NSCLC Stage IVPhase 2Ipat-LungNCT04467801
Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy
A Phase 2 study testing Ipatasertib in people with NSCLC Stage IV and NSCLC Stage IIIB, run by Jun Zhang, MD, PhD at 5 sites in United States.
Trial summary
For metastatic/advanced NSCLC patients who do not have targetable mutations, either immunotherapy targeting the programmed death-1 and its ligand (PD-1/L1) pathway alone or in combination with platinum doublet chemotherapy is now a standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV, NSCLC Stage IIIB
- What is being tested?
- Ipatasertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Sep 2021to Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Life expectancy ≥12 weeks
- Males and females age ≥ 18 years
- Allowable type and amount of prior therapy:
- First line anti-Programmed death receptor and ligand (PD1/PD-L1), either single agent or in combination with chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
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- Measurable disease per RECIST version 1.1
- Diagnoses of advanced/metastatic NSCLC and have failed or are intolerant to 1st line anti-PD1/PD-L1, either single agent or in combination with chemotherapy, and have either exhausted or decline or not be candidates for all available standard of care therapies.
- Adequate organ function
- Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use an acceptable form of contraception for the duration of study participation, and for 90 days following completion of therapy
- Men of child-bearing potential must agree not to donate sperm while on this study and for 90 days after their last study treatment
Who cannot join
- Is not concurrent enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or if the participant is in the follow-up period of an interventional study
- Is not currently on or is not anticipated to use other investigational agents within 14 days prior to and while participating in this study
- Does not have mixed small cell and non-small cell lung cancer histology
- Does not have any unresolved toxicity CTCAE >Grade 2 from the prior 1st immunotherapy. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study drug may be included
- Patients who have targetable mutations that qualify for targeted therapy (e.g. mutations of epidermal growth factor receptor (EGFR), serine/ threonine- protein kinase (BRAF), anaplastic lymphoma kinase (ALK), tyrosine- protein kinase (ROS1), neurotrophic receptor tyrosine kinase (NTRAK)) will be excluded from this study
- Is not on concomitant therapy intended for the treatment of cancer (including, but not limited to, chemotherapy, hormonal therapy, immunotherapy, radiotherapy, and herbal therapy) for 14 days prior to starting study treatment, depending on the agent and during study treatment, until disease progression is documented and the patient has discontinued study treatment, with the exception of palliative radiotherapy and local therapy per PI discretion
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- Does not chronically use a strong cytochrome P4503A4 (CYP3A4/5) inhibitor or inducer, or sensitive CYP3A substrates with a narrow therapeutic window
- Has not had recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of study drug
- Does not have uncontrolled systemic disease
- Does not have uncontrolled brain metastasis
- Does not have history of allergy to taxanes
- Does not have history of leptomeningeal carcinomatosis
- Does not have recent history of myocardial infarction (MI) or symptomatic coronary artery disease within 6 months of screening
- Is not receiving active therapy for HIV, hepatitis B or hepatitis C
- Does not have history of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills
- Does not have history of Type I or Type II diabetes mellitus requiring insulin (Patients who are on a stable dose of oral diabetes medication greater than or equal to 2 weeks prior to initiation of study treatment
- Does not have Grade greater than or equal to 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
- Does not have history of or active inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis)
- Does not have active pneumonitis
- Does not have history of lung disease: interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections
- Does not have uncontrolled pleural effusion/pericardial effusion/or ascites as determined by the investigator
- Does not have active ventricular arrhythmia requiring medication
- Does not have psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent
- Is not pregnant, breast feeding or planning to become pregnant while receiving study treatment or for less than 90 days after the last dose of study treatment
- For males with partners of childbearing potential, is not planning to father a child or donate sperm while receiving study treatment or for less than 90 days after the last dose of study treatment
- Does not have any condition that, in the opinion of the investigator, would interfere with evaluation or interpretation of patient safety or study results
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 2 recruiting
- Recruiting
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, 66205
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
Steve Williamson, MD, 913-588-3808, SWILLIAM@kumc.edu
- Recruiting
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
- Active, not recruiting
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, 64154
- Active, not recruiting
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, 64064
- Active, not recruiting
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, 66210
About this study
Official title: A Multi-center Phase II Study of Ipatasertib in Combination With Docetaxel in Metastatic/Advanced NSCLC Patients Who Have Failed or Are Intolerant to 1st Line Immunotherapy (Ipat-Lung)
For metastatic/advanced NSCLC patients who do not have targetable mutations, either immunotherapy targeting the programmed death-1 and its ligand (PD-1/L1) pathway alone or in combination with platinum doublet chemotherapy is now a standard of care. However, still about half of the patients do not benefit due to treatment resistance. It is therefore critically important to find novel therapies and combinations to benefit patients who have failed or are intolerant to 1st line immunotherapy.
This study hypothesizes that ipatasertib in combination with taxane (e.g. docetaxel) can be an effective strategy. Ipatasertib is a novel adenosine triphosphate (ATP)-competitive inhibitor that has demonstrated robust and selective targeting of protein kinase B (PKB, also known as AKT) in cancer patients. Importantly, evidence from preclinical studies has demonstrated that AKT inhibitors (e.g. ipatasertib) can enhance the therapeutic effect of chemotherapy as well as immunotherapy via modulating Phosphatidylinositol 3-kinase (PI3'K)-AKT activity.
