and response rate for patients receiving study therapy
- To measure the systemic (non-CNS) disease control rate and response rate for patients receiving study therapy
- To observe the progression free survival of the study population
- To observe the overall survival of the study population
Cohort B:
- To observe CNS and systemic disease control in small cell lung cancer (SCLC)
Cohorts A, B and C:
- To determine the safety profile of etirinotecan pegol
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Pegylated Irinotecan to treat NSCLC | Experimental | Drug: Pegylated IrinotecanPatients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. |
| Cohort B - Pegylated Irinotecan to treat SCLC | Experimental | Drug: Pegylated IrinotecanPatients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. |
| Cohort C - Pegylated Irinotecan to treat mBC | Experimental | Drug: Pegylated IrinotecanPatients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- At least 18 years of age.
- Life expectancy of 3 months or longer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Advanced or refractory cancer, consisting of
- Metastatic breast cancer (mBC) for which single-agent cytotoxic chemotherapy is indicated. OR
Key exclusion criteria (14 listed)
- Previous treatment with a camptothecin derivative (eg, irinotecan, topotecan, and investigational agents including but not limited to exatecan, rubitecan, gimatecan, karenitecin, SN38 investigational agents, EZN 2208, SN 2310, and AR 67) is not allowed
- Patients may not have a known history of leptomeningeal disease, as diagnosed by positive CSF cytology, unless prospective permission for enrollment is granted from the sponsor and the PI
- Patients may not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period
- Patients may not have the following co morbid disease or concurrent illness:
- Patients may not have a known allergy or hypersensitivity to any of the components of the investigational therapy, including polyethylene glycol (PEG) or topoisomerase inhibitors
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 |
|---|---|---|
| Pegylated IrinotecanAlso: NKTR-102, PEG-irinotecan, etirinotecan pegolAdministered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle) | Drug | Cohort A - Pegylated Irinotecan to treat NSCLC, Cohort B - Pegylated Irinotecan to treat SCLC, Cohort C - Pegylated Irinotecan to treat mBC |
Primary outcome
Central Nervous System (CNS) Disease Control Rate (Cohort A and C)
Time frame: At 12 weeks
Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion. Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs. * CR = Disappearance of all target lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved * PR = ≥ 30% decrease in target lesion LD and no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved * PD (progressive disease) = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration * SD = Neither PR or PD
9 secondary outcomes
Overall Disease Control Rate (Cohort A and C)
Time frame: At 12 weeks
Overall Response Rate (Cohort A and C)
Time frame: At 12 weeks
Systemic (Non-CNS) Disease Control Rate (Cohort A and C)
Time frame: At 12 weeks
Systemic (Non-CNS) Response Rate (Cohort A and C)
Time frame: At 12 weeks
Progression-free Survival (PFS) (Cohort A and C)
Time frame: Date of first dose of pegylated irinotecan NKTR 102 to date of disease progression, assessed up to 2 years
Overall Survival (Cohort A and C)
Time frame: 4 years
Central Nervous System (CNS) Disease Control (Cohort B)
Time frame: At 12 weeks
Systemic Disease Control (Cohort B)
Time frame: At 12 weeks
Related Adverse Events (Toxicity)
Time frame: Up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40877204Nagpal S, Nguyen KS, Bertrand S, Cunanan KM, Padda SK, Pagtama JY, Tisch AH, Coffey G, Thomas RP, Sledge GW Jr, Gruber J, Telli ML, Pegram M, Recht LD, Wakelee HA, Soltys SG, Massarweh SA, Neal JW. Etirinotecan Pegol (NKTR-102) in Patients With Active Brain Metastases From Lung or Breast Cancer. Cancer Rep (Hoboken). 2025 Sep;8(9):e70330. doi: 10.1002/cnr2.70330.
- Individual participant dataSharing planned: No
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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.
Joel Neal principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated Irinotecan in people with Stage IV Non-small Cell Lung Cancer (NSCLC) and Recurrent Non-small Cell Lung Cancer (NSCLC), run by Joel Neal at 1 site in United States.
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 26 inclusion and 14 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 10 Sep 2019). 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?
Central Nervous System (CNS) Disease Control Rate (Cohort A and C) (time frame: At 12 weeks). 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 NCT02312622, which also lists 1 linked publication.
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 12 Dec 2023.