scholarly journals 114TiP KEYNOTE-B99: Phase II study of pembrolizumab plus investigational agents combined with chemotherapy as first-line therapy for extensive-stage small cell lung cancer (ES-SCLC)

2021 ◽  
Vol 32 ◽  
pp. S1425
Author(s):  
N. Peled ◽  
D. Rodriguez-Abreu ◽  
R. Bordoni ◽  
P.M. Ellis ◽  
M. Hochmair ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii Study ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Extensive Stage ◽  
Investigational Agents

Phase II Study of Irinotecan Plus Cisplatin as First Line therapy in Extensive Small-Cell Lung Cancer

2006 ◽  
Vol 61 (2) ◽  
pp. 143
Author(s):  
Ki Eun Hwang ◽  
So Young Kim ◽  
Jong Hoon Jung ◽  
Seong Hoon Park ◽  
Jung Hyun Park ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Phase Ii Study ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

Phase II study of ADI-PEG 20 in patients with relapsed sensitive or refractory small cell lung cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e17558-e17558 ◽  
Author(s):  
Sinhan Tran ◽  
Neal Ready ◽  
Lee M. Krug ◽  
Maria Catherine Pietanza ◽  
Achim A Jungbluth ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Second Stage ◽  
First Line Therapy ◽  
Line Therapy

e17558 Background: Small cell lung cancer (SCLC) is a rapidly progressing malignancy. The majority of patients show relapse after initial therapy. Second-line chemotherapy has limited activity, and alternative therapies are desperately needed. ADI-PEG 20 is pegylated recombinant arginine deiminase which degrades arginine, resulting in growth inhibition of SCLC tumor cells deficient in argininosuccinate synthetase (ASS) in xenografts and in vitro, and induction of sensitivity to cell autophagy. Based on ASS deficiency identified in ~50% of human SCLC, a phase II trial in patients with relapsed SCLC was initiated. Methods: This is an open label, multicenter, phase II study of ADI-PEG 20 in subjects with relapsed SCLC. The primary objective is to determine overall response rate according to RECIST. Secondary objectives are to measure safety, overall survival, pharmacodynamics, and immunogenicity. Patients with histologically documented SCLC, measurable disease, and ASS negative (by immunohistochemistry) or weakly positive (< 5%) tumor are eligible. Patients with severe comorbidities, metastatic disease of the central nervous system, prior treatment with 3 or more lines of chemotherapy, and known allergy to pegylated products are excluded. Patients are enrolled in either Cohort 1 (Sensitive disease—response to first-line therapy maintained ≥ 90 days) or Cohort 2 (Refractory disease—no response to first-line therapy or progression within 90 days, or progression after 2 lines of therapy). All patients receive weekly intramuscular injections of ADI-PEG 20 at a dose of 320 IU/m2 (36.8 mg/m2) until disease progression. The two cohorts will be analyzed separately with a two-stage design. For Cohort 1, if 3/15 patients respond, additional 13 patients will be accrued to the second stage. For Cohort 2, if 1/9 patients responds, additional 8 patients will be accrued to the second stage. Results: Cohort 1 has enrolled 2 of planned 15 patients and Cohort 2 has enrolled 7 of 9 planned patients. Conclusions: Will be published when study is complete.

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