- Conditions
- NSCLC Stage IV, NSCLC Stage IIIB
- Being tested
- Ipatasertib
- Keywords
- Advanced/metastatic NSCLC
- 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.
IpatasertibDrug
Ipatasertib is a novel ATP-competitive inhibitor. It is taken by mouth once daily.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Ipatasertib, 400 mg once daily, Oral, Days 1-14 of each 21 day cycle (2 weeks on and 1 week off).
Docetaxel, 75 mg/m2, Intra-venous, Day 1 of each 21 day cycle. Receives: Drug: Ipatasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
RECIST 1.1
Measured: up to 12 months
Secondary outcomes (3)
Number of adverse events experienced by participants receiving treatment with ipatasertib in combination with docetaxel
CTCAE Version 5.0
Measured: At cycle 1day 8 (each cycle is 21 days) up to 2 months (60 days) after End of treatment
Overall Response Rate
RECIST 1.1
Measured: every 6 weeks up to 12 months
Overall Survival
Medical record
Measured: Cycle 1day 1 (each cycle is 21 days) to up to 12 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start14 Sep 2021
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Zhang, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of Kentucky
- Responsible party
- Sponsor-investigator, Jun Zhang, MD, PhD, University of Kansas Medical Center
- Investigators
- Jun Zhang, MD, PhD, Principal investigator, The University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467801
- Sponsor's protocol ID
- IIT-2019-IpatTax
- Acronym
- Ipat-Lung
- Status last verified
- Nov 2023
- First submitted
- 15 Jun 2020
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase II Study of Ipatasertib in Combination With Docetaxel in Metastatic/Advanced NSCLC Patients Who Have Failed or Are Intolerant to 1st Line Immunotherapy (Ipat-Lung)
- ClinicalTrials.gov ID
- NCT04467801
- Acronym / sponsor ID
- Ipat-Lung / IIT-2019-IpatTax
- Conditions
- NSCLC Stage IV, NSCLC Stage IIIB
- Keywords
- Advanced/metastatic NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jun Zhang, MD, PhDUniversity, hospital or other
- Collaborators
- University of Iowa, University of Kentucky
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For metastatic/advanced NSCLC patients who do not have targetable mutations, either immunotherapy targeting the programmed death-1 and its ligand (PD-1/L1) pathway alone or in combination with platinum doublet chemotherapy is now a standard of care. However, still about half of the patients do not benefit due to treatment resistance. It is therefore critically important to find novel therapies and combinations to benefit patients who have failed or are intolerant to 1st line immunotherapy.
This study hypothesizes that ipatasertib in combination with taxane (e.g. docetaxel) can be an effective strategy. Ipatasertib is a novel adenosine triphosphate (ATP)-competitive inhibitor that has demonstrated robust and selective targeting of protein kinase B (PKB, also known as AKT) in cancer patients. Importantly, evidence from preclinical studies has demonstrated that AKT inhibitors (e.g. ipatasertib) can enhance the therapeutic effect of chemotherapy as well as immunotherapy via modulating Phosphatidylinositol 3-kinase (PI3'K)-AKT activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: IpatasertibIpatasertib, 400 mg once daily, Oral, Days 1-14 of each 21 day cycle (2 weeks on and 1 week off). Docetaxel, 75 mg/m2, Intra-venous, Day 1 of each 21 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Life expectancy ≥12 weeks
- Males and females age ≥ 18 years
- Allowable type and amount of prior therapy:
- First line anti-Programmed death receptor and ligand (PD1/PD-L1), either single agent or in combination with chemotherapy
Key exclusion criteria (26 listed)
- Is not concurrent enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or if the participant is in the follow-up period of an interventional study
- Is not currently on or is not anticipated to use other investigational agents within 14 days prior to and while participating in this study
- Does not have mixed small cell and non-small cell lung cancer histology
- Does not have any unresolved toxicity CTCAE >Grade 2 from the prior 1st immunotherapy. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study drug may be included
- Patients who have targetable mutations that qualify for targeted therapy (e.g. mutations of epidermal growth factor receptor (EGFR), serine/ threonine- protein kinase (BRAF), anaplastic lymphoma kinase (ALK), tyrosine- protein kinase (ROS1), neurotrophic receptor tyrosine kinase (NTRAK)) will be excluded from this study
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 |
|---|---|---|
| IpatasertibIpatasertib is a novel ATP-competitive inhibitor. It is taken by mouth once daily. | Drug | Treatment |
Primary outcome
Progression Free Survival
Time frame: up to 12 months
RECIST 1.1
3 secondary outcomes
Number of adverse events experienced by participants receiving treatment with ipatasertib in combination with docetaxel
Time frame: At cycle 1day 8 (each cycle is 21 days) up to 2 months (60 days) after End of treatment
Overall Response Rate
Time frame: every 6 weeks up to 12 months
Overall Survival
Time frame: Cycle 1day 1 (each cycle is 21 days) to up to 12 months after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- 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.
Jun Zhang, MD, PhD principal investigator
The University of Kansas
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipatasertib in people with NSCLC Stage IV and NSCLC Stage IIIB, run by Jun Zhang, MD, PhD at 5 sites 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 11 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KUCC Navigator (9135883671, KUCC_Navigation@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: up to 12 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 7 Nov 2023.