A Randomized, Multi-Cohort Phase II Trial of Temozolomide and Atezolizumab for Subsequent Line Treatment for Small Cell Lung Cancer

Plain English Summary

Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer is a Phase 2 clinical trial sponsored by Dwight Owen studying Extensive Stage Lung Small Cell Carcinoma, Metastatic Lung Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8. Tests temozolomide and atezolizumab as second or third line treatment for metastatic or recurrent small cell lung cancer. For patients over 18 with extensive stage small cell lung cancer who have tried other treatments. Participation involves taking study drugs and regular check-ups. Alternatives include other chemotherapy and immunotherapy treatments. The trial aims to enroll 56 participants.

Official Summary

This phase II trial studies the effects of temozolomide and atezolizumab as second or third line treatment for patients with small cell lung cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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. Giving temozolomide and atezolizumab as second or third line treatment may help prolong survival in patients with small cell lung cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if over 18, in good health, and has had previous treatments for small cell lung cancer. Not eligible if under 18, has severe health issues, or has not responded to previous treatments. Age: 18+ years Health: Good overall health, no severe conditions This trial is studying Extensive Stage Lung Small Cell Carcinoma, Metastatic Lung Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well the treatment works in stopping cancer growth or spreading. The specific primary outcome measures are: Investigator-assessed objective response rate (ORR) (Up to 2 years). 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 a treatment gap for advanced small cell lung cancer, offering a new combination therapy. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Extensive Stage Lung Small Cell Carcinoma, Metastatic Lung Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, where improved treatment options are needed.

Investor Insight

Market size is large, with a competitive landscape, and a moderate approval probability given the unmet need. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about your eligibility and potential side effects. Participation involves taking study drugs and regular check-ups. This trial is currently recruiting participants. The trial is being conducted at 5 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: 56 participants

Interventions

• BIOLOGICAL: Atezolizumab — Given IV
• DRUG: Temozolomide — Given PO

Primary Outcomes

• Investigator-assessed objective response rate (ORR) (Up to 2 years)

Secondary Outcomes

• Treatment related adverse events (Up to 2 years)
• Progression free survival (PFS) (From initiation of investigational therapy until the criteria for disease progression is met as defined by RECIST1.1 or death as a result of any cause, assessed up to 2 years)
• Intracranial PFS (At 6 months from start of investigational therapy)
• Overall survival (Date of initiation of investigational therapy to date of death from any cause, assessed up to 2 years)

Full Eligibility Criteria

Inclusion Criteria:

* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information

  * NOTE: HIPAA authorization may be included in the informed consent or obtained separately
* Age \>= 18 years at the time of consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 within 28 days prior to registration
* Have histologically or cytologically-documented diagnosis of extensive stage (i.e. metastatic and/or recurrent) small cell lung cancer and have progressed or recurred after platinum-based chemotherapy with immunotherapy. Eligible patients will be defined as follows:

  * "Sensitive" Disease: Patients who had one previous line of chemotherapy and relapsed after \> 90 days of completion of treatment
  * "Resistant" Disease: Patients with no response to first-line chemo-immunotherapy or progression \< 90 days after completing treatment
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to registration
* Maximum of 3 prior lines of systemic therapy is allowed in the setting of metastatic disease. Patients who recur after treatment for limited state disease, and who receive first line metastatic treatment with chemo-immunotherapy would be considered eligible upon progression on chemo-IO in the metastatic setting
* Absolute neutrophil count (ANC) \>= 1.5 K/mm\^3 (obtained within 28 days prior to registration)
* Platelets \>= 100,000 / mcL (obtained within 28 days prior to registration)
* Serum creatinine =\< 2.0 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 50 mL/min as estimated by Cockcroft and Gault formula for subject with creatinine levels \> 2 x institutional ULN (obtained within 28 days prior to registration)
* Bilirubin =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN

  * Patients with known Gilbert disease: serum bilirubin =\< 3 x ULN) (obtained within 28 days prior to registration)
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =\< 3 X ULN OR =\< 5 X ULN for subjects with liver metastases (obtained within 28 days prior to registration)
* Albumin \> 2.5 g/dL (obtained within 28 days prior to registration)
* International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 x ULN for patients not receiving therapeutic anticoagulation (obtained within 28 days prior to registration)

  * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
* Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN for patients not receiving therapeutic anticoagulation (obtained within 28 days prior to registration)

  * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
* Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration
* For women of childbearing potential: agreement to remain abstinent (refrain from vaginal intercourse) or use contraceptive methods and agreement to refrain from donating eggs, as defined below:

  * Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab or temozolomide. Women must refrain from donating eggs during this same period
  * Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices
  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, or post ovulation methods) and withdrawal are not adequate methods of contraception
* For men able to father a child: agreement to remain abstinent (refrain from vaginal intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:

  * With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 3 months after the final dose of temozolomide to avoid exposing the embryo. Men must refrain from donating sperm during this same period
  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception
* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with st

Trial Locations

• University of Illinois Cancer Center, Chicago, Illinois, United States
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
• Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
• University of Wisconsin, Madison, Wisconsin, United States

Frequently Asked Questions

Related Conditions

• Small cell lung cancer, extensive stage lung cancer, metastatic lung cancer, recurrent lung cancer, stage IV lung cancer, stage IVA lung cancer, stage IVB lung cancer

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