OncoMatch/Clinical Trials/NCT06110572
Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation
Is NCT06110572 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Atezolizumab and Carboplatin for extensive stage lung small cell carcinoma.
Treatment: Carboplatin · Atezolizumab · Etoposide — This phase I/II trial studies the side effects, safety, and effectiveness of low dose radiation to the entire body (total body irradiation \[TBI\]) and higher dose radiation to known areas of cancer (hypofractionated radiation therapy \[H-RT\]) combined with atezolizumab and chemotherapy (carboplatin \& etoposide) in treating patients with small cell lung cancer that has spread to disease sites outside of the lung (extensive stage). Extensive stage disease has historically been treated with chemotherapy alone with consideration of chest (thoracic) radiation therapy for those with response to chemotherapy, as well as consideration of preventative radiation therapy to the head (prophylactic cranial irradiation). Emerging evidence supports the synergistic interactions between immunotherapy and radiation therapy. 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. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Combining TBI and H-RT with atezolizumab and chemotherapy may improve response to treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage IV, M1 (AJCC 8TH EDITION), STAGE IV (AJCC 8th edition)
extensive stage small-cell lung cancer with evaluable disease per RECIST v1.1 criteria. Patients may be considered extensive-stage based on M1 disease per AJCC 8th edition, OR may be clinically staged as extensive-stage disease based on anatomical extent that would preclude the use of standard radiotherapy fields as assessed by the treating radiation oncologist.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cytotoxic chemotherapy or anti-neoplastic biologic/immunotherapy for current malignancy (other than the current course of therapy)
Exception: Patients may have undergone 1 cycle of 1st line of systemic therapy for SCLC prior to enrollment as long as the systemic therapy is congruent with what is included in the protocol and part of the current course of therapy.
Receipt of prior courses of cytotoxic chemotherapy or anti-neoplastic biologic/immunotherapy for current malignancy (other than the current course of therapy). Patients may have undergone 1 cycle of 1st line of systemic therapy for SCLC prior to enrollment as long as the systemic therapy is congruent with what is included in the protocol and part of the current course of therapy.
Cannot have received: radiotherapy
Exception: Prior radiotherapy that would preclude delivery of protocol-based radiotherapy to normal organ tolerance per patient's study physician
Prior radiotherapy that would preclude delivery of protocol-based radiotherapy to normal organ tolerance per patient's study physician
Cannot have received: live attenuated vaccine
Receipt of live attenuated vaccine within 28 days of cycle 1, day 1 (C1D1), and for 5 months after the last dose of atezolizumab.
Cannot have received: CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, and anti-PD-L1 therapeutic antibodies
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, and anti-PD-L1 therapeutic antibodies
Cannot have received: systemic immunostimulatory agents (interferon, interleukin 2 (IL-2))
Treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin 2 (IL-2) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Cannot have received: systemic immunosuppressive medication (corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF-alpha agents)
Exception: Acute, low-dose or one-time pulse dose systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) allowed after PI confirmation; mineral corticoids, corticosteroids for COPD/asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal sufficiency allowed; systemic steroids required during therapy for AE management are allowed.
Treatment with systemic immunosuppressive medication including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents, within 2 weeks prior to initiation of study treatment with following exceptions: Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy are eligible for the study after Principal Investigator confirmation has been confirmed); Patients who are receiving mineral corticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal sufficiency are eligible for the study. Systemic steroids required during therapy for adverse event (AE) management are allowed.
Cannot have received: investigational therapy
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Lymphocyte count ≥ 0.5 x 10^9/L; Hemoglobin ≥ 9 g/dL
Kidney function
Creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) ≥ 50 mL/min if creatinine > 1.5 x ULN. GFR can also be utilized.
Liver function
Total bilirubin ≤ 1.5 x ULN; AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN
ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; Lymphocyte count ≥ 0.5 x 10^9/L; Hemoglobin ≥ 9 g/dL; Total bilirubin ≤ 1.5 x ULN; AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) ≥ 50 mL/min if creatinine > 1.5 x ULN. GFR can also be utilized.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Vanderbilt University/Ingram Cancer Center · Nashville, Tennessee
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