Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Carboplatin

Atezolizumab

Etoposide phosphate

Enzyme Inhibitors

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles

Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression

MPDL3280A

Giuseppe ( Beppe) Giaccone, Md,PhD

This is an open-label study with two parts, a Phase I study and a randomized Phase II study. This study will be conducted at approximately ten sites in the United States. Approximately 178 patients will be enrolled in this trial.

Combining standard chemotherapy with a PD-1/PD-L1 inhibitor holds great appeal in the treatment of SCLC. While this approach may be appropriate for many cancer types, SCLC may be particularly vulnerable to this treatment strategy. Early studies have suggested greater efficacy with agents targeting PD-1/PD-L1 in tumors that are more mutationally complex, such as those associated with tobacco use. SCLC has a strong association with tobacco use and indeed, genome-wide sequencing studies have consistently shown that SCLC carries one of the highest rates of non-synonymous mutations. In addition, MPDL3280A has been safely combined with platinum based chemotherapy doublets in the treatment of NSCLC. Thus, a combination of carboplatin, etoposide and MPDL3280A may significantly improve outcomes in the treatment of SCLC.

Carboplatin Plus Etoposide With or Without MPDL3280A in Untreated Extensive Stage Small Cell Lung Cancer

An Open Label, Randomized Phase I/II Trial of Carboplatin Plus Etoposide With ot Without MPDL3280A in Untreated Extensive Stage Small Cell Lung Cancer

Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and bone scans.

Vanderbilt University

Memorial Sloan Kettering Cancer Center

Giuseppe Giaccone

Associate Director for Clinical Research

Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles MPDL3280A (Atezolizumab) 1200mg iv on day 1 every 21 days until progression

Carboplatin: Standard chemotherapy

Etoposide: Standard chemotherapy

MPDL3280A: Experimental biologic

Carboplatin, Etoposide and MPDL3280A

Carboplatin AUC 5 iv on day 1 every 21 days for 4 cycles Etoposide 100mg/m2 iv on days 1-3 every 21 days for 4 cycles

Carboplatin: Standard chemotherapy

Etoposide: Standard chemotherapy

Carboplatin Plus Etoposide

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

This study enrolled one subject before being terminated early due to recruitment difficulties.That subject was assigned to the Carboplatin, Etoposide, and MPDL3280A arm. No subjects were enrolled to the Carboplatin and Etoposide arm

Dr Giuseppe Giaccone

Progression Free Survival (PFS) With Carboplatin, Etoposide and MPDL3280A Compared to Chemotherapy Alone According to RECIST v1.1

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carboplatin Plus Etoposide With or Without MPDL3280A in Untreated Extensive Stage Small Cell Lung Cancer	NCT02748889	Small Cell Lung...	Carboplatin Etoposide MPDL3280A	18 Years -	Georgetown University
Carboplatin Plus Etoposide With or Without MPDL3280A in Untreated Extensive Stage Small Cell Lung Cancer	NCT02748889	Small Cell Lung...	Carboplatin Etoposide MPDL3280A	18 Years -	Georgetown University
Carboplatin Plus Etoposide With or Without MPDL3280A in Untreated Extensive Stage Small Cell Lung Cancer	NCT02748889	Small Cell Lung...	Carboplatin Etoposide MPDL3280A	18 Years -	Georgetown University

Spots Global Cancer Trial Database for small cell lung cancer ( sclc )