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AKT Inhibitor
Ipatasertib + Docetaxel for Non-Small Cell Lung Cancer (Ipat-Lung Trial)
Phase 2
Recruiting
Research Sponsored by Jun Zhang, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men of child-bearing potential must agree not to donate sperm while on this study and for 90 days after their last study treatment
Life expectancy ≥12 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks up to 12 months
Awards & highlights
Ipat-Lung Trial Summary
This trial is for patients with NSCLC who have failed or are intolerant to 1st line immunotherapy. It is a combination of ipatasertib (a novel adenosine triphosphate [ATP]-competitive inhibitor) and taxane (e.g. docetaxel).
Who is the study for?
This trial is for adults over 18 with advanced/metastatic non-small cell lung cancer (NSCLC) who didn't respond to first-line anti-PD1/PD-L1 therapy. They should have a life expectancy of at least 12 weeks, be in good physical condition (ECOG 0 or 1), and not have any targetable mutations for other therapies. Participants must use contraception and cannot be pregnant, breastfeeding, or planning to donate sperm.Check my eligibility
What is being tested?
The study tests ipatasertib combined with docetaxel in patients whose NSCLC has progressed despite immunotherapy. Ipatasertib targets the AKT protein kinase which may enhance chemotherapy and immunotherapy effects by modulating PI3'K-AKT activity.See study design
What are the potential side effects?
Potential side effects include allergic reactions to taxanes like docetaxel, digestive issues due to bowel inflammation risks, heart problems including arrhythmias or recent heart attacks, difficulty swallowing pills due to malabsorption syndromes, uncontrolled diabetes affecting insulin levels.
Ipat-Lung Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to donate sperm during and for 3 months after the study.
Select...
My doctor expects me to live for at least 12 more weeks.
Select...
I am receiving my first treatment with PD1/PD-L1 inhibitors, alone or with chemotherapy.
Select...
My advanced lung cancer didn't respond or couldn't tolerate first-line immunotherapy.
Select...
I am fully active or can carry out light work.
Ipat-Lung Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Secondary outcome measures
Number of adverse events experienced by participants receiving treatment with ipatasertib in combination with docetaxel
Overall Response Rate
Overall Survival
Side effects data
From 2023 Phase 3 trial • 242 Patients • NCT0417710874%
Diarrhoea
40%
Nausea
35%
Neutropenia
35%
Neuropathy peripheral
35%
Anaemia
26%
Alanine aminotransferase increased
23%
Rash
23%
Alopecia
23%
Hyperglycaemia
21%
Asthenia
19%
Fatigue
16%
Vomiting
16%
Constipation
16%
Aspartate aminotransferase increased
14%
Pyrexia
14%
Mucosal inflammation
14%
Decreased appetite
12%
Blood creatinine increased
12%
Abdominal pain upper
12%
Blood alkaline phosphatase increased
12%
Myalgia
12%
White blood cell count decreased
12%
Paraesthesia
12%
Neutrophil count decreased
9%
Cough
9%
Dizziness
9%
Rhinorrhoea
9%
Weight decreased
9%
Urticaria
9%
Hypokalaemia
9%
Leukopenia
9%
Gamma-glutamyltransferase increased
9%
Insomnia
9%
Peripheral sensory neuropathy
9%
Arthralgia
7%
Urinary tract infection
7%
Hyperbilirubinaemia
7%
Lymphoedema
7%
Back pain
7%
Dyspepsia
7%
Hypomagnesaemia
7%
Stomatitis
7%
Lymphocyte count decreased
7%
Epistaxis
7%
Gastrooesophageal reflux disease
7%
Infusion related reaction
7%
Illness
7%
Pruritus
7%
Abdominal discomfort
5%
Septic shock
5%
Oedema peripheral
5%
Bone pain
5%
Blood glucose increased
5%
Hypothyroidism
5%
Cellulitis
5%
Erythema
5%
Dyspnoea
5%
Polyneuropathy
5%
Hyponatraemia
5%
Abdominal pain
5%
COVID-19
5%
Headache
5%
Lymphopenia
2%
Cholecystitis infective
2%
Hypersensitivity
2%
Dehydration
2%
Accidental overdose
2%
Blood cholesterol increased
2%
Pyelonephritis
2%
Neurotoxicity
2%
Blood albumin decreased
2%
Gastritis
2%
Glycosylated haemoglobin increased
2%
Hypernatraemia
2%
Blood lactate dehydrogenase increased
2%
Hyperkalaemia
2%
COVID-19 pneumonia
2%
Eczema
2%
Hypocalcaemia
2%
Upper gastrointestinal haemorrhage
2%
Clostridium difficile colitis
2%
Pleural effusion
2%
Drug eruption
2%
Musculoskeletal pain
2%
Lipase increased
2%
Acute kidney injury
2%
Rash maculo-papular
2%
Dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxe
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel
Ipat-Lung Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipatasertib
2011
Completed Phase 3
~2320
Find a Location
Who is running the clinical trial?
Jun Zhang, MD, PhDLead Sponsor
4 Previous Clinical Trials
155 Total Patients Enrolled
University of IowaOTHER
454 Previous Clinical Trials
881,978 Total Patients Enrolled
University of KentuckyOTHER
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226,089 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have or had inflammatory bowel disease or active bowel inflammation.You have a measurable disease according to specific guidelines.I agree not to donate sperm during and for 3 months after the study.I have severe side effects from my first immunotherapy.I, or my legal representative, can understand the study and agree to sign the consent form.My doctor expects me to live for at least 12 more weeks.I have high cholesterol or triglycerides that are not under control.My cancer has a mutation that can be treated with specific drugs.You have had an allergic reaction to taxanes in the past.I am receiving my first treatment with PD1/PD-L1 inhibitors, alone or with chemotherapy.My advanced lung cancer didn't respond or couldn't tolerate first-line immunotherapy.I haven't had cancer treatment in the last 14 days, except possibly for palliative care.I am fully active or can carry out light work.I currently have lung inflammation.I have a condition that affects my ability to absorb nutrients or swallow pills.I have not had a heart attack or heart disease symptoms in the last 6 months.I am on medication for irregular heartbeats.I am currently being treated for HIV, hepatitis B, or hepatitis C.I have had cancer spread to the lining of my brain and spinal cord.I haven't had major surgery in the last 4 weeks that would interfere with taking the study drug.I have diabetes that requires insulin treatment.My lung cancer is a mix of small cell and non-small cell types.I am not on any strong medication that affects liver enzymes.I have brain metastasis that is not under control.I do not have any uncontrolled illnesses.My organs are working well.I have a history of serious lung disease.I have fluid buildup that isn't being managed.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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