SWOG clinical trial number
S1929

Phase II Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (SCLC)

Open
Phase
II
Accrual
3%
Abbreviated Title
Phase II Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (SCLC)
Status Notes
S1929 will open to accrual June 15, 2020, effective 12:00 pm PST.
Activated
06/15/2020

Eligibility Criteria Expand/Collapse

STEP 1 SCREENING REGISTRATION:
-Histologically or pathologically confirmed extensive stage small cell lung cancer (ES-SCLC)
-Completed at least one cycle of frontline induction with platinum + etoposide + atezolizumab prior reg. (Cycle 1 of frontline induction may or may not contain atezolizumab).
-No immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC
-No prior investigational agent for the treatment of ES-SCLC
->/= 18 years of age
-Adequate tumor tissue must be available from a core biopsy and pt must agree to tissue submission for SLFN11 IHC.

STEP 2: RANDOMIZATION:
-Site must have received notification from the SDMC that tumor sample is SLFN11 positive.
-No disease progression.
-Measurable (w/in 28 days) or non-measurable (w/in 42 days) disease by CT or PET/CT of chest, abdomen, and pelvis (with contrast, unless contraindicated).
-CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to Step 2. No leptomeningeal disease, spinal cord compression or brain metastases unless: (1) mets are treated, controlled, and asymptomatic for at least 14 days after tx and prior to Step 2, AND (2) pt has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2.
-Must be registered to Step 2 prior to the start of maintenance atezolizumab.
-Must have received 2-4 cycles of induction treatment with platinum/etoposide/atezolizumab.
-Must have RT or prophylactic cranial irradiation (PCI) within 14 days prior to Step 2.
-No strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors within 7 days prior to randomization or during tx.
-Pts must not have experienced the following during induction treatment: >/= Grade 3 irAE [exception: asymptomatic nonbullous/nonexfoliative rash], unresolved Grade 2 irAE, any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy [exception: Toxicities of any grade that require replacement therapy and have stabilized on therapy].
-Must have history and physical within 28 days prior to Step 2.
-No known clinically significant liver disease.
-No end stage renal or other serious medical illness that may limit survival or the ability to participate in this study.
-No history of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
-No known active TB.
-Adequate cardiac function
-No prior allogeneic bone marrow transplantation or prior solid organ transplantation.
-No history of allergic reaction attributed to compounds of similar chemical or biological composition to atezolizumab and/or talazoparib.
-No prior or concurrent malignancy whose natural history or treatment might interfere with the safety or efficacy assessment of the investigational regimen.
-Zubrod performance status 0-2 within 28 days prior to Step 2.
-Normal organ and marrow function within 28 days prior to Step 2 Randomization defined as: Leukocytes >/= 3,000/mcL, Absolute neutrophil count >/= 1,500/mcL, Platelets >/= 100,000/mcL, Total bilirubin </= institutional upper limit of normal (ULN), AST/ALT </= 3 x institutional ULN, Creatinine </= institutional ULN OR estimated creatinine clearance > 30 mL/min.
-Pts with evidence of chronic HBV must have undetectable HBV viral load on suppressive therapy within in 6 months prior to Step 2.
-Pts with a history of hepatitis C virus (HCV) infection must have been treated and cured or if currently on treatment must have an undetectable HCV viral load within in 6 months prior to Step 2.
-Pts with known HIV must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Step 2.
-Pts with known diabetes must not have uncontrolled diabetes.
-Pts must not be on corticosteroids at doses greater than prednisone 10 mg daily or equivalent within 7 days prior to Step 2.
-Pts must not receive plan to receive any live attenuated vaccines from 28 days prior to Step 2 until 5 months after the last dose of protocol treatment.
-Pts must not have severe infections in the form of severe sepsis or septic shock within 14 days prior to Step.
-Pts must be able to swallow capsule whole.
-Pts must not be pregnant or nursing and must have agreed to use an effective contraception method for the duration of protocol treatment and for 7 months after the last dose of protocol treatment
-Pts must be offered the opportunity to participate in specimen banking.