Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy

Inclusion Criteria:

• Ability of participant OR Legally Authorized Representative (LAR) to understand thisstudy, 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 incombination with chemotherapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Measurable disease per RECIST version 1.1
• Diagnoses of advanced/metastatic NSCLC and have failed or are intolerant to 1st lineanti-PD1/PD-L1, either single agent or in combination with chemotherapy, and haveeither exhausted or decline or not be candidates for all available standard of caretherapies.
• Adequate organ function
• Women of child-bearing potential and men with partners of child-bearing potential mustagree to practice sexual abstinence, or to use an acceptable form of contraception forthe 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 andfor 90 days after their last study treatment

Exclusion Criteria:

• 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 periodof 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 exacerbatedby 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- proteinkinase (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 notlimited to, chemotherapy, hormonal therapy, immunotherapy, radiotherapy, and herbaltherapy) for 14 days prior to starting study treatment, depending on the agent andduring study treatment, until disease progression is documented and the patient hasdiscontinued study treatment, with the exception of palliative radiotherapy and localtherapy per PI discretion
• 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 ofstudy 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 coronaryartery 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 wouldinterfere with enteral absorption or results in the inability or unwillingness toswallow 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 equalto 2 weeks prior to initiation of study treatment
• Does not have Grade greater than or equal to 2 uncontrolled or untreatedhypercholesterolemia or hypertriglyceridemia
• Does not have history of or active inflammatory bowel disease (e.g., Crohn's diseaseand 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 pulmonaryfibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history ofopportunistic infections
• Does not have uncontrolled pleural effusion/pericardial effusion/or ascites asdetermined by the investigator
• Does not have active ventricular arrhythmia requiring medication
• Does not have psychiatric illness/social situations that would limit compliance withstudy requirements or compromise the ability of the patient to give written informedconsent
• Is not pregnant, breast feeding or planning to become pregnant while receiving studytreatment 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 childor donate sperm while receiving study treatment or for less than 90 days after thelast dose of study treatment
• Does not have any condition that, in the opinion of the investigator, would interferewith evaluation or interpretation of patient safety or study results