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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients

Excerpt:
...1) Have a full understanding of this study and voluntarily sign an informed consent form (ICF) 2)Phase I dose escalation : the patients with advanced ALK-positive malignant solid tumor who have progressed on standard therapies;...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

SAF-189s in advanced, ALK-positive, non–small cell lung cancer: Results from a first-in-human phase 1/2, multicenter study.

Published date:
05/26/2022
Excerpt:
Median progression-free survival (PFS) was 33.1 and 22.1 months (95% CI 6.9–not reached: 13.8–26.6) in ALKi-naive and ALKi-pretreated patients, respectively. Disease control rates (DCRs) were 100% in both ALKi-naive and ALKi-pretreated patients….SAF-189s showed clinical antitumor activity and was well tolerated in patients with advanced, ALK+ NSCLC, including those with brain metastases and pretreated with crizotinib. SAF-189s represents a promising, next-generation, targeted therapy for patients with ALK+ NSCLC.
DOI:
10.1200/JCO.2022.40.16_suppl.9076
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

SAF-189s in previously treated patients with advanced ALK-rearranged non-small cell lung cancer (NSCLC): Results from the dose-finding portion in a single-arm, first-in-human phase I/II study.

Published date:
05/28/2020
Excerpt:
...SAF-189s was safe, very tolerable, and demonstrated both systemic and intracranial activity in pts with advanced ALK-positive NSCLC who had failed to at least 1 prior systemic therapy.
DOI:
10.1200/JCO.2020.38.15_suppl.e21689
Trial ID: