Vactosertib in Combination With Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects
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|ClinicalTrials.gov Identifier: NCT04515979|
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : September 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV||Phase 2|
Approximately 55 NSCLC subjects with PD-L1 tumor proportion score (TPS) ≥ 1% are expected to be enrolled in this study. Subjects' TPS will be determined by PD-L1 IHC 22C3 pharmDx assay performed according to local laboratory regulations prior to study enrollment.
Subjects who received adjuvant or neoadjuvant therapy are permitted onto the study if the therapy was completed at least 12 months prior to the development of metastatic disease.
Eligible subjects will receive:
• Vactosertib 300 mg orally (PO) BID for 5 days with 2 days off period (5 days on/2days off) and pembrolizumab 200 mg IV on Day 1 of every 3-week cycle (Q3W).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of Vactosertib in Combination With Pembrolizumab as a First-line Treatment for Subjects With PD-L1 Positive Advanced Non-Small Cell Lung Cancer|
|Actual Study Start Date :||December 17, 2020|
|Estimated Primary Completion Date :||August 1, 2022|
|Estimated Study Completion Date :||December 30, 2025|
Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks
Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV
Vactosertib 300 mg orally (PO) BID(5 days on/2days off) and pembrolizumab 200 mg IV (Q3W).
- ORR per RECIST 1.1 [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years ]ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515979
|Contact: kyounghee firstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 06351|
|Contact: Sㄷ-hoon Lee, Phd|
|Study Director:||Bitna Oh, MD||MedPacto, Inc.|