Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer

Conditions

• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jan 26, 2022

Status verified

Apr 2026

Primary completion

Dec 30, 2027

Completion

Dec 30, 2028

Study Design

Enrollment

56 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort I (atezolizumab, temozolomide)
  Patients receive atezolizumab IV over 30-60 minutes on day 1 and temozolomide PO QD on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Cohort II (atezolizumab, temozolomide)
  Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive temozolomide PO QD on days 1-14 of cycle 1 and days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Investigator-assessed objective response rate (ORR) [ Time Frame: Up to 2 years ]

Central Contacts

• Dwight Owen
  614-685-2039
  [email protected]
• Amber Ryba
  317-634-5842
  [email protected]

Locations (5)

Find similar trials in Chicago, IL

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