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

Plain English Summary

Testing Maintenance Therapy for Small Cell Lung Cancer in Patients With SLFN11 Positive Biomarker is a Phase 2 clinical trial sponsored by National Cancer Institute (NCI) studying Extensive Stage Lung Small Cell Carcinoma. This trial compares atezolizumab alone vs. atezolizumab with talazoparib to see which works better for SLFN11-positive extensive-stage small cell lung cancer. Eligible patients must have completed induction therapy and have SLFN11-positive cancer. They will receive either atezolizumab alone or in combination with talazoparib. Participation involves regular check-ups, blood tests, and imaging scans to monitor the cancer and side effects. Alternative treatments include standard chemotherapy and immunotherapy. The trial aims to enroll 103 participants.

Official Summary

This phase II trial studies whether atezolizumab in combination with talazoparib works better than atezolizumab alone as maintenance therapy for patients with SLFN11-positive extensive-stage small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. PARPs are proteins that help repair damage to DNA, the genetic material that serves as the body's instruction book. Changes (mutations) in DNA can cause tumor cells to grow quickly and out of control, but PARP inhibitors like talazoparib may keep PARP from working, so tumor cells can't repair themselves, and they stop growing. Giving atezolizumab in combination with talazoparib may help lower the chance of extensive-stage small cell lung cancer growing and spreading compared to atezolizumab alone.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible patients must be 18 years or older with SLFN11-positive extensive-stage small cell lung cancer who have completed induction therapy. Patients cannot have received prior immunotherapy or investigational agents for SCLC. Participants must have adequate tumor tissue available for SLFN11 testing. Impaired decision-making capacity is allowed as long as it does not affect safe participation. This trial is studying Extensive Stage Lung Small Cell Carcinoma, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the time until the cancer progresses, which is crucial for patients to understand their potential response to the treatment. The specific primary outcome measures are: Progression free survival (From the date of maintenance randomization to the date of first document of progression or symptomatic deterioration, or death due to any cause, assessed up to 18 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to fill the treatment gap by evaluating a new combination therapy for a specific subtype of small cell lung cancer. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Extensive Stage Lung Small Cell Carcinoma, where improved treatment options are needed.

Investor Insight

The market size for small cell lung cancer treatments is significant, with this trial potentially offering a new therapeutic option in a competitive landscape. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if you have SLFN11-positive extensive-stage small cell lung cancer and have completed induction therapy. Understand the risks and benefits of participating in the trial before making a decision. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 103 participants

Interventions

• DRUG: Atezolizumab — Given IV
• PROCEDURE: Biopsy Procedure — Undergo tumor biopsy
• PROCEDURE: Biospecimen Collection — Undergo blood sample collection
• PROCEDURE: Computed Tomography — Undergo CT scan
• PROCEDURE: Magnetic Resonance Imaging — Undergo MRI

Primary Outcomes

• Progression free survival (From the date of maintenance randomization to the date of first document of progression or symptomatic deterioration, or death due to any cause, assessed up to 18 months)

Secondary Outcomes

• Overall survival (From the date of maintenance randomization until death from any cause, with participants last known to be alive censored at the date of last contact, assessed up to 3 years from randomization)

Full Eligibility Criteria

Inclusion Criteria:

* STEP 1: SCREENING REGISTRATION: Participants must have histologically or pathologically confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) at the time of protocol entry. Participants who have transformed to SCLC from lung non-small cell carcinoma (NSCLC) or have SCLC with mixed histology are not eligible
* STEP 1: SCREENING REGISTRATION: Participants must have completed at least day 3 of cycle 1 dosing of frontline induction treatment with platinum plus etoposide plus atezolizumab prior to Step 1 Screening Registration. Cycle 1 of frontline induction treatment may or may not contain atezolizumab

  * NOTE: Participants may be screened while receiving consolidation thoracic radiation or during prophylactic cranial irradiation (PCI) at the time of Step 1 Screening Registration. Participants may or may not receive consolidation thoracic radiation and/or PCI per the discretion of their treating investigator
* STEP 1: SCREENING REGISTRATION: Participants must not have received any immunotherapy for SCLC prior to starting the frontline induction treatment for ES-SCLC
* STEP 1: SCREENING REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC
* STEP 1: SCREENING REGISTRATION: Participants must be \>= 18 years of age at the time of Step 1 Screening Registration
* STEP 1: SCREENING REGISTRATION: Participants must have adequate tumor tissue available from a core biopsy or fine needle aspiration (FNA) defined as:

  * At least two (3-5 microns) (three slides preferred) unstained slides, or;
  * One (3-5 microns) (two slides preferred) unstained slide plus one H\&E stained slide
  * Participants must agree to have this tissue submitted to M.D. Anderson Cancer Center (MDACC) for SLFN11 immunohistochemistry (IHC) testing. Note: A histologic review will be performed at MDACC to confirm adequate cellularity for the testing. If inadequate cellularity, additional unstained slides from the same participant may be submitted if it doesn't exceed the window of starting maintenance therapy
* STEP 1: SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
* STEP 1: SCREENING REGISTRATION: As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* STEP 1: SCREENING REGISTRATION: Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)
* STEP 2: RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) that the participant's tumor sample is SLFN11 positive
* STEP 2: RANDOMIZATION: Participants must have their disease assessed after completion of induction therapy dosing either by computed tomography (CT) of chest/abdomen/pelvis (with contrast, unless contraindicated) within 28 days prior to Step 2 Registration for measurable disease or by positron emission tomography (PET)PET/CT of chest/abdomen/pelvis (with contrast, unless contraindicated) within 42 days prior to Step 2 Registration for non-measurable disease. Participants may have a complete response to induction therapy. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). Study participants will not be considered eligible if a non-diagnostic PET/CT of chest/abdomen/pelvis is used to assess measurable disease prior to Step 2 Registration
* STEP 2: RANDOMIZATION: Patients must have a CT or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to Step 2 randomization. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to Step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to Step 2 randomization
* STEP 2: RANDOMIZATION: Participants must not have had disease progression based on post induction imaging in the opinion of treating investigator
* STEP 2: RANDOMIZATION: Participants must be registered to Step 2 Randomization prior to the start of maintenance atezolizumab
* STEP 2: RANDOMIZATION: Participants must have received no fewer than 2 cycles and no more than 4 cycles of induction treatment with platinum/etoposide/atezolizumab
* STEP 2: RANDOMIZATION: Participant must not ha

Trial Locations

• Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
• Anchorage Radiation Therapy Center, Anchorage, Alaska, United States
• Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
• Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
• Alaska Women's Cancer Care, Anchorage, Alaska, United States
• Anchorage Oncology Centre, Anchorage, Alaska, United States
• Katmai Oncology Group, Anchorage, Alaska, United States
• Providence Alaska Medical Center, Anchorage, Alaska, United States
• Kingman Regional Medical Center, Kingman, Arizona, United States
• Cancer Center at Saint Joseph's, Phoenix, Arizona, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Small cell lung cancer
• Lung cancer
• Immunotherapy
• PARP inhibitors
• Maintenance therapy

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